res_code,treatment_phase,authority_method,treatment_of_code,restriction_number,li_html_text,schedule_html_text,note_indicator,caution_indicator,complex_authority_rqrd_ind,assessment_type_code,criteria_relationship,variation_rule_applied,first_listing_date,written_authority_required,schedule_code
"10041_6898_R","null","STREAMLINED","6898","10041","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe behavioural disturbances</p><br/><p>Patient must have autism spectrum disorder; AND</p> <p>The treatment must be under the supervision of a paediatrician or psychiatrist; AND</p> <p>The treatment must be in combination with non-pharmacological measures; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.</p> <p align=""justify"">The diagnosis of autism spectrum disorder must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD-10 international classification of mental and behavioural disorders.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe behavioural disturbances</p><br/><p>Patient must have autism spectrum disorder; AND</p> <p>The treatment must be under the supervision of a paediatrician or psychiatrist; AND</p> <p>The treatment must be in combination with non-pharmacological measures; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.</p> <p align=""justify"">The diagnosis of autism spectrum disorder must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD-10 international classification of mental and behavioural disorders.</p>","N","N","N","IMMEDIATE","ALL","N","2020-01-01","N","4708"
"10045_10033_R","Initial treatment","STREAMLINED","10033","10045","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must be receiving PBS subsidised vemurafenib concomitantly for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must be receiving PBS subsidised vemurafenib concomitantly for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2020-01-01","N","4708"
"10046_10021_R","Continuing treatment, trial of dose reduction or cessation of treatment","AUTHORITY_REQUIRED","10021","10046","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Behavioural disturbances</p><br/><p>Continuing treatment, trial of dose reduction or cessation of treatment</p><br/><p>The condition must be characterised by psychotic symptoms and aggression; AND</p> <p>Patient must have dementia of the Alzheimer type; AND</p> <p>Patient must have responded to an initial course of treatment with this drug for this condition; AND</p> <p>Patient must have failed to respond to non-pharmacological methods of treatment; AND</p> <p>The treatment must be for dose tapering purposes as part of a trial of treatment reduction or cessation; or</p> <p>Patient must have trialled a period of treatment reduction or cessation with this drug for this condition and experienced worsening or re-emergence of symptoms during this trial, and retrials are considered periodically; AND</p> <p>Patient must be optimised on non-pharmacological methods of treatment.</p> <p align=""justify"">The patient&apos;s response to treatment and a trial of treatment reduction or cessation must be discussed formally with a psychiatrist or geriatrician or in a documented clinical review process involving a least one other medical practitioner, or be reviewed by a psychiatrist or geriatrician.</p> <p align=""justify"">Response to treatment is defined as a significant reduction in symptoms of psychosis or aggression.</p> <p align=""justify"">Patients must cease treatment if there is no improvement in symptoms of psychosis and aggression, or worsening of symptoms with therapy.</p> <p align=""justify"">Patients must be monitored for adverse effects such as falls, drowsiness leading to reduced self-care, incontinence, reduced nutrition, reduced ability to communicate needs/wishes and take part in activities. Therapy must be ceased if harms of therapy outweigh benefits.</p> <p align=""justify"">Trials of reduction or cessation of therapy should be considered periodically with the intention of maintaining symptom control through non-pharmacological measures wherever possible and/or lowest effective dose therapy.</p> <p align=""justify"">Evidence of patient benefit from therapy, failure of non-pharmacological approaches to manage symptoms in the absence of therapy, and recurrence of symptoms following reduction or cessation of therapy, trialled on at least 1 occasion, must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Behavioural disturbances</p><br/><p>Continuing treatment, trial of dose reduction or cessation of treatment</p><br/><p>The condition must be characterised by psychotic symptoms and aggression; AND</p> <p>Patient must have dementia of the Alzheimer type; AND</p> <p>Patient must have responded to an initial course of treatment with this drug for this condition; AND</p> <p>Patient must have failed to respond to non-pharmacological methods of treatment; AND</p> <p>The treatment must be for dose tapering purposes as part of a trial of treatment reduction or cessation; or</p> <p>Patient must have trialled a period of treatment reduction or cessation with this drug for this condition and experienced worsening or re-emergence of symptoms during this trial, and retrials are considered periodically; AND</p> <p>Patient must be optimised on non-pharmacological methods of treatment.</p> <p align=""justify"">The patient&apos;s response to treatment and a trial of treatment reduction or cessation must be discussed formally with a psychiatrist or geriatrician or in a documented clinical review process involving a least one other medical practitioner, or be reviewed by a psychiatrist or geriatrician.</p> <p align=""justify"">Response to treatment is defined as a significant reduction in symptoms of psychosis or aggression.</p> <p align=""justify"">Patients must cease treatment if there is no improvement in symptoms of psychosis and aggression, or worsening of symptoms with therapy.</p> <p align=""justify"">Patients must be monitored for adverse effects such as falls, drowsiness leading to reduced self-care, incontinence, reduced nutrition, reduced ability to communicate needs/wishes and take part in activities. Therapy must be ceased if harms of therapy outweigh benefits.</p> <p align=""justify"">Trials of reduction or cessation of therapy should be considered periodically with the intention of maintaining symptom control through non-pharmacological measures wherever possible and/or lowest effective dose therapy.</p> <p align=""justify"">Evidence of patient benefit from therapy, failure of non-pharmacological approaches to manage symptoms in the absence of therapy, and recurrence of symptoms following reduction or cessation of therapy, trialled on at least 1 occasion, must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2020-01-01","N","4708"
"10058_10051_R","Initial treatment","STREAMLINED","10051","10058","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2020-01-01","N","4708"
"10059_10020_R","Initial treatment","STREAMLINED","10020","10059","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Behavioural disturbances</p><br/><p>Initial treatment</p><br/><p>The condition must be characterised by psychotic symptoms and aggression; AND</p> <p>Patient must have dementia of the Alzheimer type; AND</p> <p>Patient must have failed to respond to non-pharmacological methods of treatment; AND</p> <p>Patient must not receive more than 12 weeks of treatment under this restriction.</p> <p align=""justify"">A patient may only qualify for 12 weeks of PBS-subsidised treatment under this restriction once in a 12 month period.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Behavioural disturbances</p><br/><p>Initial treatment</p><br/><p>The condition must be characterised by psychotic symptoms and aggression; AND</p> <p>Patient must have dementia of the Alzheimer type; AND</p> <p>Patient must have failed to respond to non-pharmacological methods of treatment; AND</p> <p>Patient must not receive more than 12 weeks of treatment under this restriction.</p> <p align=""justify"">A patient may only qualify for 12 weeks of PBS-subsidised treatment under this restriction once in a 12 month period.</p>","N","N","N","IMMEDIATE","ALL","N","2020-01-01","N","4708"
"10063_10063_R","Continuing treatment","STREAMLINED","10063","10063","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.</p> <p align=""justify"">During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient&apos;s response and tolerability.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.</p> <p align=""justify"">During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient&apos;s response and tolerability.</p> <p align=""justify"">&quot;Sustained&quot; means the abnormality was detected on at least 2 blood samples collected over a period of 2 to 4 months.</p>","N","N","N","IMMEDIATE","ALL","N","2020-02-01","N","4708"
"10067_10067_R","Continuing treatment","STREAMLINED","10067","10067","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.</p> <p align=""justify"">During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient&apos;s response and tolerability.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.</p> <p align=""justify"">During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient&apos;s response and tolerability.</p> <p align=""justify"">&quot;Sustained&quot; means the abnormality was detected on at least 2 blood samples collected over a period of 2 to 4 months.</p>","N","N","N","IMMEDIATE","ALL","N","2020-02-01","N","4708"
"10068_10068_R","Continuing treatment","STREAMLINED","10068","10068","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Continuing treatment</p><br/><p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have achieved a decrease of at least 30% in intact parathyroid hormone (iPTH) concentrations after 6 months treatment; or</p> <p>Patient must have an intact parathyroid (iPTH) concentration greater than 15 pmol/L and an (adjusted) serum calcium concentration of less than 2.6 mmol/L after 6 months.</p> <p align=""justify"">During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.</p> <p align=""justify"">During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient&apos;s response and tolerability.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Continuing treatment</p><br/><p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have achieved a decrease of at least 30% in intact parathyroid hormone (iPTH) concentrations after 6 months treatment; or</p> <p>Patient must have an intact parathyroid (iPTH) concentration greater than 15 pmol/L and an (adjusted) serum calcium concentration of less than 2.6 mmol/L after 6 months.</p> <p align=""justify"">During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.</p> <p align=""justify"">During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient&apos;s response and tolerability.</p>","N","N","N","IMMEDIATE","ALL","N","2020-02-01","N","4708"
"10073_10073_R","Initial treatment","AUTHORITY_REQUIRED","10073","10073","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Initial treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have failed to respond to conventional therapy; AND</p> <p>Patient must have sustained hyperparathyroidism with iPTH of at least 50 pmol per L; or</p> <p>Patient must have sustained hyperparathyroidism with iPTH of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L.</p> <p align=""justify"">During the titration phase, intact PTH (iPTH) should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved.</p> <p align=""justify"">During the titration phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient&apos;s response and tolerability.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondary hyperparathyroidism</p><br/><p>Initial treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have chronic kidney disease; AND</p> <p>Patient must be on dialysis; AND</p> <p>Patient must have failed to respond to conventional therapy; AND</p> <p>Patient must have sustained hyperparathyroidism with iPTH of at least 50 pmol per L; or</p> <p>Patient must have sustained hyperparathyroidism with iPTH of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L.</p> <p align=""justify"">During the titration phase, intact PTH (iPTH) should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved.</p> <p align=""justify"">During the titration phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient&apos;s response and tolerability.</p> <p align=""justify"">&quot;Sustained&quot; means the abnormality was detected on at least 2 blood samples collected over a period of 2 to 4 months.</p>","N","N","N","IMMEDIATE","ALL","N","2020-02-01","N","4708"
"10080_10076_R","Initial treatment","AUTHORITY_REQUIRED","10076","10080","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia</p><br/><p>Initial treatment</p><br/><p>Must be treated by a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.</p> <p align=""justify"">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia</p><br/><p>Initial treatment</p><br/><p>Must be treated by a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.</p> <p align=""justify"">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p> <p align=""justify"">Patient will be eligible for a maximum of one PBS-subsidised prescription as initial therapy to enable their response to treatment with sapropterin to be assessed.</p>","N","N","N","IMMEDIATE","ALL","N","2020-02-01","N","4708"
"10086_10121_R","null","STREAMLINED","10121","10086","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>Patient must have significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND</p> <p>Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>Patient must have significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND</p> <p>Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months.</p> <p/><p align=""justify"">This product is not indicated for the initiation of bronchodilator therapy in COPD. </p><p/> <p align=""justify"">The treatment must not be used in combination with LABA monotherapy or LAMA/LABA combination therapy.</p> <p align=""justify"">A LAMA/LABA includes aclidinium/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, or umeclidinium/vilanterol.</p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p>","N","N","N","IMMEDIATE","ALL","N","2020-03-01","N","4708"
"10087_10157_R","Initial treatment","STREAMLINED","10157","10087","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; or</p> <p>Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND</p> <p>Patient must have a WHO performance status of 2 or less.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; or</p> <p>Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND</p> <p>Patient must have a WHO performance status of 2 or less.</p> <p/><p align=""justify"">A patient who has had progressive disease when treated with another BRAF inhibitor is not eligible to receive PBS-subsidised treatment with this drug.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2020-03-01","N","4708"
"10089_4295_R","null","RESTRICTED","4295","10089","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p> <p align=""justify"">This product is low in folic acid, choline and methionine and is not intended as a sole source of nutrition.</p>","N","N","N","IMMEDIATE","ALL","N","2020-03-01","N","4708"
"10095_10095_R","null","RESTRICTED","10095","10095","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe eye inflammation</p><br/><p>Patient must have had a cataract removed in the treated eye; or</p> <p>Patient must be scheduled for cataract surgery in the treated eye; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe eye inflammation</p><br/><p>Patient must have had a cataract removed in the treated eye; or</p> <p>Patient must be scheduled for cataract surgery in the treated eye; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2020-03-01","N","4708"
"10138_10138_R","null","STREAMLINED","10138","10138","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic.</p> <p align=""justify"">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p>","N","N","N","IMMEDIATE","ALL","N","2020-03-01","N","4708"
"10161_10161_R","null","STREAMLINED","10161","10161","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic.</p> <p align=""justify"">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p>","N","N","N","IMMEDIATE","ALL","N","2020-03-01","N","4708"
"10164_10125_R","Initial treatment 2","STREAMLINED","10125","10164","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment 2</p><br/><p>Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND</p> <p>Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment 2</p><br/><p>Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND</p> <p>Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer.</p>","N","N","N","IMMEDIATE","ALL","N","2020-03-01","N","4708"
"10185_5883_R","null","RESTRICTED","5883","10185","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cellulitis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cellulitis</p>","N","N","N","IMMEDIATE","ALL","N","2020-03-01","N","4708"
"10190_N","null","null","null","null","null","<p>Temozolomide is not PBS-subsidised for use in conjunction with PBS-subsidised carmustine.</p>","Y","N","N","null","null","N","2014-04-01","N","4708"
"10200_10116_R","Continuing treatment","STREAMLINED","10116","10200","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection.</p>","N","N","N","IMMEDIATE","ALL","N","2020-03-01","N","4708"
"10211_10310_R","Continuing treatment","STREAMLINED","10310","10211","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10249_10248_R","null","AUTHORITY_REQUIRED","10248","10249","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 12 weeks.</p> <p align=""justify""><br/>The application must include details of the prior treatment regimen containing an NS5A inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 12 weeks.</p> <p align=""justify""><br/>The application must include details of the prior treatment regimen containing an NS5A inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10253_10212_R","3 weekly treatment regimen","STREAMLINED","10212","10253","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>3 weekly treatment regimen</p><br/><p>Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>3 weekly treatment regimen</p><br/><p>Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10257_10257_R","Continuing first-line treatment of metastatic disease, as monotherapy, where concomitant bevacizumab has ceased due to intolerance - 4 weekly treatment regimen","STREAMLINED","10257","10257","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing first-line treatment of metastatic disease, as monotherapy, where concomitant bevacizumab has ceased due to intolerance - 4 weekly treatment regimen</p><br/><p>Patient must have experienced intolerance to combination treatment with bevacizumab; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND</p> <p>Patient must have stable or responding disease; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing first-line treatment of metastatic disease, as monotherapy, where concomitant bevacizumab has ceased due to intolerance - 4 weekly treatment regimen</p><br/><p>Patient must have experienced intolerance to combination treatment with bevacizumab; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND</p> <p>Patient must have stable or responding disease; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10258_10215_R","Continuing treatment - 4 weekly treatment regimen","STREAMLINED","10215","10258","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Continuing treatment - 4 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have stable or responding disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Continuing treatment - 4 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have stable or responding disease.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10267_10268_R","null","AUTHORITY_REQUIRED","10268","10267","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 16 weeks.</p> <p align=""justify""><br/>The application must include details of the prior treatment regimen containing an NS5A inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 16 weeks.</p> <p align=""justify""><br/>The application must include details of the prior treatment regimen containing an NS5A inhibitor.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p align=""justify"">Special Pricing Arrangements apply.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10270_10271_R","Initial treatment","STREAMLINED","10271","10270","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; or</p> <p>Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND</p> <p>Patient must have a WHO performance status of 2 or less.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; or</p> <p>Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND</p> <p>Patient must have a WHO performance status of 2 or less.</p> <p/><p align=""justify"">A patient who has had progressive disease when treated with another BRAF inhibitor is not eligible to receive PBS-subsidised treatment with this drug.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10277_10216_R","Continuing first-line treatment of metastatic disease - 3 weekly treatment regimen","STREAMLINED","10216","10277","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing first-line treatment of metastatic disease - 3 weekly treatment regimen</p><br/><p>Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND</p> <p>Patient must have stable or responding disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing first-line treatment of metastatic disease - 3 weekly treatment regimen</p><br/><p>Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND</p> <p>Patient must have stable or responding disease.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10288_10250_R","Initial treatment","AUTHORITY_REQUIRED","10250","10288","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Autosomal dominant polycystic kidney disease (ADPKD)</p><br/><p>Initial treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have an estimated glomerular filtration rate (eGFR) between 30 and 89 mL/min 1.73 m2 at the initiation of treatment with this drug for this condition; AND</p> <p>Patient must have or have had rapidly progressing disease at the time of initiation of this drug for this condition.</p> <p align=""justify"">Rapidly progressing disease is defined as either of the following:</p><p align=""justify"">A decline in eGFR of greater than or equal to 5 mL/min/1.73 m<sup>2</sup> within one year;</p><p align=""justify"">OR</p><p align=""justify"">An average decline in eGFR of greater than or equal to 2.5 mL/min/1.73 m<sup>2</sup> per year over a five year period.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Autosomal dominant polycystic kidney disease (ADPKD)</p><br/><p>Initial treatment</p><br/><p>Must be treated by a nephrologist; AND</p> <p>Patient must have an estimated glomerular filtration rate (eGFR) between 30 and 89 mL/min 1.73 m2 at the initiation of treatment with this drug for this condition; AND</p> <p>Patient must have or have had rapidly progressing disease at the time of initiation of this drug for this condition.</p> <p align=""justify"">Rapidly progressing disease is defined as either of the following:</p><p align=""justify"">A decline in eGFR of greater than or equal to 5 mL/min/1.73 m<sup>2</sup> within one year;</p><p align=""justify"">OR</p><p align=""justify"">An average decline in eGFR of greater than or equal to 2.5 mL/min/1.73 m<sup>2</sup> per year over a five year period.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10289_10328_R","Initial treatment","STREAMLINED","10328","10289","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10292_10213_R","Continuing treatment (weekly regimen)","STREAMLINED","10213","10292","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Continuing treatment (weekly regimen)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Continuing treatment (weekly regimen)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10307_10324_R","Initial treatment","STREAMLINED","10324","10307","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner; AND</p> <p>Patient must be antiretroviral treatment naive; or</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen; AND</p> <p>The treatment must not be in combination with ritonavir.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner; AND</p> <p>Patient must be antiretroviral treatment naive; or</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen; AND</p> <p>The treatment must not be in combination with ritonavir.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p> <p align=""justify"">The cobicistat component of the darunavir + cobicistat combination product provides the necessary pharmacokinetic enhancement of darunavir to achieve therapeutic levels of darunavir.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10311_10294_R","Continuing treatment (3 weekly regimen)","STREAMLINED","10294","10311","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Continuing treatment (3 weekly regimen)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Continuing treatment (3 weekly regimen)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10318_10297_R","Continuing treatment - 3 weekly treatment regimen","STREAMLINED","10297","10318","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have stable or responding disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have stable or responding disease.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10323_6890_R","null","RESTRICTED","6890","10323","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a source of medium chain triglycerides</p><br/><p>Patient must have fat malabsorption due to liver disease; or</p> <p>Patient must have fat malabsorption due to short gut syndrome; or</p> <p>Patient must have fat malabsorption due to cystic fibrosis; or</p> <p>Patient must have fat malabsorption due to gastrointestinal disorders; AND</p> <p>Patient must be aged from 1 to 10 years inclusive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a source of medium chain triglycerides</p><br/><p>Patient must have fat malabsorption due to liver disease; or</p> <p>Patient must have fat malabsorption due to short gut syndrome; or</p> <p>Patient must have fat malabsorption due to cystic fibrosis; or</p> <p>Patient must have fat malabsorption due to gastrointestinal disorders; AND</p> <p>Patient must be aged from 1 to 10 years inclusive.</p> <p align=""justify"">Not indicated for the treatment of intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect requiring a ketogenic diet. </p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10329_10317_R","Continuing treatment","STREAMLINED","10317","10329","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner; AND</p> <p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must not be in combination with ritonavir.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner; AND</p> <p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must not be in combination with ritonavir.</p> <p align=""justify"">The cobicistat component of the darunavir + cobicistat combination product provides the necessary pharmacokinetic enhancement of darunavir to achieve therapeutic levels of darunavir.</p>","N","N","N","IMMEDIATE","ALL","N","2020-04-01","N","4708"
"10333_N","null","null","null","null","null","<p/><p align=""justify"">Denosumab is not PBS-subsidised for use in patients who have undergone curative surgical resection.</p><p/>","Y","N","N","null","null","N","2014-04-01","N","4708"
"10352_10362_R","null","STREAMLINED","10362","10352","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must be in the third trimester of pregnancy; AND</p> <p>Patient must have elevated HBV DNA levels greater than 200,000 IU/mL (1,000,000 copies/mL), in conjunction with documented hepatitis B infection.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must be in the third trimester of pregnancy; AND</p> <p>Patient must have elevated HBV DNA levels greater than 200,000 IU/mL (1,000,000 copies/mL), in conjunction with documented hepatitis B infection.</p> <p align=""justify"">Treatment is intended to prevent mother-to-child transmission of hepatitis B in the third trimester of pregnancy and to reduce the risk of viral reactivation in the mother up to 12 weeks post-partum.</p>","N","N","N","IMMEDIATE","ALL","N","2020-05-01","N","4708"
"10353_10363_R","null","STREAMLINED","10363","10353","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic; AND</p> <p>Patient must require continuous administration of levodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2000 mg of levodopa.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic; AND</p> <p>Patient must require continuous administration of levodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2000 mg of levodopa.</p> <p align=""justify"">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p>","N","N","N","IMMEDIATE","ALL","N","2020-05-01","N","4708"
"10365_10355_R","Continuing treatment","AUTHORITY_REQUIRED","10355","10365","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p>","N","N","N","IMMEDIATE","ALL","N","2020-05-01","N","4708"
"10370_N","null","null","null","null","null","<p/><p align=""justify"">In first-line usage, effectiveness and tolerance may be improved when irinotecan is combined with an infusional 5-fluorouracil regimen. </p><p/>","Y","N","N","null","null","N","2014-04-01","N","4708"
"10381_10390_R","Continuing treatment","AUTHORITY_REQUIRED","10390","10381","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p>","N","N","N","IMMEDIATE","ALL","N","2020-05-01","N","4708"
"10395_10375_R","null","STREAMLINED","10375","10395","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic; AND</p> <p>Patient must require continuous administration of levodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2000 mg of levodopa.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>The treatment must be commenced in a hospital-based movement disorder clinic; AND</p> <p>Patient must require continuous administration of levodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2000 mg of levodopa.</p> <p align=""justify"">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p>","N","N","N","IMMEDIATE","ALL","N","2020-05-01","N","4708"
"10396_10391_R","Initial treatment","AUTHORITY_REQUIRED","10391","10396","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency</p><br/><p>Initial treatment</p><br/><p>Must be treated by a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.</p> <p align=""justify"">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency</p><br/><p>Initial treatment</p><br/><p>Must be treated by a metabolic physician; AND</p> <p>Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.</p> <p align=""justify"">Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.</p> <p align=""justify"">Patient will be eligible for a maximum of one PBS-subsidised prescription as initial therapy to enable their response to treatment with sapropterin to be assessed.</p>","N","N","N","IMMEDIATE","ALL","N","2020-05-01","N","4708"
"10401_10410_R","null","STREAMLINED","10410","10401","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have a pin-site infection; or</p> <p>Patient must have an infection following cardiac device insertion; or</p> <p>Patient must have acute otitis externa; or</p> <p>Patient must have streptococcal pharyngitis or tonsillitis; or</p> <p>Patient must have mastitis; or</p> <p>Patient must have periorbital (preseptal) cellulitis; or</p> <p>Patient must have acute rheumatic fever; or</p> <p>Patient must have a diabetic foot infection; or</p> <p>Patient must have a widespread infection of dermatitis; or</p> <p>Patient must require treatment for prophylaxis for invasive group A streptococcal (iGAS) infection; or</p> <p>Patient must have impetigo; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> <p align=""justify"">Midwives may prescribe under this item for the treatment of mastitis only.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have a pin-site infection; or</p> <p>Patient must have an infection following cardiac device insertion; or</p> <p>Patient must have acute otitis externa; or</p> <p>Patient must have streptococcal pharyngitis or tonsillitis; or</p> <p>Patient must have mastitis; or</p> <p>Patient must have periorbital (preseptal) cellulitis; or</p> <p>Patient must have acute rheumatic fever; or</p> <p>Patient must have a diabetic foot infection; or</p> <p>Patient must have a widespread infection of dermatitis; or</p> <p>Patient must require treatment for prophylaxis for invasive group A streptococcal (iGAS) infection; or</p> <p>Patient must have impetigo; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> <p align=""justify"">Midwives may prescribe under this item for the treatment of mastitis only.</p>","N","N","N","IMMEDIATE","ALL","N","2020-05-01","N","4708"
"10404_10404_R","null","STREAMLINED","10404","10404","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2020-05-01","N","4708"
"10406_10402_R","null","STREAMLINED","10402","10406","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must be a male with acute cystitis; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have a tooth avulsion; or</p> <p>Patient must have salmonella enteritis; or</p> <p>Patient must have community acquired pneumonia; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must be a male with acute cystitis; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have a tooth avulsion; or</p> <p>Patient must have salmonella enteritis; or</p> <p>Patient must have community acquired pneumonia; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2020-05-01","N","4708"
"10408_10405_R","null","STREAMLINED","10405","10408","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must be a male with acute cystitis; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must be a male with acute cystitis; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2020-05-01","N","4708"
"10409_10412_R","null","STREAMLINED","10412","10409","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have impaired renal function; AND</p> <p>Patient must have a pin-site infection; or</p> <p>Patient must have an infection following cardiac device insertion; or</p> <p>Patient must have acute otitis externa; or</p> <p>Patient must have streptococcal pharyngitis or tonsillitis; or</p> <p>Patient must have mastitis; or</p> <p>Patient must have periorbital (preseptal) cellulitis; or</p> <p>Patient must have acute rheumatic fever; or</p> <p>Patient must have a diabetic foot infection; or</p> <p>Patient must have a widespread infection of dermatitis; or</p> <p>Patient must require treatment for prophylaxis for invasive group A streptococcal (iGAS) infection; or</p> <p>Patient must have impetigo; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> <p align=""justify"">Midwives may prescribe under this item for the treatment of mastitis only, where the patient has impaired renal function.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have impaired renal function; AND</p> <p>Patient must have a pin-site infection; or</p> <p>Patient must have an infection following cardiac device insertion; or</p> <p>Patient must have acute otitis externa; or</p> <p>Patient must have streptococcal pharyngitis or tonsillitis; or</p> <p>Patient must have mastitis; or</p> <p>Patient must have periorbital (preseptal) cellulitis; or</p> <p>Patient must have acute rheumatic fever; or</p> <p>Patient must have a diabetic foot infection; or</p> <p>Patient must have a widespread infection of dermatitis; or</p> <p>Patient must require treatment for prophylaxis for invasive group A streptococcal (iGAS) infection; or</p> <p>Patient must have impetigo; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p> <p align=""justify"">Midwives may prescribe under this item for the treatment of mastitis only, where the patient has impaired renal function.</p>","N","N","N","IMMEDIATE","ALL","N","2020-05-01","N","4708"
"10411_10413_R","null","STREAMLINED","10413","10411","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have periorbital (preseptal) cellulitis; or</p> <p>Patient must have postpartum endometritis; or</p> <p>Patient must have an exacerbation of bronchiectasis; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have pneumonia acquired in hospital or aged care; or</p> <p>Patient must have a diabetic foot infection; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>Patient must have periorbital (preseptal) cellulitis; or</p> <p>Patient must have postpartum endometritis; or</p> <p>Patient must have an exacerbation of bronchiectasis; or</p> <p>Patient must have pyelonephritis; or</p> <p>Patient must have pneumonia acquired in hospital or aged care; or</p> <p>Patient must have a diabetic foot infection; or</p> <p>Patient must have a condition requiring prolonged oral antibiotic therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2020-05-01","N","4708"
"10416_10416_R","null","STREAMLINED","10416","10416","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Community acquired pneumonia</p><br/><p>Patient must have community acquired pneumonia.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Community acquired pneumonia</p><br/><p>Patient must have community acquired pneumonia.</p>","N","N","N","IMMEDIATE","ALL","N","2020-05-01","N","4708"
"10430_10431_R","Continuing treatment","AUTHORITY_REQUIRED","10431","10430","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2020-06-01","N","4708"
"10437_10482_R","null","STREAMLINED","10482","10437","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild asthma</p><br/><p>Patient must have asthma and require an anti-inflammatory reliever therapy; AND</p> <p>Patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA); AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild asthma</p><br/><p>Patient must have asthma and require an anti-inflammatory reliever therapy; AND</p> <p>Patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA); AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.</p> <p align=""left"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD) or for allergen-induced or exercise-induced bronchoconstriction in the absence of asthma.</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p>","N","N","N","IMMEDIATE","ALL","N","2020-06-01","N","4708"
"10463_10464_R","null","STREAMLINED","10464","10463","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild asthma</p><br/><p>Patient must have asthma and require an anti-inflammatory reliever therapy; AND</p> <p>Patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA).</p> <p align=""justify"">Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild asthma</p><br/><p>Patient must have asthma and require an anti-inflammatory reliever therapy; AND</p> <p>Patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA).</p> <p align=""justify"">Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.</p> <p align=""left"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD) or for allergen-induced or exercise-induced bronchoconstriction in the absence of asthma.</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p>","N","N","N","IMMEDIATE","ALL","N","2020-06-01","N","4708"
"10496_10521_R","Continuing treatment - 3 weekly treatment regimen","STREAMLINED","10521","10496","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Extensive-stage small cell lung cancer</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Extensive-stage small cell lung cancer</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2020-07-01","N","4708"
"10504_10499_R","null","AUTHORITY_REQUIRED","10499","10504","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>Patient must have lower urinary tract symptoms.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>Patient must have lower urinary tract symptoms.</p>","N","N","N","IMMEDIATE","ALL","N","2020-07-01","N","4708"
"10505_10498_R","null","STREAMLINED","10498","10505","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with radiotherapy being used to treat malignancy; or</p> <p>The condition must be associated with oral chemotherapy being used to treat malignancy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with radiotherapy being used to treat malignancy; or</p> <p>The condition must be associated with oral chemotherapy being used to treat malignancy.</p>","N","N","N","IMMEDIATE","ALL","N","2020-07-01","N","4708"
"10509_10509_R","Continuing treatment - 4 weekly treatment regimen","STREAMLINED","10509","10509","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Extensive-stage small cell lung cancer</p><br/><p>Continuing treatment - 4 weekly treatment regimen</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Extensive-stage small cell lung cancer</p><br/><p>Continuing treatment - 4 weekly treatment regimen</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2020-07-01","N","4708"
"10518_10459_R","Initial 1 (New patient), Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","10459","10518","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial 1 (New patient), Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 18 to 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 18 to 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial 1 (New patient), Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 18 to 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 18 to 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2020-07-01","N","4708"
"10531_9547_R","null","STREAMLINED","9547","10531","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe spasticity of the upper limb following an acute event</p><br/><p>The condition must be moderate to severe spasticity of the upper limb/s following an acute event, defined as a Modified Ashworth Scale rating of 3 or more; AND</p> <p>The treatment must only be used as second line therapy when standard management has failed; or</p> <p>The treatment must only be used as an adjunct to physical therapy; AND</p> <p>The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND</p> <p>The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per upper limb in the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per upper limb each year thereafter; AND</p> <p>Patient must not have established severe contracture in the limb to be treated; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a plastic surgeon; or</p> <p>Must be treated by a geriatrician.</p> <p align=""justify"">Standard management includes physiotherapy and/or oral spasticity agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe spasticity of the upper limb following an acute event</p><br/><p>The condition must be moderate to severe spasticity of the upper limb/s following an acute event, defined as a Modified Ashworth Scale rating of 3 or more; AND</p> <p>The treatment must only be used as second line therapy when standard management has failed; or</p> <p>The treatment must only be used as an adjunct to physical therapy; AND</p> <p>The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND</p> <p>The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per upper limb in the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per upper limb each year thereafter; AND</p> <p>Patient must not have established severe contracture in the limb to be treated; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a plastic surgeon; or</p> <p>Must be treated by a geriatrician.</p> <p align=""justify"">Standard management includes physiotherapy and/or oral spasticity agents.</p>","N","N","N","IMMEDIATE","ALL","N","2020-08-01","N","4708"
"10574_10538_R","null","STREAMLINED","10538","10574","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition; AND</p> <p>Must be treated by a respiratory physician; or</p> <p>Must be treated by a paediatrician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition; AND</p> <p>Must be treated by a respiratory physician; or</p> <p>Must be treated by a paediatrician.</p>","N","N","N","IMMEDIATE","ALL","N","2020-08-01","N","4708"
"10589_5937_R","Episodic treatment","STREAMLINED","5937","10589","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> <p align=""justify"">Famciclovir 125 mg is not PBS-subsidised for chickenpox, herpes zoster or herpes simplex infections other than genital herpes.</p>","N","N","N","IMMEDIATE","ALL","N","2020-08-01","N","4708"
"10604_10434_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","10434","10604","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p>","N","N","N","IMMEDIATE","ALL","N","2020-08-01","N","4708"
"10615_N","null","null","null","null","null","<p align=""justify"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p>","Y","N","N","null","null","N","2014-12-01","N","4708"
"10622_9601_R","Consolidation treatment","AUTHORITY_REQUIRED","9601","10622","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Consolidation treatment</p><br/><p>Patient must have previously received PBS-subsidised induction treatment with this drug for this condition; AND</p> <p>Patient must have achieved a complete remission; or</p> <p>Patient must have achieved a complete remission with partial haematological recovery; AND</p> <p>The treatment must not be more than 5 treatment cycles under this restriction in a lifetime; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">The treatment must not exceed 0.5mg per m<sup>2</sup> for all doses within a treatment cycle</p> <p align=""justify"">Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Careful monitoring of patients is required due to risk of developing hepatotoxicity, including life-threatening hepatic veno-occlusive disease, and the increased risk of post-haematopoietic stem cell transplant non-relapse mortality observed in patients treated with inotuzumab.</p> <p>Acute lymphoblastic leukaemia</p><br/><p>Consolidation treatment</p><br/><p>Patient must have previously received PBS-subsidised induction treatment with this drug for this condition; AND</p> <p>Patient must have achieved a complete remission; or</p> <p>Patient must have achieved a complete remission with partial haematological recovery; AND</p> <p>The treatment must not be more than 5 treatment cycles under this restriction in a lifetime; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">The treatment must not exceed 0.5mg per m<sup>2</sup> for all doses within a treatment cycle</p> <p align=""justify"">Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.</p> <p align=""justify"">A complete remission is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a full recovery of peripheral blood counts with platelets of greater than 100,000 per microliter, and absolute neutrophil count (ANC) of greater than 1,000 per microliter.</p> <p align=""justify"">A complete remission with partial haematological recovery is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a partial recovery of peripheral blood counts with platelets of greater than 50,000 per microliter, and absolute neutrophil count (ANC) of greater than 500 per microliter.</p> <p align=""justify"">Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time when an assessment is required must cease PBS-subsidised therapy with this agent.</p>","N","N","N","IMMEDIATE","ALL","N","2020-08-01","N","4708"
"10623_5937_R","Episodic treatment","STREAMLINED","5937","10623","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> <p align=""justify"">Famciclovir 250 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.</p>","N","N","N","IMMEDIATE","ALL","N","2020-08-01","N","4708"
"10676_10676_R","Continuing treatment - 6 weekly treatment regimen","AUTHORITY_REQUIRED","10676","10676","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Continuing treatment - 6 weekly treatment regimen</p><br/><p>Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Continuing treatment - 6 weekly treatment regimen</p><br/><p>Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2020-09-01","N","4708"
"10680_10705_R","Continuing treatment - 3 weekly treatment regimen","STREAMLINED","10705","10680","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease.</p>","N","N","N","IMMEDIATE","ALL","N","2020-09-01","N","4708"
"10700_10688_R","Initial treatment - 6 weekly treatment regimen","AUTHORITY_REQUIRED","10688","10700","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Initial treatment - 6 weekly treatment regimen</p><br/><p>The treatment must be adjuvant to complete surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Initial treatment - 6 weekly treatment regimen</p><br/><p>The treatment must be adjuvant to complete surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> <p align=""justify"">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p>","N","N","N","IMMEDIATE","ALL","N","2020-09-01","N","4708"
"10706_10701_R","Continuing treatment - 6 weekly treatment regimen","STREAMLINED","10701","10706","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment - 6 weekly treatment regimen</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment - 6 weekly treatment regimen</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease.</p>","N","N","N","IMMEDIATE","ALL","N","2020-09-01","N","4708"
"10720_10844_R","Maintenance therapy","STREAMLINED","10844","10720","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>Patient must have been commenced on treatment in a specialist unit in a hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>Patient must have been commenced on treatment in a specialist unit in a hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2020-10-01","N","4708"
"10728_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form sumatriptan tablet 50 mg (as succinate) and pharmaceutical benefits that have the form sumatriptan tablet (fast disintegrating) 50 mg (as succinate) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2014-07-01","N","4708"
"10734_7046_R","Continuing treatment","AUTHORITY_REQUIRED","7046","10734","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spontaneous urticaria</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist; or</p> <p>Must be treated by an allergist; or</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU); AND</p> <p>Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks per authorised course of treatment under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spontaneous urticaria</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist; or</p> <p>Must be treated by an allergist; or</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU); AND</p> <p>Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks per authorised course of treatment under this restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2020-10-01","N","4708"
"10749_10755_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months","STREAMLINED","10755","10749","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10750_10748_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months","STREAMLINED","10748","10750","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(ii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iii) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(ii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iii) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10752_10752_R","Continuing PBS treatment after 1 June 2020","STREAMLINED","10752","10752","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) is less than 12 months; or</p><p align=""justify"">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) is less than 12 months; or</p><p align=""justify"">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10757_10758_R","null","RESTRICTED","10758","10757","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>The treatment must be for short term therapy of acute severe pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>The treatment must be for short term therapy of acute severe pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p>","N","N","N","IMMEDIATE","ALL","N","2020-10-01","N","4708"
"10759_10839_R","null","RESTRICTED","10839","10759","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; or</p> <p>The treatment must be part of pre-operative care; or</p> <p>The treatment must be used as an analgesic adjunct in general anaesthesia.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; or</p> <p>The treatment must be part of pre-operative care; or</p> <p>The treatment must be used as an analgesic adjunct in general anaesthesia.</p>","N","N","N","IMMEDIATE","ALL","N","2020-10-01","N","4708"
"10760_10766_R","null","RESTRICTED","10766","10760","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>The treatment must be for short term therapy of acute severe pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>The treatment must be for short term therapy of acute severe pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p>","N","N","N","IMMEDIATE","ALL","N","2020-10-01","N","4708"
"10761_10772_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months","RESTRICTED","10772","10761","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align=""justify"">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align=""justify"">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align=""justify"">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align=""justify"">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10763_10777_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months","RESTRICTED","10777","10763","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10764_10764_R","Continuing PBS treatment after 1 June 2020","RESTRICTED","10764","10764","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered where the patient has received initial authority approval for:</p><p align=""justify"">(i) severe disabling pain associated with malignant neoplasia; or</p><p align=""justify"">(ii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months; or</p><p align=""justify"">(iii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(v) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered where the patient has received initial authority approval for:</p><p align=""justify"">(i) severe disabling pain associated with malignant neoplasia; or</p><p align=""justify"">(ii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months; or</p><p align=""justify"">(iii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(v) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10767_10768_R","null","RESTRICTED","10768","10767","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p>","N","N","N","IMMEDIATE","ALL","N","2020-10-01","N","4708"
"10769_10765_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months","RESTRICTED","10765","10769","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; or</p> <p>The treatment must be part of pre-operative care; or</p> <p>The treatment must be used as an analgesic adjunct in general anaesthesia.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; or</p> <p>The treatment must be part of pre-operative care; or</p> <p>The treatment must be used as an analgesic adjunct in general anaesthesia.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10773_10771_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months","RESTRICTED","10771","10773","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10774_10891_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months","RESTRICTED","10891","10774","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cancer pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have cancer pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cancer pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>Patient must have cancer pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10775_10775_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months","RESTRICTED","10775","10775","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cancer pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have cancer pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align=""justify"">(i) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(ii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cancer pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have cancer pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align=""justify"">(i) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(ii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10776_10770_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months","RESTRICTED","10770","10776","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align=""justify"">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align=""justify"">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align=""justify"">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align=""justify"">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10793_10830_R","null","STREAMLINED","10830","10793","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2020-10-01","N","4708"
"10814_10814_R","Continuing PBS treatment after 1 June 2020","AUTHORITY_REQUIRED","10814","10814","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) is less than 12 months; or</p><p align=""justify"">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) is less than 12 months; or</p><p align=""justify"">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10815_10859_R","null","RESTRICTED","10859","10815","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.</p>","N","N","N","IMMEDIATE","ALL","N","2020-10-01","N","4708"
"10816_10762_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months","RESTRICTED","10762","10816","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; or</p> <p>The treatment must be part of pre-operative care; or</p> <p>The treatment must be used as an analgesic adjunct in general anaesthesia.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align=""justify"">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align=""justify"">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; or</p> <p>The treatment must be part of pre-operative care; or</p> <p>The treatment must be used as an analgesic adjunct in general anaesthesia.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for:</p><p align=""justify"">(i) severe disabling pain associated with proven malignant neoplasia; or</p><p align=""justify"">(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10835_10756_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months","AUTHORITY_REQUIRED","10756","10835","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10837_10837_R","Continuing PBS treatment after 1 June 2020","RESTRICTED","10837","10837","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cancer pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) is less than 12 months; or</p><p align=""justify"">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cancer pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) is less than 12 months; or</p><p align=""justify"">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10858_10858_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months","AUTHORITY_REQUIRED","10858","10858","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(ii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iii) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(ii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iii) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2020-10-01","N","4708"
"10864_10863_R","null","STREAMLINED","10863","10864","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2020-10-01","N","4708"
"10877_10836_R","null","AUTHORITY_REQUIRED","10836","10877","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.</p>","N","N","N","IMMEDIATE","ALL","N","2020-10-01","N","4708"
"10909_N","null","null","null","null","null","<p>OxyContin modified release tablets are intended to be crush-deterrent and to reduce the rapid release of oxycodone upon accidental or intentional misuse.</p>","Y","N","N","null","null","N","2014-08-01","N","4708"
"10917_10917_R","Continuing treatment of hepatocellular carcinoma - 3 weekly treatment regimen","STREAMLINED","10917","10917","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment of hepatocellular carcinoma - 3 weekly treatment regimen</p><br/><p>Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p> <p align=""justify"">PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment of hepatocellular carcinoma - 3 weekly treatment regimen</p><br/><p>Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p> <p align=""justify"">PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time</p>","N","N","N","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10919_6137_R","Initial treatment for up to 6 months","STREAMLINED","6137","10919","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p align=""justify"">The name of the specialist must be documented in the patient&apos;s medical records</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p align=""justify"">The name of the specialist must be documented in the patient&apos;s medical records</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10923_6182_R","Continuing treatment","STREAMLINED","6182","10923","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p align=""justify"">The name of the specialist must be documented in the patient&apos;s medical records</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p align=""justify"">The name of the specialist must be documented in the patient&apos;s medical records</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10934_10968_R","Continuing or change of treatment","AUTHORITY_REQUIRED","10968","10934","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Continuing or change of treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with armodafinil for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Continuing or change of treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with armodafinil for this condition.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10936_10935_R","Initial 2 - treatment of narcolepsy with cataplexy","AUTHORITY_REQUIRED","10935","10936","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Initial 2 - treatment of narcolepsy with cataplexy</p><br/><p>Must be treated by a qualified sleep medicine practitioner or neurologist; AND</p> <p>The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; or</p> <p>The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND</p> <p>Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND</p> <p>Patient must have a definite history of cataplexy documented in their medical records for auditing purposes; AND</p> <p>Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.</p> <p align=""justify"">The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:</p><p align=""justify"">(a) a psychiatric disorder;</p><p align=""justify"">(b) a cardiovascular disorder;</p><p align=""justify"">(c) a history of substance abuse;</p><p align=""justify"">(d) glaucoma;</p><p align=""justify"">(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Initial 2 - treatment of narcolepsy with cataplexy</p><br/><p>Must be treated by a qualified sleep medicine practitioner or neurologist; AND</p> <p>The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; or</p> <p>The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND</p> <p>Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND</p> <p>Patient must have a definite history of cataplexy documented in their medical records for auditing purposes; AND</p> <p>Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.</p> <p align=""justify"">The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:</p><p align=""justify"">(a) a psychiatric disorder;</p><p align=""justify"">(b) a cardiovascular disorder;</p><p align=""justify"">(c) a history of substance abuse;</p><p align=""justify"">(d) glaucoma;</p><p align=""justify"">(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10939_10939_R","Initial treatment","STREAMLINED","10939","10939","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must not be suitable for transarterial chemoembolisation; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must not be suitable for transarterial chemoembolisation; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal.</p>","N","N","N","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10941_6148_R","null","STREAMLINED","6148","10941","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe diarrhoea of greater than 2 weeks duration</p><br/><p>Patient must be aged less than 4 months.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe diarrhoea of greater than 2 weeks duration</p><br/><p>Patient must be aged less than 4 months.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10949_10970_R","Initial 1 - treatment of narcolepsy without cataplexy","AUTHORITY_REQUIRED","10970","10949","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Initial 1 - treatment of narcolepsy without cataplexy</p><br/><p>Must be treated by a qualified sleep medicine practitioner or neurologist; AND</p> <p>The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; or</p> <p>The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND</p> <p>Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND</p> <p>Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); or</p> <p>Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; AND</p> <p>Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.</p> <p align=""justify"">The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:</p><p align=""justify"">(a) a psychiatric disorder;</p><p align=""justify"">(b) a cardiovascular disorder;</p><p align=""justify"">(c) a history of substance abuse;</p><p align=""justify"">(d) glaucoma;</p><p align=""justify"">(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.</p> <p align=""left"">The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration.</p> <p align=""justify"">The authority application must be made in writing and must include the following:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and</p><p align=""justify"">(c) details of the contraindication or intolerance to dexamfetamine sulfate; and</p><p align=""justify"">(d) either:</p><p align=""justify"">(i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or</p><p align=""justify"">(ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist.</p><p align=""justify"">The polysomnography, MSLT or EEG test reports must be provided with the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Initial 1 - treatment of narcolepsy without cataplexy</p><br/><p>Must be treated by a qualified sleep medicine practitioner or neurologist; AND</p> <p>The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; or</p> <p>The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND</p> <p>Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND</p> <p>Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); or</p> <p>Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; AND</p> <p>Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.</p> <p align=""justify"">The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:</p><p align=""justify"">(a) a psychiatric disorder;</p><p align=""justify"">(b) a cardiovascular disorder;</p><p align=""justify"">(c) a history of substance abuse;</p><p align=""justify"">(d) glaucoma;</p><p align=""justify"">(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.</p> <p align=""left"">The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration.</p> <p align=""justify"">The authority application must be made in writing and must include the following:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and</p><p align=""justify"">(c) details of the contraindication or intolerance to dexamfetamine sulfate; and</p><p align=""justify"">(d) either:</p><p align=""justify"">(i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or</p><p align=""justify"">(ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist.</p><p align=""justify"">The polysomnography, MSLT or EEG test reports must be provided with the authority application.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2020-11-01","Y","4708"
"10950_10988_R","Continuing treatment","STREAMLINED","10988","10950","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist.</p> <p align=""justify"">A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist.</p> <p align=""justify"">A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment</p>","N","N","N","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10951_10985_R","Initial treatment","STREAMLINED","10985","10951","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist; AND</p> <p>Patient must be aged 18 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist; AND</p> <p>Patient must be aged 18 years or over.</p>","N","N","N","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10961_6174_R","Initial treatment","STREAMLINED","6174","10961","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy and intolerance to soy protein</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have failed to respond to a strict soy-based cows'' milk protein free diet; AND</p> <p>Patient must be up to the age of 24 months.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy and intolerance to soy protein</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have failed to respond to a strict soy-based cows'' milk protein free diet; AND</p> <p>Patient must be up to the age of 24 months.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10969_10967_R","Continuing or change of treatment","AUTHORITY_REQUIRED","10967","10969","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Continuing or change of treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with modafinil for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Continuing or change of treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with modafinil for this condition.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10971_10971_R","Initial treatment","STREAMLINED","10971","10971","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist; AND</p> <p>Patient must be aged 18 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist; AND</p> <p>Patient must be aged 18 years or over.</p>","N","N","N","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10972_10972_R","Continuing treatment where bevacizumab is discontinued - 4 weekly treatment regimen","STREAMLINED","10972","10972","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment where bevacizumab is discontinued - 4 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p> <p align=""justify"">PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment where bevacizumab is discontinued - 4 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p> <p align=""justify"">PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time</p>","N","N","N","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10982_6204_R","null","STREAMLINED","6204","10982","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy and intolerance to soy protein</p><br/><p>Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have failed to respond to a strict soy-based cows'' milk protein free diet; AND</p> <p>Patient must be older than 24 months of age.</p> <p align=""justify"">The name of the specialist must be documented in the patient&apos;s medical records</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy and intolerance to soy protein</p><br/><p>Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have failed to respond to a strict soy-based cows'' milk protein free diet; AND</p> <p>Patient must be older than 24 months of age.</p> <p align=""justify"">The name of the specialist must be documented in the patient&apos;s medical records</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10986_6193_R","Continuing treatment","STREAMLINED","6193","10986","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy and intolerance to soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have demonstrated a clinical improvement with the protein hydrolysate formula with medium chain triglycerides; AND</p> <p>Patient must be up to the age of 24 months.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy and intolerance to soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have demonstrated a clinical improvement with the protein hydrolysate formula with medium chain triglycerides; AND</p> <p>Patient must be up to the age of 24 months.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10989_10989_R","Continuing treatment","STREAMLINED","10989","10989","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist.</p> <p align=""justify"">A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or</p> <p>The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND</p> <p>Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist.</p> <p align=""justify"">A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment</p>","N","N","N","IMMEDIATE","ALL","N","2020-11-01","N","4708"
"10994_10995_R","Dose modification","AUTHORITY_REQUIRED","10995","10994","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Dose modification</p><br/><p>The treatment must be for dose titration purposes.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Dose modification</p><br/><p>The treatment must be for dose titration purposes.</p>","N","N","N","IMMEDIATE","ALL","N","2020-12-01","N","4708"
"11011_C","null","null","null","null","null","<p>This is a category X drug and must not be given to pregnant women. Pregnancy must be avoided during treatment and for at least 3 months following cessation of therapy.</p>","N","Y","N","null","null","N","2014-09-01","N","4708"
"11013_11013_R","Initial treatment","STREAMLINED","11013","11013","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic stable atherosclerotic disease</p><br/><p>Initial treatment</p><br/><p>The treatment must be in combination with aspirin, but not with any other anti-platelet therapy; AND</p> <p>Patient must have a diagnosis of coronary artery disease in addition to at least one of the following risk factors: (i) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (ii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iii) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; or</p> <p>Patient must have a diagnosis of peripheral artery disease in addition to at least one of the following risk factors: (i) concomitant coronary artery disease (ii) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (iii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iv) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; AND</p> <p>Patient must have at least one of the following if coronary artery disease is present: (i) a previous multi-vessel coronary revascularisation procedure (ii) significant stenosis in at least 2 coronary arteries (iii) a previous single vessel coronary revascularisation procedure with significant stenosis in more than 1 coronary artery; or</p> <p>Patient must have at least one of the following if peripheral arterial disease is present: (i) a previous peripheral/carotid artery revascularisation intervention (ii) intermittent claudication with an ankle-brachial index less than 0.9 (iii) asymptomatic carotid artery stenosis greater than 50%; AND</p> <p>The condition must be diagnosed by at least one of: (i) invasive (selective) angiography (ii) non-invasive imaging (i.e. CT scan, ultrasound) (iii) ankle-brachial index measurement in the case of peripheral arterial disease with intermittent claudication; AND</p> <p>Patient must have clinical findings/observations by the treating physician that exclude each of the following: (i) high risk of bleeding (ii) prior stroke within one month of treatment initiation (iii) prior haemorrhagic / lacunar stroke (iv) severe heart failure with a known ejection fraction less than 30% (v) New York Heart Association class III to IV heart failure symptoms (i.e. symptoms corresponding to moderate to severe limitation on physical activity, whereby any of fatigue/palpitations/dyspnoea occur upon zero to minimal activity) (vi) an estimated glomerular filtration rate less than 15 mL/minute (vii) a requirement for dual antiplatelet therapy (viii) a requirement for non-acetylsalicylic acid antiplatelet therapy (ix) a requirement for a higher dose of oral anticoagulant therapy; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by a physician who has consulted a specialist physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic stable atherosclerotic disease</p><br/><p>Initial treatment</p><br/><p>The treatment must be in combination with aspirin, but not with any other anti-platelet therapy; AND</p> <p>Patient must have a diagnosis of coronary artery disease in addition to at least one of the following risk factors: (i) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (ii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iii) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; or</p> <p>Patient must have a diagnosis of peripheral artery disease in addition to at least one of the following risk factors: (i) concomitant coronary artery disease (ii) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (iii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iv) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; AND</p> <p>Patient must have at least one of the following if coronary artery disease is present: (i) a previous multi-vessel coronary revascularisation procedure (ii) significant stenosis in at least 2 coronary arteries (iii) a previous single vessel coronary revascularisation procedure with significant stenosis in more than 1 coronary artery; or</p> <p>Patient must have at least one of the following if peripheral arterial disease is present: (i) a previous peripheral/carotid artery revascularisation intervention (ii) intermittent claudication with an ankle-brachial index less than 0.9 (iii) asymptomatic carotid artery stenosis greater than 50%; AND</p> <p>The condition must be diagnosed by at least one of: (i) invasive (selective) angiography (ii) non-invasive imaging (i.e. CT scan, ultrasound) (iii) ankle-brachial index measurement in the case of peripheral arterial disease with intermittent claudication; AND</p> <p>Patient must have clinical findings/observations by the treating physician that exclude each of the following: (i) high risk of bleeding (ii) prior stroke within one month of treatment initiation (iii) prior haemorrhagic / lacunar stroke (iv) severe heart failure with a known ejection fraction less than 30% (v) New York Heart Association class III to IV heart failure symptoms (i.e. symptoms corresponding to moderate to severe limitation on physical activity, whereby any of fatigue/palpitations/dyspnoea occur upon zero to minimal activity) (vi) an estimated glomerular filtration rate less than 15 mL/minute (vii) a requirement for dual antiplatelet therapy (viii) a requirement for non-acetylsalicylic acid antiplatelet therapy (ix) a requirement for a higher dose of oral anticoagulant therapy; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by a physician who has consulted a specialist physician.</p>","N","N","N","IMMEDIATE","ALL","N","2020-12-01","N","4708"
"11014_11057_R","null","STREAMLINED","11057","11014","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 18 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 18 years or older.</p>","N","N","N","IMMEDIATE","ALL","N","2020-12-01","N","4708"
"11047_11066_R","Continuing or change of treatment","STREAMLINED","11066","11047","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing or change of treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing or change of treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection.</p>","N","N","N","IMMEDIATE","ALL","N","2020-12-01","N","4708"
"11059_11070_R","null","STREAMLINED","11070","11059","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic renal failure</p><br/><p>Patient must be a child aged 3 years or older; AND</p> <p>Patient must require treatment with a low protein and a low phosphorus diet; or</p> <p>Patient must require treatment with a low protein, low phosphorus and low potassium diet.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic renal failure</p><br/><p>Patient must be a child aged 3 years or older; AND</p> <p>Patient must require treatment with a low protein and a low phosphorus diet; or</p> <p>Patient must require treatment with a low protein, low phosphorus and low potassium diet.</p>","N","N","N","IMMEDIATE","ALL","N","2020-12-01","N","4708"
"11068_11069_R","Continuing treatment","AUTHORITY_REQUIRED","11069","11068","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND</p> <p>The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment under this restriction with this drug for this condition, whichever comes first.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND</p> <p>The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment under this restriction with this drug for this condition, whichever comes first.</p>","N","N","N","IMMEDIATE","ALL","N","2020-12-01","N","4708"
"11099_11099_R","null","RESTRICTED","11099","11099","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p>","N","N","N","IMMEDIATE","ALL","N","2021-01-01","N","4708"
"11105_11143_R","null","RESTRICTED","11143","11105","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection</p><br/><p>Patient must have at least one of the following prior to having the latest PBS-subsidised prescription issued: (i) a negative HIV test result no older than 4 weeks, (ii) evidence that an HIV test has been conducted, but the result is still forthcoming.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection</p><br/><p>Patient must have at least one of the following prior to having the latest PBS-subsidised prescription issued: (i) a negative HIV test result no older than 4 weeks, (ii) evidence that an HIV test has been conducted, but the result is still forthcoming.</p>","N","N","N","IMMEDIATE","ALL","N","2021-01-01","N","4708"
"11110_8296_R","Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply","AUTHORITY_REQUIRED","8296","11110","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-01-01","N","4708"
"11173_11158_R","Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","11158","11173","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-01-01","N","4708"
"11192_11195_R","Initial treatment following dose titration","AUTHORITY_REQUIRED","11195","11192","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment following dose titration</p><br/><p>Patient must have WHO Functional Class III PAH at treatment initiation with this drug; or</p> <p>Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>Patient must have completed the dose titration phase; AND</p> <p>The treatment must not be as monotherapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.</p> <p align=""justify"">Select one appropriate strength (determined under the &apos;Initial treatment - dose titration&apos; phase) and apply under this treatment phase (Initial treatment following dose titration) once only. Should future dose adjustments be required, apply under the &apos;Continuing treatment&apos; restriction.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align=""justify"">PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) is defined as follows:</p><p align=""justify"">(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or</p><p align=""justify"">(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment following dose titration</p><br/><p>Patient must have WHO Functional Class III PAH at treatment initiation with this drug; or</p> <p>Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>Patient must have completed the dose titration phase; AND</p> <p>The treatment must not be as monotherapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.</p> <p align=""justify"">Select one appropriate strength (determined under the &apos;Initial treatment - dose titration&apos; phase) and apply under this treatment phase (Initial treatment following dose titration) once only. Should future dose adjustments be required, apply under the &apos;Continuing treatment&apos; restriction.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align=""justify"">PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) is defined as follows:</p><p align=""justify"">(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or</p><p align=""justify"">(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11193_11193_R","Continuing treatment","AUTHORITY_REQUIRED","11193","11193","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>The treatment must not be as monotherapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align=""justify"">For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred:</p><p align=""justify"">(i) Hospitalisation due to worsening PAH;</p><p align=""justify"">(ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with worsening of WHO functional class status;</p><p align=""justify"">(iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with the need for additional PAH-specific therapy;</p><p align=""justify"">(iv) Initiation of parenteral prostanoid therapy or long-term oxygen therapy for worsening of PAH;</p><p align=""justify"">(v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>The treatment must not be as monotherapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align=""justify"">For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred:</p><p align=""justify"">(i) Hospitalisation due to worsening PAH;</p><p align=""justify"">(ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with worsening of WHO functional class status;</p><p align=""justify"">(iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with the need for additional PAH-specific therapy;</p><p align=""justify"">(iv) Initiation of parenteral prostanoid therapy or long-term oxygen therapy for worsening of PAH;</p><p align=""justify"">(v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH.</p>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11207_9183_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","9183","11207","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An assessment of a patient&apos;s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An assessment of a patient&apos;s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p>Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 3 months treatment with methotrexate and 3 months treatment with sulfasalazine or leflunomide can be found on the Department of Human Services website (www.humanservices.gov.au)</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-02-01","Y","4708"
"11208_9105_R","Continuing treatment","AUTHORITY_REQUIRED","9105","11208","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-02-01","Y","4708"
"11210_4312_R","Initial treatment for up to 6 months","AUTHORITY_REQUIRED","4312","11210","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides); AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides); AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11211_4352_R","Initial treatment for up to 6 months","AUTHORITY_REQUIRED","4352","11211","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cows'' milk protein enteropathy with failure to thrive</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cows'' milk protein enteropathy with failure to thrive</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11212_4323_R","Initial treatment for up to 6 months","AUTHORITY_REQUIRED","4323","11212","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows'' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows'' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11213_4345_R","Continuing treatment","AUTHORITY_REQUIRED","4345","11213","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cows'' milk protein enteropathy with failure to thrive</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have had failure to thrive prior to commencement with initial treatment; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cows'' milk protein enteropathy with failure to thrive</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have had failure to thrive prior to commencement with initial treatment; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p/><p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11214_4338_R","Continuing treatment","AUTHORITY_REQUIRED","4338","11214","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined intolerance to cows'' milk protein, soy protein and protein hydrolysate formulae</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be older than 24 months of age.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined intolerance to cows'' milk protein, soy protein and protein hydrolysate formulae</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be older than 24 months of age.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p/><p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11215_4339_R","Continuing treatment","AUTHORITY_REQUIRED","4339","11215","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement with initial treatment; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement with initial treatment; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p/><p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11216_4330_R","null","AUTHORITY_REQUIRED","4330","11216","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk anaphylaxis</p><br/><p>Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction.</p><p/> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk anaphylaxis</p><br/><p>Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction.</p><p/> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p/><p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11217_4337_R","Continuing treatment","AUTHORITY_REQUIRED","4337","11217","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows'' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows'' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p/><p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11218_4305_R","Initial treatment for up to 6 months","AUTHORITY_REQUIRED","4305","11218","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined intolerance to cows'' milk protein, soy protein and protein hydrolysate formulae</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be older than 24 months of age.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined intolerance to cows'' milk protein, soy protein and protein hydrolysate formulae</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be older than 24 months of age.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11219_5945_R","Initial treatment for up to 3 months","AUTHORITY_REQUIRED","5945","11219","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Initial treatment for up to 3 months</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must require an amino acid based formula as a component of a dietary elimination program; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align=""justify"">Treatment with oral steroids should not be commenced during the period of initial treatment.</p><p/> <p align=""justify"">Eosinophilic oesophagitis is demonstrated by the following criteria:</p><p align=""justify"">(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and</p><p align=""justify"">(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and</p><p align=""justify"">(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.</p> <p/><p align=""justify"">The date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Initial treatment for up to 3 months</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must require an amino acid based formula as a component of a dietary elimination program; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align=""justify"">Treatment with oral steroids should not be commenced during the period of initial treatment.</p><p/> <p align=""justify"">Eosinophilic oesophagitis is demonstrated by the following criteria:</p><p align=""justify"">(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and</p><p align=""justify"">(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and</p><p align=""justify"">(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.</p> <p/><p align=""justify"">The date of birth of the patient must be included in the authority application.</p><p/> <p/><p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11220_9276_R","Initial treatment","AUTHORITY_REQUIRED","9276","11220","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic or myeloproliferative disorder</p><br/><p>Initial treatment</p><br/><p>Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by standard karyotyping; or</p> <p>Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by fluorescence in situ hybridization (FISH); or</p> <p>Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by PDGFRB fusion gene transcript; AND</p> <p>Patient must have previously failed an adequate trial of conventional therapy with cytarabine; or</p> <p>Patient must have previously failed an adequate trial of conventional therapy with etoposide; or</p> <p>Patient must have previously failed an adequate trial of conventional therapy with hydroxycarbamide (hydroxyurea); AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day.</p> <p align=""justify"">A bone marrow biopsy report demonstrating the presence of a myelodysplastic or myeloproliferative disorder, a pathology report confirming the platelet-derived growth factor receptor (PDGFR) gene re-arrangement and details of the prior trialled therapy and the response must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic or myeloproliferative disorder</p><br/><p>Initial treatment</p><br/><p>Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by standard karyotyping; or</p> <p>Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by fluorescence in situ hybridization (FISH); or</p> <p>Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by PDGFRB fusion gene transcript; AND</p> <p>Patient must have previously failed an adequate trial of conventional therapy with cytarabine; or</p> <p>Patient must have previously failed an adequate trial of conventional therapy with etoposide; or</p> <p>Patient must have previously failed an adequate trial of conventional therapy with hydroxycarbamide (hydroxyurea); AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day.</p> <p align=""justify"">A bone marrow biopsy report demonstrating the presence of a myelodysplastic or myeloproliferative disorder, a pathology report confirming the platelet-derived growth factor receptor (PDGFR) gene re-arrangement and details of the prior trialled therapy and the response must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11221_9240_R","Initial treatment","AUTHORITY_REQUIRED","9240","11221","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dermatofibrosarcoma protuberans</p><br/><p>Initial treatment</p><br/><p>The condition must be unresectable; or</p> <p>The condition must be locally recurrent; or</p> <p>The condition must be metastatic; AND</p> <p>The treatment must not exceed a maximum dose of 800 mg per day.</p> <p align=""justify"">Details of unresectable tumour or site of the local recurrence or site(s) of metastatic disease must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dermatofibrosarcoma protuberans</p><br/><p>Initial treatment</p><br/><p>The condition must be unresectable; or</p> <p>The condition must be locally recurrent; or</p> <p>The condition must be metastatic; AND</p> <p>The treatment must not exceed a maximum dose of 800 mg per day.</p> <p align=""justify"">Details of unresectable tumour or site of the local recurrence or site(s) of metastatic disease must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11242_11261_R","Initial treatment - dose titration","AUTHORITY_REQUIRED","11261","11242","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment - dose titration</p><br/><p>Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy; AND</p> <p>Patient must have WHO Functional Class III PAH at treatment initiation with this drug; or</p> <p>Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND</p> <p>The treatment must be for dose titration purposes with the intent of completing the titration within 12 weeks; AND</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>The treatment must not be as monotherapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align=""justify"">PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) is defined as follows:</p><p align=""justify"">(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or</p><p align=""justify"">(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment - dose titration</p><br/><p>Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy; AND</p> <p>Patient must have WHO Functional Class III PAH at treatment initiation with this drug; or</p> <p>Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND</p> <p>The treatment must be for dose titration purposes with the intent of completing the titration within 12 weeks; AND</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>The treatment must not be as monotherapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align=""justify"">PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) is defined as follows:</p><p align=""justify"">(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or</p><p align=""justify"">(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11248_9073_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","9073","11248","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-02-01","Y","4708"
"11250_4368_R","Initial treatment for up to 3 months","AUTHORITY_REQUIRED","4368","11250","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Initial treatment for up to 3 months</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must require an amino acid based formula as a component of a dietary elimination program; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align=""justify"">Treatment with oral steroids should not be commenced during the period of initial treatment.</p><p/> <p align=""justify"">Eosinophilic oesophagitis is demonstrated by the following criteria:</p><p align=""justify"">(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and</p><p align=""justify"">(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and</p><p align=""justify"">(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.</p> <p/><p align=""justify"">The date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Initial treatment for up to 3 months</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must require an amino acid based formula as a component of a dietary elimination program; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align=""justify"">Treatment with oral steroids should not be commenced during the period of initial treatment.</p><p/> <p align=""justify"">Eosinophilic oesophagitis is demonstrated by the following criteria:</p><p align=""justify"">(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and</p><p align=""justify"">(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and</p><p align=""justify"">(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.</p> <p/><p align=""justify"">The date of birth of the patient must be included in the authority application.</p><p/> <p/><p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 52, may be authorised.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11268_9155_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","9155","11268","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An assessment of a patient&apos;s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An assessment of a patient&apos;s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p>Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 3 months treatment with methotrexate and 3 months treatment with sulfasalazine or leflunomide can be found on the Department of Human Services website (www.humanservices.gov.au)</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-02-01","Y","4708"
"11272_4599_R","null","AUTHORITY_REQUIRED","4599","11272","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Homocystinuria</p><br/><p>The treatment must be as adjunctive therapy to current standard care; AND</p> <p>The condition must be treated by or in consultation with a metabolic physician.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Homocystinuria</p><br/><p>The treatment must be as adjunctive therapy to current standard care; AND</p> <p>The condition must be treated by or in consultation with a metabolic physician.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11293_6395_R","null","AUTHORITY_REQUIRED","6395","11293","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Onychomycosis</p><br/><p>The condition must be proximal or extensive (greater than 80% nail involvement); AND</p> <p>Patient must have failed to respond to topical treatment; AND</p> <p>The condition must be due to dermatophyte infection proven by microscopy and confirmed by an Approved Pathology Provider; or</p> <p>The condition must be due to dermatophyte infection proven by culture and confirmed by an Approved Pathology Provider.</p> <p>The date of the pathology report must be provided at the time of application and must not be more than 12 months old</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Onychomycosis</p><br/><p>The condition must be proximal or extensive (greater than 80% nail involvement); AND</p> <p>Patient must have failed to respond to topical treatment; AND</p> <p>The condition must be due to dermatophyte infection proven by microscopy and confirmed by an Approved Pathology Provider; or</p> <p>The condition must be due to dermatophyte infection proven by culture and confirmed by an Approved Pathology Provider.</p> <p>The date of the pathology report must be provided at the time of application and must not be more than 12 months old</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2021-02-01","N","4708"
"11310_11310_R","One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control","AUTHORITY_REQUIRED","11310","11310","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex gastro-oesophageal reflux disease (GORD)</p><br/><p>One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a surgeon with expertise in the upper gastrointestinal tract; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialists in relation to this current PBS benefit being sought, with the specialist''s name documented in the patient''s medical records for auditing purposes; or</p> <p>Must be treated by a medical practitioner who has not consulted a specialist, but only if treatment continues therapy initiated under this restriction with involvement by a specialist (i.e. continuing treatment initiated for non-complex GORD does not meet this criterion), with the specialist''s name documented in the patient''s medical records for auditing purposes; AND</p> <p>The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND</p> <p>Patient must must have symptoms inadequately controlled with each of: (i) a standard dose proton pump inhibitor (PPI) administered once daily, (ii) a low dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; or</p> <p>Patient must be assessed for the risks/benefits of a step-down in dosing from standard dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; or</p> <p>Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; or</p> <p>Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.</p> <p align=""justify"">Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex gastro-oesophageal reflux disease (GORD)</p><br/><p>One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a surgeon with expertise in the upper gastrointestinal tract; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialists in relation to this current PBS benefit being sought, with the specialist''s name documented in the patient''s medical records for auditing purposes; or</p> <p>Must be treated by a medical practitioner who has not consulted a specialist, but only if treatment continues therapy initiated under this restriction with involvement by a specialist (i.e. continuing treatment initiated for non-complex GORD does not meet this criterion), with the specialist''s name documented in the patient''s medical records for auditing purposes; AND</p> <p>The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND</p> <p>Patient must must have symptoms inadequately controlled with each of: (i) a standard dose proton pump inhibitor (PPI) administered once daily, (ii) a low dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; or</p> <p>Patient must be assessed for the risks/benefits of a step-down in dosing from standard dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; or</p> <p>Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; or</p> <p>Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.</p> <p align=""justify"">Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2021-03-01","N","4708"
"11360_11360_R","null","STREAMLINED","11360","11360","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">This product is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2021-03-01","N","4708"
"11370_11370_R","One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control","AUTHORITY_REQUIRED","11370","11370","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex gastro-oesophageal reflux disease (GORD)</p><br/><p>One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a surgeon with expertise in the upper gastrointestinal tract; AND</p> <p>The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND</p> <p>Patient must have symptoms inadequately controlled with each of: (i) a high dose proton pump inhibitor (PPI) administered once daily, (ii) a standard dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; or</p> <p>Patient must be assessed for the risks/benefits of a step-down in dosing from a high dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; or</p> <p>Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; or</p> <p>Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.</p> <p align=""justify"">Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex gastro-oesophageal reflux disease (GORD)</p><br/><p>One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a surgeon with expertise in the upper gastrointestinal tract; AND</p> <p>The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND</p> <p>Patient must have symptoms inadequately controlled with each of: (i) a high dose proton pump inhibitor (PPI) administered once daily, (ii) a standard dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; or</p> <p>Patient must be assessed for the risks/benefits of a step-down in dosing from a high dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; or</p> <p>Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; or</p> <p>Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.</p> <p align=""justify"">Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2021-03-01","N","4708"
"11374_11374_R","Continuing or resuming treatment of the whole body","AUTHORITY_REQUIRED","11374","11374","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Continuing or resuming treatment of the whole body</p><br/><p>Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the whole body; AND</p> <p>Patient must have achieved an adequate response within the first 16 weeks of treatment; or</p> <p>Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; or</p> <p>Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND</p> <p>The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist.</p> <p align=""justify"">For the purposes of this restriction, an adequate response to treatment is defined as:</p><p align=""justify"">(a) An improvement/maintenance in the Eczema Area and Severity Index (EASI) score of at least 50% compared to baseline; and</p><p align=""justify"">(b) An improvement/maintenance in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline</p><p align=""justify"">Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the &apos;Grandfather listing&apos; authority application will suffice as an adequate response for requirement (b) above.</p><p align=""justify"">State each of the current EASI and DLQI scores for this authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Continuing or resuming treatment of the whole body</p><br/><p>Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the whole body; AND</p> <p>Patient must have achieved an adequate response within the first 16 weeks of treatment; or</p> <p>Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; or</p> <p>Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND</p> <p>The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist.</p> <p align=""justify"">For the purposes of this restriction, an adequate response to treatment is defined as:</p><p align=""justify"">(a) An improvement/maintenance in the Eczema Area and Severity Index (EASI) score of at least 50% compared to baseline; and</p><p align=""justify"">(b) An improvement/maintenance in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline</p><p align=""justify"">Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the &apos;Grandfather listing&apos; authority application will suffice as an adequate response for requirement (b) above.</p><p align=""justify"">State each of the current EASI and DLQI scores for this authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2021-03-01","N","4708"
"11377_11377_R","Continuing or resuming treatment of the face and/or hands","AUTHORITY_REQUIRED","11377","11377","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Continuing or resuming treatment of the face and/or hands</p><br/><p>Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the face/hands; AND</p> <p>Patient must have achieved an adequate response within the first 16 weeks of treatment; or</p> <p>Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; or</p> <p>Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND</p> <p>The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist.</p> <p align=""justify"">For the purposes of this restriction, an adequate response to treatment of the face/hands is defined as:</p><p align=""justify"">(a) (i) A rating of either mild (1) to none (0) on at least 3 of the assessments of erythema, oedema/papulation, excoriation and lichenification mentioned in the Eczema Area and Severity Index (EASI); or</p><p align=""justify"">(ii) At least a 75% reduction in the skin area affected by this condition compared to baseline; and</p><p align=""justify"">(b) An improvement in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline</p><p align=""justify"">Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the &apos;Grandfather listing&apos; authority application will suffice as an adequate response for requirement (b) above.</p><p align=""justify"">Document each qualifying response measure in the patient&apos;s medical records for PBS compliance auditing purposes</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Continuing or resuming treatment of the face and/or hands</p><br/><p>Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the face/hands; AND</p> <p>Patient must have achieved an adequate response within the first 16 weeks of treatment; or</p> <p>Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; or</p> <p>Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND</p> <p>The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist.</p> <p align=""justify"">For the purposes of this restriction, an adequate response to treatment of the face/hands is defined as:</p><p align=""justify"">(a) (i) A rating of either mild (1) to none (0) on at least 3 of the assessments of erythema, oedema/papulation, excoriation and lichenification mentioned in the Eczema Area and Severity Index (EASI); or</p><p align=""justify"">(ii) At least a 75% reduction in the skin area affected by this condition compared to baseline; and</p><p align=""justify"">(b) An improvement in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline</p><p align=""justify"">Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the &apos;Grandfather listing&apos; authority application will suffice as an adequate response for requirement (b) above.</p><p align=""justify"">Document each qualifying response measure in the patient&apos;s medical records for PBS compliance auditing purposes</p>","N","N","N","IMMEDIATE","ALL","N","2021-03-01","N","4708"
"11429_N","null","null","null","null","null","<p/><p align=""justify"">A LAMA includes tiotropium, glycopyrronium, aclidinium or umeclidinium.</p><p/>","Y","N","N","null","null","N","2014-11-01","N","4708"
"11446_11445_R","null","STREAMLINED","11445","11446","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2021-04-01","N","4708"
"11461_11385_R","null","STREAMLINED","11385","11461","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2021-04-01","N","4708"
"11468_N","null","null","null","null","null","<p align=""justify"">Not indicated for the treatment of intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect requiring a ketogenic diet. </p>","Y","N","N","null","null","N","2014-11-01","N","4708"
"11482_11482_R","null","RESTRICTED","11482","11482","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pyridoxine dependent epilepsy</p><br/><p>Patient must be managed on a low lysine diet for pyridoxine dependent epilepsy; AND</p> <p>The condition must be treated by or in consultation with a metabolic physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pyridoxine dependent epilepsy</p><br/><p>Patient must be managed on a low lysine diet for pyridoxine dependent epilepsy; AND</p> <p>The condition must be treated by or in consultation with a metabolic physician.</p>","N","N","N","IMMEDIATE","ALL","N","2021-04-01","N","4708"
"11494_10431_R","Continuing treatment","AUTHORITY_REQUIRED","10431","11494","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-04-01","N","4708"
"11519_N","null","null","null","null","null","<p align=""justify"">For patients with graft versus host disease, acute myeloid leukaemia or myelodysplastic syndrome, applications for an increased maximum quantity to allow for up to 1 month&apos;s treatment and repeats sufficient for up to 6 months&apos; treatment may be authorised. </p>","Y","N","N","null","null","N","2014-12-01","N","4708"
"11520_N","null","null","null","null","null","<p align=""justify"">For patients undergoing allogeneic haematopoietic stem cell transplant, applications for an increased maximum quantity to allow for up to 1 month&apos;s treatment and repeats sufficient for up to 2 months&apos; treatment may be authorised.</p>","Y","N","N","null","null","N","2014-12-01","N","4708"
"11522_11604_R","Subsequent continuing treatment","STREAMLINED","11604","11522","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p>","N","N","N","IMMEDIATE","ALL","N","2021-04-01","N","4708"
"11528_11529_R","Subsequent continuing treatment","STREAMLINED","11529","11528","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated a response to treatment with this drug for this condition; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated a response to treatment with this drug for this condition; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2021-04-01","N","4708"
"11532_N","null","null","null","null","null","<p/><p align=""justify"">A patient may only qualify for PBS-subsidised treatment under this restriction once in a lifetime.</p><p/>","Y","N","N","null","null","N","2014-12-01","N","4708"
"11535_11635_R","Subsequent continuing treatment, Whole body","STREAMLINED","11635","11535","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2021-04-01","N","4708"
"11580_11523_R","Subsequent continuing treatment","STREAMLINED","11523","11580","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2021-04-01","N","4708"
"11595_N","null","null","null","null","null","<p/><p align=""justify"">Application for an increased maximum quantity to allow for up to 1 month&apos;s treatment and repeats sufficient for up to 6 months&apos; treatment may be authorised.</p><p/>","Y","N","N","null","null","N","2014-12-01","N","4708"
"11630_11606_R","Subsequent continuing treatment, Face, hand, foot","STREAMLINED","11606","11630","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2021-04-01","N","4708"
"11637_11524_R","Subsequent continuing treatment","STREAMLINED","11524","11637","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2021-04-01","N","4708"
"11658_11644_R","null","RESTRICTED","11644","11658","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency; AND</p> <p>Patient must be undergoing treatment under the strict supervision of a dietitian, together with at least one of: (i) a metabolic physician, (ii) a neurologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency; AND</p> <p>Patient must be undergoing treatment under the strict supervision of a dietitian, together with at least one of: (i) a metabolic physician, (ii) a neurologist.</p>","N","N","N","IMMEDIATE","ALL","N","2021-06-01","N","4708"
"11673_11673_R","null","STREAMLINED","11673","11673","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of preterm birth</p><br/><p>Patient must have a singleton pregnancy; AND</p> <p>Patient must have at least one of: (i) short cervix (mid-trimester sonographic cervix no greater than 25 mm), (ii) a history of spontaneous preterm birth; AND</p> <p>The treatment must be administered no earlier than at 16 weeks gestation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of preterm birth</p><br/><p>Patient must have a singleton pregnancy; AND</p> <p>Patient must have at least one of: (i) short cervix (mid-trimester sonographic cervix no greater than 25 mm), (ii) a history of spontaneous preterm birth; AND</p> <p>The treatment must be administered no earlier than at 16 weeks gestation.</p>","N","N","N","IMMEDIATE","ALL","N","2021-06-01","N","4708"
"11683_11683_R","null","RESTRICTED","11683","11683","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For use in patients receiving palliative care</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For use in patients receiving palliative care</p>","N","N","N","IMMEDIATE","ALL","N","2021-06-01","N","4708"
"11696_11696_R","null","AUTHORITY_REQUIRED","11696","11696","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disabling pain</p><br/><p>Patient must not be opioid naive; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND</p> <p>Patient must be undergoing palliative care.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authority requests for treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disabling pain</p><br/><p>Patient must not be opioid naive; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND</p> <p>Patient must be undergoing palliative care.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authority requests for treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2021-06-01","N","4708"
"11697_11697_R","null","STREAMLINED","11697","11697","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND</p> <p>Patient must be undergoing palliative care.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND</p> <p>Patient must be undergoing palliative care.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2021-06-01","N","4708"
"11698_6986_R","Continuing","STREAMLINED","6986","11698","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>","N","N","N","IMMEDIATE","ALL","N","2021-06-01","N","4708"
"11745_11746_R","null","RESTRICTED","11746","11745","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For use in patients receiving palliative care</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For use in patients receiving palliative care</p>","N","N","N","IMMEDIATE","ALL","N","2021-06-01","N","4708"
"11753_11753_R","null","AUTHORITY_REQUIRED","11753","11753","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disabling pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance; AND</p> <p>Patient must be undergoing palliative care.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authority requests for treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disabling pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance; AND</p> <p>Patient must be undergoing palliative care.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authority requests for treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2021-06-01","N","4708"
"11754_6985_R","Initial","STREAMLINED","6985","11754","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>","N","N","N","IMMEDIATE","ALL","N","2021-06-01","N","4708"
"11756_11815_R","Induction treatment","AUTHORITY_REQUIRED","11815","11756","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage II bulky or Stage III/IV follicular lymphoma</p><br/><p>Induction treatment</p><br/><p>The condition must be CD20 positive; AND</p> <p>The condition must be previously untreated; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for induction treatment purposes only; AND</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The treatment must not exceed 10 doses for induction treatment with this drug for this condition.</p> <p align=""justify"">A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under:</p><p align=""justify"">i) the previously untreated induction treatment restriction; or</p><p align=""justify"">ii) the rituximab-refractory re-induction restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage II bulky or Stage III/IV follicular lymphoma</p><br/><p>Induction treatment</p><br/><p>The condition must be CD20 positive; AND</p> <p>The condition must be previously untreated; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for induction treatment purposes only; AND</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The treatment must not exceed 10 doses for induction treatment with this drug for this condition.</p> <p align=""justify"">A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under:</p><p align=""justify"">i) the previously untreated induction treatment restriction; or</p><p align=""justify"">ii) the rituximab-refractory re-induction restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2021-06-01","N","4708"
"11757_11785_R","Maintenance therapy","AUTHORITY_REQUIRED","11785","11757","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Follicular lymphoma</p><br/><p>Maintenance therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug under the rituximab refractory initial restriction; AND</p> <p>The condition must be CD20 positive; AND</p> <p>The condition must have been refractory to treatment with rituximab; AND</p> <p>Patient must have demonstrated a partial or complete response to PBS-subsidised re-induction treatment with this drug for this condition; AND</p> <p>The treatment must be maintenance therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Follicular lymphoma</p><br/><p>Maintenance therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug under the rituximab refractory initial restriction; AND</p> <p>The condition must be CD20 positive; AND</p> <p>The condition must have been refractory to treatment with rituximab; AND</p> <p>Patient must have demonstrated a partial or complete response to PBS-subsidised re-induction treatment with this drug for this condition; AND</p> <p>The treatment must be maintenance therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2021-06-01","N","4708"
"11786_11787_R","Maintenance therapy","AUTHORITY_REQUIRED","11787","11786","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage II bulky or Stage III/IV follicular lymphoma</p><br/><p>Maintenance therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug under the previously untreated initial restriction; AND</p> <p>The condition must be CD20 positive; AND</p> <p>Patient must have demonstrated a partial or complete response to PBS subsidised induction treatment with this drug for this condition; AND</p> <p>The treatment must be maintenance therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage II bulky or Stage III/IV follicular lymphoma</p><br/><p>Maintenance therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug under the previously untreated initial restriction; AND</p> <p>The condition must be CD20 positive; AND</p> <p>Patient must have demonstrated a partial or complete response to PBS subsidised induction treatment with this drug for this condition; AND</p> <p>The treatment must be maintenance therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2021-06-01","N","4708"
"11800_11699_R","Maintenance therapy - Continuing treatment","AUTHORITY_REQUIRED","11699","11800","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Maintenance therapy - Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial maintenance treatment restriction; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not be undergoing or have undergone a stem cell transplant.</p> <p align=""justify"">A maximum of 9 cycles will be authorised under this restriction in a lifetime.</p> <p align=""justify"">Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.</p><p align=""justify"">If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.</p><p align=""justify"">Progressive disease is defined as the presence of any of the following:</p><ul><li>Leukaemic cells in the CSF;</li><li>Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;</li><li>Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;</li><li>Extramedullary leukaemia.</li></ul> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Maintenance therapy - Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial maintenance treatment restriction; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not be undergoing or have undergone a stem cell transplant.</p> <p align=""justify"">A maximum of 9 cycles will be authorised under this restriction in a lifetime.</p> <p align=""justify"">Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.</p><p align=""justify"">If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.</p><p align=""justify"">Progressive disease is defined as the presence of any of the following:</p><ul><li>Leukaemic cells in the CSF;</li><li>Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;</li><li>Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;</li><li>Extramedullary leukaemia.</li></ul> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>","N","N","N","IMMEDIATE","ALL","N","2021-06-01","N","4708"
"11809_11755_R","Re-induction treatment","AUTHORITY_REQUIRED","11755","11809","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Follicular lymphoma</p><br/><p>Re-induction treatment</p><br/><p>Patient must not have previously received PBS-subsidised obinutuzumab; AND</p> <p>The condition must be CD20 positive; AND</p> <p>The condition must be refractory to treatment with rituximab for this condition; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for re-induction treatment purposes only; AND</p> <p>The treatment must be in combination with bendamustine; AND</p> <p>The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition.</p> <p align=""justify"">The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.</p> <p align=""justify"">A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under:</p><p align=""justify"">i) the previously untreated induction treatment restriction; or</p><p align=""justify"">ii) the rituximab-refractory re-induction restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Follicular lymphoma</p><br/><p>Re-induction treatment</p><br/><p>Patient must not have previously received PBS-subsidised obinutuzumab; AND</p> <p>The condition must be CD20 positive; AND</p> <p>The condition must be refractory to treatment with rituximab for this condition; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for re-induction treatment purposes only; AND</p> <p>The treatment must be in combination with bendamustine; AND</p> <p>The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition.</p> <p align=""justify"">The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.</p> <p align=""justify"">A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under:</p><p align=""justify"">i) the previously untreated induction treatment restriction; or</p><p align=""justify"">ii) the rituximab-refractory re-induction restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2021-06-01","N","4708"
"11819_11784_R","null","STREAMLINED","11784","11819","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic migraine</p><br/><p>Must be treated by a neurologist; AND</p> <p>Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with botulinum toxin type A neurotoxin; AND</p> <p>Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with botulinum toxin type A neurotoxin; AND</p> <p>Patient must have achieved and maintained a 50% or greater reduction from baseline in the number of headache days per month after two treatment cycles (each of 12 weeks duration) in order to be eligible for continuing PBS-subsidised treatment; AND</p> <p>Patient must be appropriately managed by his or her practitioner for medication overuse headache, prior to initiation of treatment with botulinum toxin; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Contraindications to treatment include known sensitivity to botulinum toxin.</p> <p>Chronic migraine</p><br/><p>Must be treated by a neurologist; AND</p> <p>Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with botulinum toxin type A neurotoxin; AND</p> <p>Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with botulinum toxin type A neurotoxin; AND</p> <p>Patient must have achieved and maintained a 50% or greater reduction from baseline in the number of headache days per month after two treatment cycles (each of 12 weeks duration) in order to be eligible for continuing PBS-subsidised treatment; AND</p> <p>Patient must be appropriately managed by his or her practitioner for medication overuse headache, prior to initiation of treatment with botulinum toxin; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.</p> <p>The units used to express the potency of botulinum toxin preparations currently available for PBS subsidy are not equivalent.</p>","N","N","N","IMMEDIATE","ALL","N","2021-06-01","N","4708"
"11829_11939_R","Continuing treatment beyond 3 months","STREAMLINED","11939","11829","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>Patient must require dose adjustment; AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>Patient must require dose adjustment; AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11830_11915_R","Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","11915","11830","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition if relevant; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition if relevant; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11831_11890_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","11890","11831","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy.</p> <p align=""justify"">Where an assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond, or to have failed to sustain a response to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy.</p> <p align=""justify"">Where an assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond, or to have failed to sustain a response to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11832_11981_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","11981","11832","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11833_11834_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","11834","11833","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count, ESR and/or CRP must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count, ESR and/or CRP must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11835_11835_R","null","STREAMLINED","11835","11835","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of preterm birth</p><br/><p>Patient must have a singleton pregnancy; AND</p> <p>Patient must have at least one of: (i) short cervix (mid-trimester sonographic cervix no greater than 25 mm), (ii) a history of spontaneous preterm birth; AND</p> <p>The treatment must be administered no earlier than at 16 weeks gestation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of preterm birth</p><br/><p>Patient must have a singleton pregnancy; AND</p> <p>Patient must have at least one of: (i) short cervix (mid-trimester sonographic cervix no greater than 25 mm), (ii) a history of spontaneous preterm birth; AND</p> <p>The treatment must be administered no earlier than at 16 weeks gestation.</p>","N","N","N","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11837_11960_R","Existing pregnancy to birth","AUTHORITY_REQUIRED","11960","11837","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>Existing pregnancy to birth</p><br/><p>Patient must be pregnant; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug at least once in a lifetime, with an adequate response defined as a reduction in phenylalanine levels from baseline during initial responsiveness testing of no less than 30%; AND</p> <p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must not be undergoing further treatment with this drug as a PBS benefit, post-partum in the absence of actively trying to conceive a subsequent child/a known subsequent pregnancy; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug under another non-maternal PBS-listing (apply under either listing type, but not both simultaneously).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>Existing pregnancy to birth</p><br/><p>Patient must be pregnant; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug at least once in a lifetime, with an adequate response defined as a reduction in phenylalanine levels from baseline during initial responsiveness testing of no less than 30%; AND</p> <p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must not be undergoing further treatment with this drug as a PBS benefit, post-partum in the absence of actively trying to conceive a subsequent child/a known subsequent pregnancy; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug under another non-maternal PBS-listing (apply under either listing type, but not both simultaneously).</p> <p align=""justify"">Request an appropriate maximum quantity (with the number of packs being a whole number) to provide approximately 30 days treatment duration per dispensing, based on dosing no greater than 20 mg/kg per day.</p> <p align=""justify"">Request an appropriate number of repeats (whole number) relative to the expected birth date such that treatment is not continued post-partum by a whole prescription quantity. If the expected birth date is within the next 30 days at the time of the authority application, do not request repeats.</p> <p align=""justify"">This PBS listing intends to subsidise treatment only whilst the patient is pregnant. Treatment is to be discontinued upon birth under this listing. Whilst a patient may benefit from continued treatment post-partum, continued treatment with this drug post-partum is not PBS subsidised in the absence of actively trying to conceive again/a known subsequent pregnancy.</p>","N","N","N","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11859_9064_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","9064","11859","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11862_11867_R","First continuing treatment","AUTHORITY_REQUIRED","11867","11862","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11863_11865_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","11865","11863","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug within this treatment cycle, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug within this treatment cycle, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11876_11974_R","Initial treatment","STREAMLINED","11974","11876","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align=""justify"">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align=""justify"">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p> <p align=""justify"">Patients who have developed intolerance to sunitinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised pazopanib.</p> <p>Patients who have progressive disease with pazopanib are no longer eligible for PBS-subsidised pazopanib.</p>","N","N","N","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11877_11937_R","Continuing treatment beyond 3 months","STREAMLINED","11937","11877","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11881_11975_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","11975","11881","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11885_11886_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","11886","11885","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11887_11919_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","11919","11887","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11888_11979_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","11979","11888","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11889_9172_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","9172","11889","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11914_11878_R","Initial treatment","STREAMLINED","11878","11914","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align=""justify"">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align=""justify"">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p> <p align=""justify"">Patients who have developed intolerance to pazopanib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised sunitinib.</p> <p align=""justify"">Patients who have progressive disease with sunitinib are no longer eligible for PBS-subsidised sunitinib.</p>","N","N","N","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11920_9172_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","9172","11920","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11921_11959_R","Continuing treatment","AUTHORITY_REQUIRED","11959","11921","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11929_11906_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","11906","11929","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11942_11883_R","Continuing treatment","AUTHORITY_REQUIRED","11883","11942","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a dose increase from tofacitinib 5mg twice daily to tofacitinib 10mg twice daily is required, tofacitinib 10mg may be authorised under the Balance of supply restriction to complete up to 24 weeks continuing treatment.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11943_9064_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","9064","11943","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11946_11918_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","11918","11946","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11954_11940_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","11940","11954","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11955_11956_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","11956","11955","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11957_11917_R","Continuing treatment","AUTHORITY_REQUIRED","11917","11957","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy.</p> <p align=""justify"">Where an assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond, or to have failed to sustain a response to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy.</p> <p align=""justify"">Where an assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond, or to have failed to sustain a response to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11969_11944_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","11944","11969","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11976_11976_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","11976","11976","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11977_11978_R","Continuing treatment","AUTHORITY_REQUIRED","11978","11977","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11980_11958_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","11958","11980","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-07-01","Y","4708"
"11982_11836_R","Pre-conception through to when pregnancy first becomes known","AUTHORITY_REQUIRED","11836","11982","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>Pre-conception through to when pregnancy first becomes known</p><br/><p>Patient must have demonstrated an adequate response to treatment with this drug at least once in a lifetime, with an adequate response defined as a reduction in phenylalanine levels from baseline during initial responsiveness testing of no less than 30%; AND</p> <p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must not be undergoing treatment with this drug under this Treatment phase, following completion of this authority application, for more than 13 cumulative months (assuming 1 month consists of 30 days); AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug under another non-maternal PBS-listing (apply under either listing type, but not both simultaneously); AND</p> <p>Patient must be actively trying to conceive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>Pre-conception through to when pregnancy first becomes known</p><br/><p>Patient must have demonstrated an adequate response to treatment with this drug at least once in a lifetime, with an adequate response defined as a reduction in phenylalanine levels from baseline during initial responsiveness testing of no less than 30%; AND</p> <p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must not be undergoing treatment with this drug under this Treatment phase, following completion of this authority application, for more than 13 cumulative months (assuming 1 month consists of 30 days); AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug under another non-maternal PBS-listing (apply under either listing type, but not both simultaneously); AND</p> <p>Patient must be actively trying to conceive.</p> <p align=""justify"">Request an appropriate maximum quantity (with the number of packs being a whole number) to provide approximately 30 days treatment duration per dispensing, based on dosing no greater than 20 mg/kg per day.</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p align=""justify"">This PBS listing intends to subsidise up to 13 cumulative months (assuming 1 month consists of 30 days) of treatment during the pre-conception phase per known pregnancy. The time taken to conceive can vary for each patient, but where this treatment phase of &apos;pre-conception through to when pregnancy becomes first known&apos; exceeds a cumulative 13 months, continued treatment beyond this time up to the point of conception, is not PBS subsidised.</p><p align=""justify"">13 cumulative months comprises of the time taken to achieve desired phenylalanine level control and the time taken for pregnancy to become known (e.g. If it takes 3 months to reach desired phenylalanine level control, 10 months of PBS-subsidised treatment remain in which to achieve pregnancy; if it takes only 1 month to reach desired phenylalanine level control, 12 months of PBS-subsidised treatment remain in which to achieve pregnancy)</p>","N","N","N","IMMEDIATE","ALL","N","2021-07-01","N","4708"
"11994_12045_R","Initial treatment","STREAMLINED","12045","11994","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have RAS wild-type metastatic colorectal cancer; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The condition must have failed to respond to first-line chemotherapy; or</p> <p>The condition must have progressed following first-line treatment with pembrolizumab for dMMR mCRC; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p/><p align=""justify"">Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.</p><p/> <p/><p align=""justify"">Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have RAS wild-type metastatic colorectal cancer; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The condition must have failed to respond to first-line chemotherapy; or</p> <p>The condition must have progressed following first-line treatment with pembrolizumab for dMMR mCRC; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p/><p align=""justify"">Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.</p><p/> <p/><p align=""justify"">Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.</p><p/> <p align=""justify"">Special Pricing Arrangements apply.</p> <p align=""justify"">This drug is not PBS-subsidised for use in combination with another anti-EGFR antibody or in combination with an anti-VEGF antibody.</p>","N","N","N","IMMEDIATE","ALL","N","2021-08-01","N","4708"
"12015_12016_R","Continuing treatment","STREAMLINED","12016","12015","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; or</p> <p>Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of treatment with first-line pembrolizumab for dMMR mCRC; AND</p> <p>Patient must not have progressive disease; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p/><p align=""justify"">Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.</p><p/> <p/><p align=""justify"">Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; or</p> <p>Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of treatment with first-line pembrolizumab for dMMR mCRC; AND</p> <p>Patient must not have progressive disease; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p/><p align=""justify"">Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab.</p><p/> <p/><p align=""justify"">Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab.</p><p/> <p align=""justify"">This drug is not PBS-subsidised for use in combination with another anti-EGFR antibody or in combination with an anti-VEGF antibody.</p> <p align=""justify"">This drug is not PBS-subsidised when chemotherapy partners are switched whilst maintaining an anti-EGFR antibody backbone in the face of progressive disease.</p> <p align=""justify"">The treatment must not exceed a single course of therapy with this drug for metastatic colorectal cancer in a patient&apos;s lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2021-08-01","N","4708"
"12029_12029_R","Continuing treatment","STREAMLINED","12029","12029","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic migraine</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist neurologist or in consultation with a specialist neurologist; AND</p> <p>Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved and maintained a 50% or greater reduction from baseline in the number of migraine days per month; AND</p> <p>Patient must continue to be appropriately managed for medication overuse headache.</p> <p align=""justify"">Patient must have the number of migraine days per month documented in their medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic migraine</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist neurologist or in consultation with a specialist neurologist; AND</p> <p>Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved and maintained a 50% or greater reduction from baseline in the number of migraine days per month; AND</p> <p>Patient must continue to be appropriately managed for medication overuse headache.</p> <p align=""justify"">Patient must have the number of migraine days per month documented in their medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2021-08-01","N","4708"
"12034_12035_R","Continuing treatment","STREAMLINED","12035","12034","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; or</p> <p>Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of treatment with first-line pembrolizumab for dMMR mCRC; AND</p> <p>Patient must not have progressive disease; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p/><p align=""justify"">Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.</p><p/> <p/><p align=""justify"">Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; or</p> <p>Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of treatment with first-line pembrolizumab for dMMR mCRC; AND</p> <p>Patient must not have progressive disease; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p/><p align=""justify"">Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.</p><p/> <p/><p align=""justify"">Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.</p><p/> <p align=""justify"">This drug is not PBS-subsidised for use in combination with another anti-EGFR antibody or in combination with an anti-VEGF antibody.</p> <p align=""justify"">This drug is not PBS-subsidised when chemotherapy partners are switched whilst maintaining an anti-EGFR antibody backbone in the face of progressive disease.</p> <p align=""justify"">The treatment must not exceed a single course of therapy with this drug for metastatic colorectal cancer in a patient&apos;s lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2021-08-01","N","4708"
"12046_11999_R","Initial treatment - balance of supply","AUTHORITY_REQUIRED","11999","12046","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Type III Short bowel syndrome with intestinal failure</p><br/><p>Initial treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit; AND</p> <p>Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND</p> <p>Patient must have received insufficient therapy with this drug under the initial treatment restriction to complete the maximum duration of 12 months of initial treatment; AND</p> <p>The treatment must provide no more than the balance of up to 12 months of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Type III Short bowel syndrome with intestinal failure</p><br/><p>Initial treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit; AND</p> <p>Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND</p> <p>Patient must have received insufficient therapy with this drug under the initial treatment restriction to complete the maximum duration of 12 months of initial treatment; AND</p> <p>The treatment must provide no more than the balance of up to 12 months of treatment.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-08-01","N","4708"
"12050_12059_R","Continuing treatment","AUTHORITY_REQUIRED","12059","12050","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response<i>. </i></p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response<i>. </i></p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2021-08-01","N","4708"
"12060_12074_R","Continuing treatment","STREAMLINED","12074","12060","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response<i>. </i></p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response<i>. </i></p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2021-08-01","N","4708"
"12070_12066_R","Initial treatment","STREAMLINED","12066","12070","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have RAS wild-type metastatic colorectal cancer; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The condition must have failed to respond to first-line chemotherapy; or</p> <p>The condition must have progressed following first-line treatment with pembrolizumab for dMMR mCRC; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p/><p align=""justify"">Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.</p><p/> <p/><p align=""justify"">Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have RAS wild-type metastatic colorectal cancer; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The condition must have failed to respond to first-line chemotherapy; or</p> <p>The condition must have progressed following first-line treatment with pembrolizumab for dMMR mCRC; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p/><p align=""justify"">Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.</p><p/> <p/><p align=""justify"">Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.</p><p/> <p align=""justify"">This drug is not PBS-subsidised for use in combination with another anti-EGFR antibody or in combination with an anti-VEGF antibody.</p>","N","N","N","IMMEDIATE","ALL","N","2021-08-01","N","4708"
"12073_12042_R","Continuing treatment","STREAMLINED","12042","12073","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response<i>. </i></p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are only eligible to receive continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response<i>. </i></p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2021-08-01","N","4708"
"12093_5945_R","Initial treatment for up to 3 months","AUTHORITY_REQUIRED","5945","12093","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Initial treatment for up to 3 months</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must require an amino acid based formula as a component of a dietary elimination program; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align=""justify"">Treatment with oral steroids should not be commenced during the period of initial treatment.</p><p/> <p align=""justify"">Eosinophilic oesophagitis is demonstrated by the following criteria:</p><p align=""justify"">(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and</p><p align=""justify"">(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and</p><p align=""justify"">(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.</p> <p/><p align=""justify"">The date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Initial treatment for up to 3 months</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must require an amino acid based formula as a component of a dietary elimination program; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align=""justify"">Treatment with oral steroids should not be commenced during the period of initial treatment.</p><p/> <p align=""justify"">Eosinophilic oesophagitis is demonstrated by the following criteria:</p><p align=""justify"">(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and</p><p align=""justify"">(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and</p><p align=""justify"">(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.</p> <p/><p align=""justify"">The date of birth of the patient must be included in the authority application.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12100_12240_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","12240","12100","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12144_5974_R","Continuing treatment","AUTHORITY_REQUIRED","5974","12144","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must have responded to an initial course of PBS-subsidised treatment; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align=""justify"">Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must have responded to an initial course of PBS-subsidised treatment; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align=""justify"">Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12149_12148_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","12148","12149","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes a completed Fistula Assessment form including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent fistula assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes a completed Fistula Assessment form including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent fistula assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-09-01","Y","4708"
"12151_12152_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","12152","12151","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) two completed authority prescription forms; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological medicine treatment including details of date and duration of treatment.</p> <p align=""justify"">The most recent fistula assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) two completed authority prescription forms; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological medicine treatment including details of date and duration of treatment.</p> <p align=""justify"">The most recent fistula assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this biological medicine.</p><p align=""justify""><b>Prescribing the 40 mg presentation:</b></p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats.</p><p align=""justify""><b>Prescribing the 80 mg presentation:</b></p><p align=""justify"">One prescription should be for the 80 mg presentation with a quantity of 3 units and zero repeats. This will enable doses at week 0 and week 2 to be completed. The second prescription should be written for 2 doses of 40 mg and 2 repeats.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-09-01","Y","4708"
"12187_12228_R","First continuing treatment","AUTHORITY_REQUIRED","12228","12187","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes a completed Fistula Assessment form including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent fistula assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes a completed Fistula Assessment form including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent fistula assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-09-01","Y","4708"
"12206_4305_R","Initial treatment for up to 6 months","AUTHORITY_REQUIRED","4305","12206","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined intolerance to cows'' milk protein, soy protein and protein hydrolysate formulae</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be older than 24 months of age.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined intolerance to cows'' milk protein, soy protein and protein hydrolysate formulae</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be older than 24 months of age.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12207_4323_R","Initial treatment for up to 6 months","AUTHORITY_REQUIRED","4323","12207","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows'' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows'' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12208_4352_R","Initial treatment for up to 6 months","AUTHORITY_REQUIRED","4352","12208","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cows'' milk protein enteropathy with failure to thrive</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cows'' milk protein enteropathy with failure to thrive</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12209_4339_R","Continuing treatment","AUTHORITY_REQUIRED","4339","12209","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement with initial treatment; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement with initial treatment; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12210_4330_R","null","AUTHORITY_REQUIRED","4330","12210","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk anaphylaxis</p><br/><p>Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction.</p><p/> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk anaphylaxis</p><br/><p>Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction.</p><p/> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12226_4312_R","Initial treatment for up to 6 months","AUTHORITY_REQUIRED","4312","12226","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides); AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven combined immunoglobulin E (IgE) mediated allergy to cows'' milk protein and soy protein</p><br/><p>Initial treatment for up to 6 months</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND</p> <p>Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides); AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12227_12096_R","null","RESTRICTED","12096","12227","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must be undergoing treatment under the strict supervision of a dietitian, together with at least one of: (i) a metabolic physician, (ii) a neurologist; AND</p> <p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must be undergoing treatment under the strict supervision of a dietitian, together with at least one of: (i) a metabolic physician, (ii) a neurologist; AND</p> <p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency.</p> <p align=""justify"">Requests seeking an increased maximum quantity (packs) up to 4 times that stated, may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12230_N","null","null","null","null","null","<p>Not for the treatment of Crohn disease</p>","Y","N","N","null","null","N","2015-03-01","N","4708"
"12237_4337_R","Continuing treatment","AUTHORITY_REQUIRED","4337","12237","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows'' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cows'' milk protein enteropathy</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows'' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12247_4338_R","Continuing treatment","AUTHORITY_REQUIRED","4338","12247","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined intolerance to cows'' milk protein, soy protein and protein hydrolysate formulae</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be older than 24 months of age.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined intolerance to cows'' milk protein, soy protein and protein hydrolysate formulae</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must be older than 24 months of age.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12248_4345_R","Continuing treatment","AUTHORITY_REQUIRED","4345","12248","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cows'' milk protein enteropathy with failure to thrive</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have had failure to thrive prior to commencement with initial treatment; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cows'' milk protein enteropathy with failure to thrive</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists; AND</p> <p>The condition must not be isolated infant colic or reflux; AND</p> <p>Patient must have had failure to thrive prior to commencement with initial treatment; AND</p> <p>Patient must be up to the age of 24 months.</p> <p/><p align=""justify"">The name of the specialist and the date of birth of the patient must be included in the authority application.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12249_12229_R","Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","12229","12249","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have an externally draining enterocutaneous or rectovaginal fistula.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) two completed authority prescription forms; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition of no more than 4 weeks old at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have an externally draining enterocutaneous or rectovaginal fistula.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) two completed authority prescription forms; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition of no more than 4 weeks old at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this biological medicine.</p><p align=""justify""><b>Prescribing the 40 mg presentation:</b></p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats.</p><p align=""justify""><b>Prescribing the 80 mg presentation:</b></p><p align=""justify"">One prescription should be for the 80 mg presentation with a quantity of 3 units and zero repeats. This will enable doses at week 0 and week 2 to be completed. The second prescription should be written for 2 doses of 40 mg and 2 repeats.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2021-09-01","Y","4708"
"12255_4415_R","null","AUTHORITY_REQUIRED","4415","12255","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe intestinal malabsorption including short bowel syndrome</p><br/><p>Patient must have failed to respond to protein hydrolysate formulae; or</p> <p>Patient must have been receiving parenteral nutrition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe intestinal malabsorption including short bowel syndrome</p><br/><p>Patient must have failed to respond to protein hydrolysate formulae; or</p> <p>Patient must have been receiving parenteral nutrition.</p>","N","N","N","IMMEDIATE","ALL","N","2021-09-01","N","4708"
"12270_12270_R","Continuing treatment","STREAMLINED","12270","12270","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months therapy; AND</p> <p>Must be treated by a specialist; or</p> <p>Must be treated by a consultant physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months therapy; AND</p> <p>Must be treated by a specialist; or</p> <p>Must be treated by a consultant physician.</p> <p>Up to a maximum of 18 pens will be reimbursed through the PBS. </p>","N","N","N","IMMEDIATE","ALL","N","2021-10-01","N","4708"
"12304_12271_R","Continuing treatment","STREAMLINED","12271","12304","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III non-small cell lung cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The treatment must not exceed 12 months in total for this condition under the initial and continuing restriction combined; AND</p> <p>The treatment must be once in a lifetime with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III non-small cell lung cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The treatment must not exceed 12 months in total for this condition under the initial and continuing restriction combined; AND</p> <p>The treatment must be once in a lifetime with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2021-10-01","N","4708"
"12335_N","null","null","null","null","null","<p align=""justify"">This drug is not PBS-subsidised for primary prevention of breast cancer.</p>","Y","N","N","null","null","N","2015-03-01","N","4708"
"12336_N","null","null","null","null","null","<p align=""left"">This drug is not PBS-subsidised for adjuvant hormonal treatment of early breast cancer extended beyond 5 years, i.e. a patient who has received 2 years of tamoxifen therapy may only receive 3 years of PBS-subsidised treatment with exemestane.</p>","Y","N","N","null","null","N","2015-03-01","N","4708"
"12349_12349_R","null","STREAMLINED","12349","12349","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months, with significant symptoms despite regular bronchodilator therapy with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonist (LABA) or an inhaled corticosteroid (ICS) and a LABA; or</p> <p>Patient must have been stabilised on a combination of a LAMA, LABA and an ICS for this condition; AND</p> <p>Patient must not be undergoing treatment with this product in each of the following circumstances: (i) treatment of asthma in the absence of a COPD diagnosis, (ii) initiation of bronchodilator therapy in COPD, (iii) use as reliever therapy for asthma, (iv) dosed at an interval/frequency that differs to that recommended in the approved Product Information.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months, with significant symptoms despite regular bronchodilator therapy with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonist (LABA) or an inhaled corticosteroid (ICS) and a LABA; or</p> <p>Patient must have been stabilised on a combination of a LAMA, LABA and an ICS for this condition; AND</p> <p>Patient must not be undergoing treatment with this product in each of the following circumstances: (i) treatment of asthma in the absence of a COPD diagnosis, (ii) initiation of bronchodilator therapy in COPD, (iii) use as reliever therapy for asthma, (iv) dosed at an interval/frequency that differs to that recommended in the approved Product Information.</p>","N","N","N","IMMEDIATE","ALL","N","2021-11-01","N","4708"
"12351_12351_R","Continuing treatment with this drug, or, switching gonadotropin releasing hormone analogue therapy","RESTRICTED","12351","12351","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central precocious puberty</p><br/><p>Continuing treatment with this drug, or, switching gonadotropin releasing hormone analogue therapy</p><br/><p>Must be treated by a medical practitioner identifying as one of: (i) a paediatric endocrinologist, (ii) an endocrinologist specialising in paediatrics; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing continuing treatment with a gonadotropin releasing hormone analogue initiated through the PBS for this PBS indication.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central precocious puberty</p><br/><p>Continuing treatment with this drug, or, switching gonadotropin releasing hormone analogue therapy</p><br/><p>Must be treated by a medical practitioner identifying as one of: (i) a paediatric endocrinologist, (ii) an endocrinologist specialising in paediatrics; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing continuing treatment with a gonadotropin releasing hormone analogue initiated through the PBS for this PBS indication.</p>","N","N","N","IMMEDIATE","ALL","N","2021-11-01","N","4708"
"12369_N","null","null","null","null","null","<p align=""justify"">This drug is not PBS-subsidised for adjuvant hormonal treatment of early breast cancer where the total duration of this drug (or any other aromatase inhibitor) treatment extends beyond 5 years.</p>","Y","N","N","null","null","N","2015-03-01","N","4708"
"12375_N","null","null","null","null","null","<p/><p align=""justify"">Pharmaceutical benefits that have the form ranibizumab 0.165 mL injection syringe and pharmaceutical benefits that have the form ranibizumab 0.23 mL injection vial are equivalent for the purposes of substitution.</p><p/>","Y","N","N","null","null","N","2015-03-01","N","4708"
"12387_12387_R","Initial treatment","RESTRICTED","12387","12387","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central precocious puberty</p><br/><p>Initial treatment</p><br/><p>Must be treated by a paediatric endocrinologist; or</p> <p>Must be treated by an endocrinologist specialising in paediatrics; AND</p> <p>Patient must be of an age that is prior to their 12th birthday if female; or</p> <p>Patient must be of an age that is prior to their 13th birthday if male; AND</p> <p>Patient must have had onset of signs/symptoms of central precocious puberty prior to their 9th birthday if female; or</p> <p>Patient must have had onset of signs/symptoms of central precocious puberty prior to their 10th birthday if male.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central precocious puberty</p><br/><p>Initial treatment</p><br/><p>Must be treated by a paediatric endocrinologist; or</p> <p>Must be treated by an endocrinologist specialising in paediatrics; AND</p> <p>Patient must be of an age that is prior to their 12th birthday if female; or</p> <p>Patient must be of an age that is prior to their 13th birthday if male; AND</p> <p>Patient must have had onset of signs/symptoms of central precocious puberty prior to their 9th birthday if female; or</p> <p>Patient must have had onset of signs/symptoms of central precocious puberty prior to their 10th birthday if male.</p>","N","N","N","IMMEDIATE","ALL","N","2021-11-01","N","4708"
"12394_12392_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","12392","12394","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2021-11-01","N","4708"
"12424_12425_R","Cessation of treatment (all patients)","AUTHORITY_REQUIRED","12425","12424","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Cessation of treatment (all patients)</p><br/><p>Patient must be receiving PBS-subsidised treatment with this PAH agent; AND</p> <p>The treatment must be for the purpose of gradual dose reduction prior to ceasing therapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment. Treatment beyond 1 month will not be approved.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Cessation of treatment (all patients)</p><br/><p>Patient must be receiving PBS-subsidised treatment with this PAH agent; AND</p> <p>The treatment must be for the purpose of gradual dose reduction prior to ceasing therapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment. Treatment beyond 1 month will not be approved.</p>","N","N","N","IMMEDIATE","ALL","N","2021-12-01","N","4708"
"12437_12437_R","null","RESTRICTED","12437","12437","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Wounds</p><br/><p>Patient must have a wound with highly viscous exudate.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Wounds</p><br/><p>Patient must have a wound with highly viscous exudate.</p>","N","N","N","IMMEDIATE","ALL","N","2021-12-01","N","4708"
"12439_12439_R","null","AUTHORITY_REQUIRED","12439","12439","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>The treatment must be used in combination with venetoclax (refer to Product Information for timing of azacitidine and venetoclax doses).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>The treatment must be used in combination with venetoclax (refer to Product Information for timing of azacitidine and venetoclax doses).</p>","N","N","N","IMMEDIATE","ALL","N","2021-12-01","N","4708"
"12440_12440_R","Initial treatment","AUTHORITY_REQUIRED","12440","12440","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable malignant gastrointestinal stromal tumour</p><br/><p>Initial treatment</p><br/><p>The condition must not be resectable; AND</p> <p>The treatment must be as monotherapy; AND</p> <p>The condition must have progressed despite treatment with all drugs PBS-listed specifically for this PBS-indication; or</p> <p>The condition must have progressed despite each of: (i) treatment with a drug PBS-listed specifically listed for this PBS-indication, (ii) an intolerance/expected intolerance to all other drugs PBS-listed for this specific PBS-indication; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must be undergoing PBS-subsidised treatment with this drug for the first time - retreatment/continuing treatment beyond the available repeat prescription is not permitted under this listing; see ''Continuing treatment'' Treatment Phase listing to continue PBS-subsidised treatment in a patient without disease progression.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable malignant gastrointestinal stromal tumour</p><br/><p>Initial treatment</p><br/><p>The condition must not be resectable; AND</p> <p>The treatment must be as monotherapy; AND</p> <p>The condition must have progressed despite treatment with all drugs PBS-listed specifically for this PBS-indication; or</p> <p>The condition must have progressed despite each of: (i) treatment with a drug PBS-listed specifically listed for this PBS-indication, (ii) an intolerance/expected intolerance to all other drugs PBS-listed for this specific PBS-indication; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must be undergoing PBS-subsidised treatment with this drug for the first time - retreatment/continuing treatment beyond the available repeat prescription is not permitted under this listing; see ''Continuing treatment'' Treatment Phase listing to continue PBS-subsidised treatment in a patient without disease progression.</p> <p align=""justify"">Currently PBS-listed drugs with the indication of: &apos;metastatic or unresectable malignant gastrointestinal stromal tumour&apos; are: imatinib and sunitinib</p>","N","N","N","IMMEDIATE","ALL","N","2021-12-01","N","4708"
"12455_12455_R","Continuing treatment","AUTHORITY_REQUIRED","12455","12455","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable malignant gastrointestinal stromal tumour</p><br/><p>Continuing treatment</p><br/><p>The condition must not be resectable; AND</p> <p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be as monotherapy; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable malignant gastrointestinal stromal tumour</p><br/><p>Continuing treatment</p><br/><p>The condition must not be resectable; AND</p> <p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be as monotherapy; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2021-12-01","N","4708"
"12459_12459_R","null","AUTHORITY_REQUIRED","12459","12459","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency; AND</p> <p>Patient must have severe intestinal malabsorption of whole protein ketogenic diet formula; AND</p> <p>Patient must have unsuccessfully trialled at least one of the PBS-listed products with the indication of: ''Ketogenic diet''.</p> <p align=""justify"">This product must only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency; AND</p> <p>Patient must have severe intestinal malabsorption of whole protein ketogenic diet formula; AND</p> <p>Patient must have unsuccessfully trialled at least one of the PBS-listed products with the indication of: ''Ketogenic diet''.</p> <p align=""justify"">This product must only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist.</p>","N","N","N","IMMEDIATE","ALL","N","2021-12-01","N","4708"
"12470_12470_R","Continuing treatment","STREAMLINED","12470","12470","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>The treatment must be in combination with PBS-subsidised encorafenib for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>The treatment must be in combination with PBS-subsidised encorafenib for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2022-01-01","N","4708"
"12478_12490_R","Initial treatment","AUTHORITY_REQUIRED","12490","12478","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Refractory follicular B-cell non-Hodgkin''s lymphoma</p><br/><p>Initial treatment</p><br/><p>The condition must be refractory to a prior therapy with rituximab within 6 months after completion of treatment with rituximab; AND</p> <p>The condition must be refractory to a prior therapy with an alkylating agent within 6 months after completion of treatment with an alkylating agent; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">The condition is considered refractory to a prior therapy when the patient experiences less than a partial response or progression of disease within 6 months after completion of the prior therapy.</p> <p align=""justify"">The condition is considered refractory to both rituximab and an alkylating agent if the agents were administered together or in successive treatment regimens.</p> <p align=""justify"">The date of completion of prior therapies with rituximab and an alkylating agent must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Refractory follicular B-cell non-Hodgkin''s lymphoma</p><br/><p>Initial treatment</p><br/><p>The condition must be refractory to a prior therapy with rituximab within 6 months after completion of treatment with rituximab; AND</p> <p>The condition must be refractory to a prior therapy with an alkylating agent within 6 months after completion of treatment with an alkylating agent; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">The condition is considered refractory to a prior therapy when the patient experiences less than a partial response or progression of disease within 6 months after completion of the prior therapy.</p> <p align=""justify"">The condition is considered refractory to both rituximab and an alkylating agent if the agents were administered together or in successive treatment regimens.</p> <p align=""justify"">The date of completion of prior therapies with rituximab and an alkylating agent must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2022-01-01","N","4708"
"12483_12483_R","Initial treatment","STREAMLINED","12483","12483","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>The treatment must be in combination with PBS-subsidised encorafenib for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>The treatment must be in combination with PBS-subsidised encorafenib for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2022-01-01","N","4708"
"12484_12484_R","Continuing treatment","STREAMLINED","12484","12484","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with cetuximab; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with cetuximab; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2022-01-01","N","4708"
"12487_12487_R","Initial treatment","STREAMLINED","12487","12487","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have BRAF V600 variant positive metastatic colorectal cancer; AND</p> <p>The treatment must be in combination with cetuximab; AND</p> <p>Patient must not have received prior treatment with cetuximab for this condition; or</p> <p>Patient must not have developed disease progression while receiving cetuximab for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must have failed to respond to at least one other line of systemic therapy; AND</p> <p>Patient must have a WHO performance status of 2 or less.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have BRAF V600 variant positive metastatic colorectal cancer; AND</p> <p>The treatment must be in combination with cetuximab; AND</p> <p>Patient must not have received prior treatment with cetuximab for this condition; or</p> <p>Patient must not have developed disease progression while receiving cetuximab for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must have failed to respond to at least one other line of systemic therapy; AND</p> <p>Patient must have a WHO performance status of 2 or less.</p>","N","N","N","IMMEDIATE","ALL","N","2022-01-01","N","4708"
"12493_12493_R","Continuing or resuming treatment with this drug of the whole body","AUTHORITY_REQUIRED","12493","12493","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Continuing or resuming treatment with this drug of the whole body</p><br/><p>Patient must have received PBS-subsidised treatment with this therapy for the treatment of chronic severe atopic dermatitis affecting the whole body; AND</p> <p>Patient must have achieved an adequate response prior to this first continuing treatment authority application; or</p> <p>Patient must have maintained an adequate response to their most recent supply of this therapy for this PBS indication if this is any Continuing treatment authority application other than the first; or</p> <p>Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis).</p> <p align=""justify"">For the purposes of this restriction, an adequate response to treatment is defined as:</p><p align=""justify"">(a) An improvement/maintenance in the Eczema Area and Severity Index (EASI) score of at least 50% compared to baseline; and</p><p align=""justify"">(b) An improvement/maintenance in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline</p><p align=""justify"">Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the &apos;Grandfather listing&apos; authority application will suffice as an adequate response for requirement (b) above.</p><p align=""justify"">State each of the current EASI and DLQI scores for this authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Continuing or resuming treatment with this drug of the whole body</p><br/><p>Patient must have received PBS-subsidised treatment with this therapy for the treatment of chronic severe atopic dermatitis affecting the whole body; AND</p> <p>Patient must have achieved an adequate response prior to this first continuing treatment authority application; or</p> <p>Patient must have maintained an adequate response to their most recent supply of this therapy for this PBS indication if this is any Continuing treatment authority application other than the first; or</p> <p>Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis).</p> <p align=""justify"">For the purposes of this restriction, an adequate response to treatment is defined as:</p><p align=""justify"">(a) An improvement/maintenance in the Eczema Area and Severity Index (EASI) score of at least 50% compared to baseline; and</p><p align=""justify"">(b) An improvement/maintenance in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline</p><p align=""justify"">Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the &apos;Grandfather listing&apos; authority application will suffice as an adequate response for requirement (b) above.</p><p align=""justify"">State each of the current EASI and DLQI scores for this authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2022-02-01","N","4708"
"12494_12494_R","Continuing or resuming treatment with this drug of the face and/or hands","AUTHORITY_REQUIRED","12494","12494","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Continuing or resuming treatment with this drug of the face and/or hands</p><br/><p>Patient must have received PBS-subsidised treatment with this therapy for the treatment of chronic severe atopic dermatitis affecting the face/hands; AND</p> <p>Patient must have achieved an adequate response prior to this first continuing treatment authority application; or</p> <p>Patient must have maintained an adequate response to their most recent supply of this therapy for this PBS indication if this is any Continuing treatment authority application other than the first; or</p> <p>Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis).</p> <p align=""justify"">For the purposes of this restriction, an adequate response to treatment of the face/hands is defined as:</p><p align=""justify"">(a) (i) A rating of either mild (1) to none (0) on at least 3 of the assessments of erythema, oedema/papulation, excoriation and lichenification mentioned in the Eczema Area and Severity Index (EASI); or</p><p align=""justify"">(ii) At least a 75% reduction in the skin area affected by this condition compared to baseline; and</p><p align=""justify"">(b) An improvement in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline</p><p align=""justify"">Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the &apos;Grandfather listing&apos; authority application will suffice as an adequate response for requirement (b) above.</p><p align=""justify"">Document each qualifying response measure in the patient&apos;s medical records for PBS compliance auditing purposes</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Continuing or resuming treatment with this drug of the face and/or hands</p><br/><p>Patient must have received PBS-subsidised treatment with this therapy for the treatment of chronic severe atopic dermatitis affecting the face/hands; AND</p> <p>Patient must have achieved an adequate response prior to this first continuing treatment authority application; or</p> <p>Patient must have maintained an adequate response to their most recent supply of this therapy for this PBS indication if this is any Continuing treatment authority application other than the first; or</p> <p>Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis).</p> <p align=""justify"">For the purposes of this restriction, an adequate response to treatment of the face/hands is defined as:</p><p align=""justify"">(a) (i) A rating of either mild (1) to none (0) on at least 3 of the assessments of erythema, oedema/papulation, excoriation and lichenification mentioned in the Eczema Area and Severity Index (EASI); or</p><p align=""justify"">(ii) At least a 75% reduction in the skin area affected by this condition compared to baseline; and</p><p align=""justify"">(b) An improvement in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline</p><p align=""justify"">Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the &apos;Grandfather listing&apos; authority application will suffice as an adequate response for requirement (b) above.</p><p align=""justify"">Document each qualifying response measure in the patient&apos;s medical records for PBS compliance auditing purposes</p>","N","N","N","IMMEDIATE","ALL","N","2022-02-01","N","4708"
"12499_12499_R","Initial treatment with this drug of the whole body","AUTHORITY_REQUIRED","12499","12499","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Initial treatment with this drug of the whole body</p><br/><p>Patient must have a Physicians Global Assessment (PGA) (5-point scale) baseline score of at least 4 as evidence of severe disease despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>Patient must have an Eczema Area and Severity Index (EASI) baseline score of at least 20 despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND</p> <p>Patient must not have experienced an inadequate response to this therapy; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis); AND</p> <p>Patient must be 12 years of age or older.</p> <p align=""justify"">State each of the qualifying (i) PGA, (ii) EASI and (iii) DLQI scores in the authority application.</p><p align=""justify"">Acceptable scores can be:</p><p align=""justify"">(a) current scores; or</p><p align=""justify"">(b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.</p><p align=""justify"">The EASI and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient&apos;s medical records.</p><p align=""justify"">Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Initial treatment with this drug of the whole body</p><br/><p>Patient must have a Physicians Global Assessment (PGA) (5-point scale) baseline score of at least 4 as evidence of severe disease despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>Patient must have an Eczema Area and Severity Index (EASI) baseline score of at least 20 despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND</p> <p>Patient must not have experienced an inadequate response to this therapy; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis); AND</p> <p>Patient must be 12 years of age or older.</p> <p align=""justify"">State each of the qualifying (i) PGA, (ii) EASI and (iii) DLQI scores in the authority application.</p><p align=""justify"">Acceptable scores can be:</p><p align=""justify"">(a) current scores; or</p><p align=""justify"">(b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.</p><p align=""justify"">The EASI and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient&apos;s medical records.</p><p align=""justify"">Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2022-02-01","N","4708"
"12504_12504_R","Dose change (increasing up to the 30 mg dose, or, decreasing back down to the 15 mg dose) - whole body, or, face/hands","AUTHORITY_REQUIRED","12504","12504","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Dose change (increasing up to the 30 mg dose, or, decreasing back down to the 15 mg dose) - whole body, or, face/hands</p><br/><p>Patient must not be undergoing each of: (i) commencing treatment through this treatment phase listing, (ii) treatment accessed through this treatment phase on more than 2 consecutive occasions; AND</p> <p>Patient must be undergoing existing PBS-subsidised treatment with this therapy where each of the following is true: (i) there is a change in daily dose, (ii) any remaining PBS repeat prescriptions for the strength that the patient is changing from, is marked as ''cancelled''; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Dose change (increasing up to the 30 mg dose, or, decreasing back down to the 15 mg dose) - whole body, or, face/hands</p><br/><p>Patient must not be undergoing each of: (i) commencing treatment through this treatment phase listing, (ii) treatment accessed through this treatment phase on more than 2 consecutive occasions; AND</p> <p>Patient must be undergoing existing PBS-subsidised treatment with this therapy where each of the following is true: (i) there is a change in daily dose, (ii) any remaining PBS repeat prescriptions for the strength that the patient is changing from, is marked as ''cancelled''; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis).</p>","N","N","N","IMMEDIATE","ALL","N","2022-02-01","N","4708"
"12508_12508_R","Initial treatment with this drug of the face and/or hands","AUTHORITY_REQUIRED","12508","12508","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Initial treatment with this drug of the face and/or hands</p><br/><p>The condition must have at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub-scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; or</p> <p>The condition must have affected at least 30% of the face/hands surface area despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND</p> <p>Patient must not have experienced an inadequate response to this therapy; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis); AND</p> <p>Patient must be 12 years of age or older.</p> <p align=""justify"">State each of the 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) for:</p><p align=""justify"">(i) erythema,</p><p align=""justify"">(ii) oedema/papulation,</p><p align=""justify"">(iii) excoriation,</p><p align=""justify"">(iv) lichenification</p><p align=""justify"">Acceptable scores can be:</p><p align=""justify"">(a) current scores; or</p><p align=""justify"">(b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.</p><p align=""justify"">State the percentage face/hand surface area affected by the condition (must be at least 30%) where EASI symptom sub-scores are not provided. This percentage surface area can also be stated in addition to the EASI symptom sub-scores.</p><p align=""justify"">The EASI/percentage surface area and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient&apos;s medical records.</p><p align=""justify"">Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled are in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Initial treatment with this drug of the face and/or hands</p><br/><p>The condition must have at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub-scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; or</p> <p>The condition must have affected at least 30% of the face/hands surface area despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND</p> <p>Patient must not have experienced an inadequate response to this therapy; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis); AND</p> <p>Patient must be 12 years of age or older.</p> <p align=""justify"">State each of the 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) for:</p><p align=""justify"">(i) erythema,</p><p align=""justify"">(ii) oedema/papulation,</p><p align=""justify"">(iii) excoriation,</p><p align=""justify"">(iv) lichenification</p><p align=""justify"">Acceptable scores can be:</p><p align=""justify"">(a) current scores; or</p><p align=""justify"">(b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.</p><p align=""justify"">State the percentage face/hand surface area affected by the condition (must be at least 30%) where EASI symptom sub-scores are not provided. This percentage surface area can also be stated in addition to the EASI symptom sub-scores.</p><p align=""justify"">The EASI/percentage surface area and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient&apos;s medical records.</p><p align=""justify"">Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled are in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2022-02-01","N","4708"
"12520_12561_R","Initial treatment - third-line therapy","AUTHORITY_REQUIRED","12561","12520","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - third-line therapy</p><br/><p>The condition must be in the chronic phase; or</p> <p>The condition must be in the accelerated phase; or</p> <p>The condition must be in the blast phase; AND</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; or</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the second-line setting; AND</p> <p>Patient must have documented failure with an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; AND</p> <p>Patient must have failed an adequate trial of PBS-subsidised second-line treatment with nilotinib for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Failure of an adequate trial of nilotinib is defined as:</p><p align=""justify"">(i) Lack of response to second line nilotinib therapy, defined as either:</p><p align=""justify"">- failure to achieve a haematological response after a minimum of 3 months therapy with nilotinib for patients initially treated in chronic phase; or</p><p align=""justify"">- failure to achieve any cytogenetic response after a minimum of 6 months therapy with nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or</p><p align=""justify"">- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with nilotinib; OR</p><p align=""justify"">ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing nilotinib therapy; OR</p><p align=""justify"">(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing nilotinib therapy; OR</p><p align=""justify"">(iv) Development of accelerated phase or blast crisis in a patient previously prescribed nilotinib for any phase of chronic myeloid leukaemia.</p><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p align=""justify"">(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p align=""justify"">(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or</p><p align=""justify"">(3) Peripheral basophils greater than or equal to 20%; or</p><p align=""justify"">(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or</p><p align=""justify"">(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR</p><p align=""justify"">Blast crisis is defined as either:</p><p align=""justify"">(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or</p><p align=""justify"">(2) Extramedullary involvement other than spleen and liver; OR</p><p align=""justify"">(v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.</p> <p align=""justify"">Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals.</p> <p align=""justify"">A bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale either on peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Pathology report(s) confirming a loss of response to imatinib and nilotinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - third-line therapy</p><br/><p>The condition must be in the chronic phase; or</p> <p>The condition must be in the accelerated phase; or</p> <p>The condition must be in the blast phase; AND</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; or</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the second-line setting; AND</p> <p>Patient must have documented failure with an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; AND</p> <p>Patient must have failed an adequate trial of PBS-subsidised second-line treatment with nilotinib for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Failure of an adequate trial of nilotinib is defined as:</p><p align=""justify"">(i) Lack of response to second line nilotinib therapy, defined as either:</p><p align=""justify"">- failure to achieve a haematological response after a minimum of 3 months therapy with nilotinib for patients initially treated in chronic phase; or</p><p align=""justify"">- failure to achieve any cytogenetic response after a minimum of 6 months therapy with nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or</p><p align=""justify"">- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with nilotinib; OR</p><p align=""justify"">ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing nilotinib therapy; OR</p><p align=""justify"">(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing nilotinib therapy; OR</p><p align=""justify"">(iv) Development of accelerated phase or blast crisis in a patient previously prescribed nilotinib for any phase of chronic myeloid leukaemia.</p><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p align=""justify"">(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p align=""justify"">(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or</p><p align=""justify"">(3) Peripheral basophils greater than or equal to 20%; or</p><p align=""justify"">(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or</p><p align=""justify"">(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR</p><p align=""justify"">Blast crisis is defined as either:</p><p align=""justify"">(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or</p><p align=""justify"">(2) Extramedullary involvement other than spleen and liver; OR</p><p align=""justify"">(v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.</p> <p align=""justify"">Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals.</p> <p align=""justify"">A bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale either on peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Pathology report(s) confirming a loss of response to imatinib and nilotinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12526_12527_R","Initial treatment - first-line therapy","AUTHORITY_REQUIRED","12527","12526","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - first-line therapy</p><br/><p>The condition must be a primary diagnosis of chronic myeloid leukaemia; AND</p> <p>The condition must be in the accelerated phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must not have previously experienced a failure to respond to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p/><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p/><p align=""justify"">2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or </p><p/><p align=""justify"">3. Peripheral basophils greater than or equal to 20%; or</p><p/><p align=""justify"">4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or </p><p/><p align=""justify"">5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).</p><p/> <p align=""justify"">A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - first-line therapy</p><br/><p>The condition must be a primary diagnosis of chronic myeloid leukaemia; AND</p> <p>The condition must be in the accelerated phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must not have previously experienced a failure to respond to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p/><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p/><p align=""justify"">2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or </p><p/><p align=""justify"">3. Peripheral basophils greater than or equal to 20%; or</p><p/><p align=""justify"">4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or </p><p/><p align=""justify"">5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).</p><p/> <p align=""justify"">A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12528_12529_R","Initial treatment - second-line therapy","AUTHORITY_REQUIRED","12529","12528","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - second-line therapy</p><br/><p>The condition must be in the chronic phase; or</p> <p>The condition must be in the accelerated phase; AND</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; AND</p> <p>Patient must have failed an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; or</p> <p>Patient must have failed an adequate trial of PBS-subsidised first-line treatment with dasatinib for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with dasatinib for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Failure of an adequate trial of imatinib or dasatinib is defined as:</p><p align=""justify"">(i) Lack of response to initial imatinib or dasatinib therapy, defined as either:</p><p align=""justify"">- failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib for patients initially treated in chronic phase; or</p><p align=""justify"">- failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or</p><p align=""justify"">- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib; OR</p><p align=""justify"">(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib therapy; OR</p><p align=""justify"">(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib therapy; OR</p><p align=""justify"">(iv) Development of accelerated phase in a patient previously prescribed imatinib or dasatinib for the chronic phase of chronic myeloid leukaemia.</p><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p align=""justify"">(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p align=""justify"">(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or</p><p align=""justify"">(3) Peripheral basophils greater than or equal to 20%; or</p><p align=""justify"">(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or</p><p align=""justify"">(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR</p><p align=""justify"">(v) Disease progression (defined as a greater than or equal to.</p><p align=""justify"">50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or dasatinib therapy in patients with accelerated phase chronic myeloid leukaemia, provided that blast crisis has been excluded on bone marrow biopsy.</p> <p align=""justify"">Patients should be commenced on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to nilotinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals.</p> <p align=""justify"">A bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale either on peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Pathology report(s) confirming a loss of response to imatinib or dasatinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - second-line therapy</p><br/><p>The condition must be in the chronic phase; or</p> <p>The condition must be in the accelerated phase; AND</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; AND</p> <p>Patient must have failed an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; or</p> <p>Patient must have failed an adequate trial of PBS-subsidised first-line treatment with dasatinib for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with dasatinib for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Failure of an adequate trial of imatinib or dasatinib is defined as:</p><p align=""justify"">(i) Lack of response to initial imatinib or dasatinib therapy, defined as either:</p><p align=""justify"">- failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib for patients initially treated in chronic phase; or</p><p align=""justify"">- failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or</p><p align=""justify"">- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib; OR</p><p align=""justify"">(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib therapy; OR</p><p align=""justify"">(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib therapy; OR</p><p align=""justify"">(iv) Development of accelerated phase in a patient previously prescribed imatinib or dasatinib for the chronic phase of chronic myeloid leukaemia.</p><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p align=""justify"">(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p align=""justify"">(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or</p><p align=""justify"">(3) Peripheral basophils greater than or equal to 20%; or</p><p align=""justify"">(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or</p><p align=""justify"">(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR</p><p align=""justify"">(v) Disease progression (defined as a greater than or equal to.</p><p align=""justify"">50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or dasatinib therapy in patients with accelerated phase chronic myeloid leukaemia, provided that blast crisis has been excluded on bone marrow biopsy.</p> <p align=""justify"">Patients should be commenced on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to nilotinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals.</p> <p align=""justify"">A bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale either on peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Pathology report(s) confirming a loss of response to imatinib or dasatinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12531_12531_R","Continuing treatment","STREAMLINED","12531","12531","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic graft versus host disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received, at anytime prior to this pharmaceutical benefit within the same treatment episode, both: (i) this drug subsidised through the Initial treatment listing, (ii) the extracorporeal photopheresis-MBS benefit for initial treatment; AND</p> <p>Patient must have demonstrated a response to initial treatment with this drug (administered as part of MBS-subsidised extracorporeal photopheresis treatment) obtained through this drug''s ''Initial treatment'' PBS-listing for the same treatment episode; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition; AND</p> <p>Patient must not be undergoing re-treatment through this treatment phase immediately following a relapse - see ''Initial treatment'' for resuming treatment following relapse.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic graft versus host disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received, at anytime prior to this pharmaceutical benefit within the same treatment episode, both: (i) this drug subsidised through the Initial treatment listing, (ii) the extracorporeal photopheresis-MBS benefit for initial treatment; AND</p> <p>Patient must have demonstrated a response to initial treatment with this drug (administered as part of MBS-subsidised extracorporeal photopheresis treatment) obtained through this drug''s ''Initial treatment'' PBS-listing for the same treatment episode; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition; AND</p> <p>Patient must not be undergoing re-treatment through this treatment phase immediately following a relapse - see ''Initial treatment'' for resuming treatment following relapse.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12539_12570_R","Initial treatment - first-line therapy","AUTHORITY_REQUIRED","12570","12539","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - first-line therapy</p><br/><p>Patient must have a primary diagnosis of chronic myeloid leukaemia; AND</p> <p>The condition must be in the chronic phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must not have previously experienced a failure to respond to PBS-subsidised first-line treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first-line therapy for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.</p><p align=""justify"">Patients should be commenced on a dose of dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.</p> <p align=""justify"">A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - first-line therapy</p><br/><p>Patient must have a primary diagnosis of chronic myeloid leukaemia; AND</p> <p>The condition must be in the chronic phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must not have previously experienced a failure to respond to PBS-subsidised first-line treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first-line therapy for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.</p><p align=""justify"">Patients should be commenced on a dose of dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.</p> <p align=""justify"">A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12540_12541_R","Initial treatment - first-line therapy","AUTHORITY_REQUIRED","12541","12540","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - first-line therapy</p><br/><p>The condition must be a primary diagnosis of chronic myeloid leukaemia; AND</p> <p>The condition must be in the chronic phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must not have previously experienced a failure to respond to PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first-line therapy for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.</p><p align=""justify"">Patients should be commenced on a dose of imatinib mesilate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesilate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.</p> <p align=""justify"">A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - first-line therapy</p><br/><p>The condition must be a primary diagnosis of chronic myeloid leukaemia; AND</p> <p>The condition must be in the chronic phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must not have previously experienced a failure to respond to PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first-line therapy for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.</p><p align=""justify"">Patients should be commenced on a dose of imatinib mesilate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesilate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.</p> <p align=""justify"">A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12546_12546_R","Initial treatment in a treatment episode","STREAMLINED","12546","12546","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic graft versus host disease</p><br/><p>Initial treatment in a treatment episode</p><br/><p>The condition must be inadequately responsive to systemic corticosteroid treatment at a therapeutic dose, but has never been treated with this drug; or</p> <p>The condition must have relapsed within 8 weeks of prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis; or</p> <p>The condition must have relapsed with each of the following conditions being met: (i) prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis last occurred at least 8 weeks ago, (ii) a subsequent trial of systemic corticosteroids at therapeutic doses has been completed; AND</p> <p>Patient must be undergoing treatment with this drug that is being administered within at least one of: (i) the first 12 weeks of a treatment episode, (ii) the first 25 doses (inclusive of the 25th dose) of a treatment episode; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation; AND</p> <p>Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic graft versus host disease</p><br/><p>Initial treatment in a treatment episode</p><br/><p>The condition must be inadequately responsive to systemic corticosteroid treatment at a therapeutic dose, but has never been treated with this drug; or</p> <p>The condition must have relapsed within 8 weeks of prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis; or</p> <p>The condition must have relapsed with each of the following conditions being met: (i) prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis last occurred at least 8 weeks ago, (ii) a subsequent trial of systemic corticosteroids at therapeutic doses has been completed; AND</p> <p>Patient must be undergoing treatment with this drug that is being administered within at least one of: (i) the first 12 weeks of a treatment episode, (ii) the first 25 doses (inclusive of the 25th dose) of a treatment episode; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation; AND</p> <p>Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12549_12549_R","Grandfather treatment for patients initiated with nilotinib 200 mg prior to 1 April 2012 as first-line therapy","STREAMLINED","12549","12549","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Grandfather treatment for patients initiated with nilotinib 200 mg prior to 1 April 2012 as first-line therapy</p><br/><p>The condition must be in the chronic phase; AND</p> <p>Patient must have received PBS-subsidised treatment with nilotinib 200mg as a first-line therapy for this condition prior to 1 April 2012; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Grandfather treatment for patients initiated with nilotinib 200 mg prior to 1 April 2012 as first-line therapy</p><br/><p>The condition must be in the chronic phase; AND</p> <p>Patient must have received PBS-subsidised treatment with nilotinib 200mg as a first-line therapy for this condition prior to 1 April 2012; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12550_12569_R","Initial treatment - third-line therapy","AUTHORITY_REQUIRED","12569","12550","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - third-line therapy</p><br/><p>The condition must be in the chronic phase; or</p> <p>The condition must be in the accelerated phase; AND</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; or</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the second-line setting; AND</p> <p>Patient must have documented failure with an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; AND</p> <p>Patient must have failed an adequate trial of PBS-subsidised second-line treatment with dasatinib for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Failure of an adequate trial of dasatinib is defined as:</p><p align=""justify"">(i) Lack of response to second-line dasatinib therapy, defined as either:</p><p align=""justify"">- failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib for patients initially treated in chronic phase; or</p><p align=""justify"">- failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or</p><p align=""justify"">- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib; OR</p><p align=""justify"">(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib therapy; OR</p><p align=""justify"">(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib therapy; OR</p><p align=""justify"">(iv) Development of accelerated phase in a patient previously prescribed dasatinib for the chronic phase of chronic myeloid leukaemia.<br/>Accelerated phase is defined by the presence of 1 or more of the following:</p><p align=""justify"">(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p align=""justify"">(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or</p><p align=""justify"">(3) Peripheral basophils greater than or equal to 20%; or</p><p align=""justify"">(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or</p><p align=""justify"">(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR</p><p align=""justify"">(v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib therapy in patients with accelerated phase chronic myeloid leukaemia, provided that blast crisis has been excluded on bone marrow biopsy.</p> <p align=""justify"">Patients should be commenced on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to nilotinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals.</p> <p align=""justify"">A bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale either on peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Pathology report(s) confirming a loss of response to imatinib and dasatinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - third-line therapy</p><br/><p>The condition must be in the chronic phase; or</p> <p>The condition must be in the accelerated phase; AND</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; or</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the second-line setting; AND</p> <p>Patient must have documented failure with an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; AND</p> <p>Patient must have failed an adequate trial of PBS-subsidised second-line treatment with dasatinib for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Failure of an adequate trial of dasatinib is defined as:</p><p align=""justify"">(i) Lack of response to second-line dasatinib therapy, defined as either:</p><p align=""justify"">- failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib for patients initially treated in chronic phase; or</p><p align=""justify"">- failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or</p><p align=""justify"">- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib; OR</p><p align=""justify"">(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib therapy; OR</p><p align=""justify"">(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib therapy; OR</p><p align=""justify"">(iv) Development of accelerated phase in a patient previously prescribed dasatinib for the chronic phase of chronic myeloid leukaemia.<br/>Accelerated phase is defined by the presence of 1 or more of the following:</p><p align=""justify"">(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p align=""justify"">(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or</p><p align=""justify"">(3) Peripheral basophils greater than or equal to 20%; or</p><p align=""justify"">(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or</p><p align=""justify"">(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); OR</p><p align=""justify"">(v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib therapy in patients with accelerated phase chronic myeloid leukaemia, provided that blast crisis has been excluded on bone marrow biopsy.</p> <p align=""justify"">Patients should be commenced on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to nilotinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals.</p> <p align=""justify"">A bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale either on peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Pathology report(s) confirming a loss of response to imatinib and dasatinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12554_12524_R","Initial treatment - second-line therapy","AUTHORITY_REQUIRED","12524","12554","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - second-line therapy</p><br/><p>The condition must be in the chronic phase; or</p> <p>The condition must be in the accelerated phase; or</p> <p>The condition must be in the blast phase; AND</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; AND</p> <p>Patient must have failed an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; or</p> <p>Patient must have failed an adequate trial of PBS-subsidised first-line treatment with nilotinib for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with nilotinib for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Failure of an adequate trial of imatinib or nilotinib is defined as:</p><p align=""justify"">(i) Lack of response to initial imatinib or nilotinib therapy, defined as either:</p><p align=""justify"">- failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or nilotinib for patients initially treated in chronic phase; or</p><p align=""justify"">- failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or</p><p align=""justify"">- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or nilotinib; OR</p><p align=""justify"">(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or nilotinib therapy; OR</p><p align=""justify"">(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or nilotinib therapy; OR</p><p align=""justify"">(iv) Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or nilotinib for any phase of chronic myeloid leukaemia.</p><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p align=""justify"">(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p align=""justify"">(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or</p><p align=""justify"">(3) Peripheral basophils greater than or equal to 20%; or</p><p align=""justify"">(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or</p><p align=""justify"">(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome);</p><p align=""justify"">Blast crisis is defined as either:</p><p align=""justify"">(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or</p><p align=""justify"">(2) Extramedullary involvement other than spleen and liver; OR</p><p align=""justify"">(v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.</p> <p align=""justify"">Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals.</p> <p align=""justify"">A bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale either on peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Pathology report(s) confirming a loss of response to imatinib or nilotinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - second-line therapy</p><br/><p>The condition must be in the chronic phase; or</p> <p>The condition must be in the accelerated phase; or</p> <p>The condition must be in the blast phase; AND</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting; AND</p> <p>Patient must have failed an adequate trial of PBS-subsidised first-line treatment with imatinib for this condition; or</p> <p>Patient must have failed an adequate trial of PBS-subsidised first-line treatment with nilotinib for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with nilotinib for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Failure of an adequate trial of imatinib or nilotinib is defined as:</p><p align=""justify"">(i) Lack of response to initial imatinib or nilotinib therapy, defined as either:</p><p align=""justify"">- failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or nilotinib for patients initially treated in chronic phase; or</p><p align=""justify"">- failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or nilotinib for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or</p><p align=""justify"">- failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or nilotinib; OR</p><p align=""justify"">(ii) Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or nilotinib therapy; OR</p><p align=""justify"">(iii) Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or nilotinib therapy; OR</p><p align=""justify"">(iv) Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or nilotinib for any phase of chronic myeloid leukaemia.</p><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p align=""justify"">(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p align=""justify"">(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or</p><p align=""justify"">(3) Peripheral basophils greater than or equal to 20%; or</p><p align=""justify"">(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or</p><p align=""justify"">(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome);</p><p align=""justify"">Blast crisis is defined as either:</p><p align=""justify"">(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or</p><p align=""justify"">(2) Extramedullary involvement other than spleen and liver; OR</p><p align=""justify"">(v) Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first-line imatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.</p> <p align=""justify"">Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR-ABL level of less than 1% within 18 months and thereafter at 12 monthly intervals.</p> <p align=""justify"">A bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale either on peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Pathology report(s) confirming a loss of response to imatinib or nilotinib, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12556_12543_R","Initial treatment - first-line therapy","AUTHORITY_REQUIRED","12543","12556","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - first-line therapy</p><br/><p>The condition must be a primary diagnosis of chronic myeloid leukaemia; AND</p> <p>The condition must be in the blast phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must not have previously experienced a failure to respond to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Blast crisis is defined as either:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or</p><p/><p align=""justify"">2. Extramedullary involvement other than spleen and liver.</p><p/> <p align=""justify"">A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - first-line therapy</p><br/><p>The condition must be a primary diagnosis of chronic myeloid leukaemia; AND</p> <p>The condition must be in the blast phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must not have previously experienced a failure to respond to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Blast crisis is defined as either:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or</p><p/><p align=""justify"">2. Extramedullary involvement other than spleen and liver.</p><p/> <p align=""justify"">A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12559_12559_R","Induction treatment","AUTHORITY_REQUIRED","12559","12559","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Induction treatment</p><br/><p>Patient must have confirmed CD33-positive AML prior to initiation of treatment; AND</p> <p>The condition must be de novo; AND</p> <p>The condition must be previously untreated at the time of initiation (except for prior essential treatment with hydroxyurea or leukapheresis for patients with hyperleukocytic AML); AND</p> <p>Patient must have confirmed intermediate/favourable cytogenetic risk; or</p> <p>Patient must have unknown cytogenetic risk due to inconclusive test results; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>The condition must not be acute promyelocytic leukaemia; AND</p> <p>The treatment must be in combination with standard intensive remission induction chemotherapy for this condition, which must include cytarabine and an anthracycline; AND</p> <p>The treatment must not be used in combination with a tyrosine kinase inhibitor; AND</p> <p>The condition must not be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive; AND</p> <p>Patient must not receive more than 1 induction cycle under this restriction in a lifetime.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Induction treatment</p><br/><p>Patient must have confirmed CD33-positive AML prior to initiation of treatment; AND</p> <p>The condition must be de novo; AND</p> <p>The condition must be previously untreated at the time of initiation (except for prior essential treatment with hydroxyurea or leukapheresis for patients with hyperleukocytic AML); AND</p> <p>Patient must have confirmed intermediate/favourable cytogenetic risk; or</p> <p>Patient must have unknown cytogenetic risk due to inconclusive test results; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>The condition must not be acute promyelocytic leukaemia; AND</p> <p>The treatment must be in combination with standard intensive remission induction chemotherapy for this condition, which must include cytarabine and an anthracycline; AND</p> <p>The treatment must not be used in combination with a tyrosine kinase inhibitor; AND</p> <p>The condition must not be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive; AND</p> <p>Patient must not receive more than 1 induction cycle under this restriction in a lifetime.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12564_12557_R","Initial treatment - first-line therapy","AUTHORITY_REQUIRED","12557","12564","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - first-line therapy</p><br/><p>Patient must have a primary diagnosis of chronic myeloid leukaemia; AND</p> <p>The condition must be in the chronic phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must not have previously experienced a failure to respond to PBS-subsidised first-line treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first-line therapy for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.<br/>Patients should be commenced on a dose of nilotinib of 300 mg twice daily. Continuing therapy is dependent on patients demonstrating a response to nilotinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.</p> <p align=""justify"">A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment - first-line therapy</p><br/><p>Patient must have a primary diagnosis of chronic myeloid leukaemia; AND</p> <p>The condition must be in the chronic phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must not have previously experienced a failure to respond to PBS-subsidised first-line treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first-line therapy for this condition; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.<br/>Patients should be commenced on a dose of nilotinib of 300 mg twice daily. Continuing therapy is dependent on patients demonstrating a response to nilotinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.</p> <p align=""justify"">A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12566_12566_R","Consolidation treatment","AUTHORITY_REQUIRED","12566","12566","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Consolidation treatment</p><br/><p>Patient must have achieved a complete remission following induction treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with standard intensive remission consolidation chemotherapy for this condition, which must include cytarabine and an anthracycline; AND</p> <p>Patient must not receive more than 2 consolidation cycles under this restriction in a lifetime.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">Complete remission following induction is defined as fewer than 5% blasts in a normocellular marrow and an absolute neutrophil count of more than 1.0 x 10<sup>9</sup> cells/L with a platelet count of 100 x 10<sup>9</sup>/L or more in the peripheral blood in the absence of transfusion.</p> <p align=""justify"">Progressive disease is defined as the presence of any of the following:</p><p align=""justify"">a) Leukaemic cells in the CSF;</p><p align=""justify"">b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;</p><p align=""justify"">c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;</p><p align=""justify"">d) Extramedullary leukaemia.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Consolidation treatment</p><br/><p>Patient must have achieved a complete remission following induction treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with standard intensive remission consolidation chemotherapy for this condition, which must include cytarabine and an anthracycline; AND</p> <p>Patient must not receive more than 2 consolidation cycles under this restriction in a lifetime.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">Complete remission following induction is defined as fewer than 5% blasts in a normocellular marrow and an absolute neutrophil count of more than 1.0 x 10<sup>9</sup> cells/L with a platelet count of 100 x 10<sup>9</sup>/L or more in the peripheral blood in the absence of transfusion.</p> <p align=""justify"">Progressive disease is defined as the presence of any of the following:</p><p align=""justify"">a) Leukaemic cells in the CSF;</p><p align=""justify"">b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;</p><p align=""justify"">c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;</p><p align=""justify"">d) Extramedullary leukaemia.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12567_12567_R","Continuing treatment","STREAMLINED","12567","12567","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic graft versus host disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received, at anytime prior to this pharmaceutical benefit within the same treatment episode, both: (i) this drug subsidised through the Initial treatment listing, (ii) the extracorporeal photopheresis-MBS benefit for initial treatment; AND</p> <p>Patient must have demonstrated a response to initial treatment with this drug (administered as part of MBS-subsidised extracorporeal photopheresis treatment) obtained through this drug''s ''Initial treatment'' PBS-listing for the same treatment episode; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition; AND</p> <p>Patient must not be undergoing re-treatment through this treatment phase immediately following a relapse - see ''Initial treatment'' for resuming treatment following relapse.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic graft versus host disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received, at anytime prior to this pharmaceutical benefit within the same treatment episode, both: (i) this drug subsidised through the Initial treatment listing, (ii) the extracorporeal photopheresis-MBS benefit for initial treatment; AND</p> <p>Patient must have demonstrated a response to initial treatment with this drug (administered as part of MBS-subsidised extracorporeal photopheresis treatment) obtained through this drug''s ''Initial treatment'' PBS-listing for the same treatment episode; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition; AND</p> <p>Patient must not be undergoing re-treatment through this treatment phase immediately following a relapse - see ''Initial treatment'' for resuming treatment following relapse.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12579_12579_R","Initial treatment in a treatment episode","STREAMLINED","12579","12579","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic graft versus host disease</p><br/><p>Initial treatment in a treatment episode</p><br/><p>The condition must be inadequately responsive to systemic corticosteroid treatment at a therapeutic dose, but has never been treated with this drug; or</p> <p>The condition must have relapsed within 8 weeks of prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis; or</p> <p>The condition must have relapsed with each of the following conditions being met: (i) prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis last occurred at least 8 weeks ago, (ii) a subsequent trial of systemic corticosteroids at therapeutic doses has been completed; AND</p> <p>Patient must be undergoing treatment with this drug that is being administered within at least one of: (i) the first 12 weeks of a treatment episode, (ii) the first 25 doses (inclusive of the 25th dose) of a treatment episode; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation; AND</p> <p>Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic graft versus host disease</p><br/><p>Initial treatment in a treatment episode</p><br/><p>The condition must be inadequately responsive to systemic corticosteroid treatment at a therapeutic dose, but has never been treated with this drug; or</p> <p>The condition must have relapsed within 8 weeks of prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis; or</p> <p>The condition must have relapsed with each of the following conditions being met: (i) prior PBS-subsidised treatment with this drug administered via extracorporeal photopheresis last occurred at least 8 weeks ago, (ii) a subsequent trial of systemic corticosteroids at therapeutic doses has been completed; AND</p> <p>Patient must be undergoing treatment with this drug that is being administered within at least one of: (i) the first 12 weeks of a treatment episode, (ii) the first 25 doses (inclusive of the 25th dose) of a treatment episode; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation; AND</p> <p>Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2022-03-01","N","4708"
"12585_12585_R","Initial treatment","AUTHORITY_REQUIRED","12585","12585","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic multicentric Castleman disease (iMCD)</p><br/><p>Initial treatment</p><br/><p>Patient must have a diagnosis of iMCD consistent with the latest international, evidence-based consensus diagnostic criteria for this condition with the relevant diagnostic findings documented in the patient''s medical records; AND</p> <p>The condition must not be, to the prescriber''s best knowledge, any of the following diseases that can mimic iMCD: (i) human herpes virus-8 infection, (ii) an Epstein-Barr virus-lymphoproliferative disorder, (iii) an acute/uncontrolled infection (e.g. cytomegalovirus, toxoplasmosis, human immunodeficiency virus, tuberculosis) leading to inflammation with adenopathy, (iv) an autoimmune/autoinflammatory disease, (v) a malignant/lymphoproliferative disorder; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist; AND</p> <p>Patient must be undergoing treatment through this treatment phase once only in a lifetime, where the full number of repeats are prescribed; or</p> <p>Patient must be undergoing treatment through this treatment phase for up to the first 5 doses in a lifetime, where the full number of repeats was not prescribed with the first prescription.</p> <p align=""justify"">Prescribe the most efficient combination of vials/strengths based on the patient&apos;s body weight to keep any amount of unused drug to a minimum.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic multicentric Castleman disease (iMCD)</p><br/><p>Initial treatment</p><br/><p>Patient must have a diagnosis of iMCD consistent with the latest international, evidence-based consensus diagnostic criteria for this condition with the relevant diagnostic findings documented in the patient''s medical records; AND</p> <p>The condition must not be, to the prescriber''s best knowledge, any of the following diseases that can mimic iMCD: (i) human herpes virus-8 infection, (ii) an Epstein-Barr virus-lymphoproliferative disorder, (iii) an acute/uncontrolled infection (e.g. cytomegalovirus, toxoplasmosis, human immunodeficiency virus, tuberculosis) leading to inflammation with adenopathy, (iv) an autoimmune/autoinflammatory disease, (v) a malignant/lymphoproliferative disorder; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist; AND</p> <p>Patient must be undergoing treatment through this treatment phase once only in a lifetime, where the full number of repeats are prescribed; or</p> <p>Patient must be undergoing treatment through this treatment phase for up to the first 5 doses in a lifetime, where the full number of repeats was not prescribed with the first prescription.</p> <p align=""justify"">Prescribe the most efficient combination of vials/strengths based on the patient&apos;s body weight to keep any amount of unused drug to a minimum.</p> <p align=""justify"">The international, evidence-based consensus iMCD diagnostic criteria developed by an international working group of clinical experts lists various findings under &apos;Major&apos; and &apos;Minor&apos; diagnostic criteria that constitute a diagnosis of iMCD. At the time of writing, under these consensus criteria, diagnostic findings that meet: (i) both Major criteria and (ii) at least 2 of 11 Minor criteria including at least 1 laboratory abnormality and (iii) exclude various differential diagnoses, form a diagnosis of iMCD.</p><p align=""justify"">Details of these criteria are presented in Table 2 of the following literature article:</p><p align=""justify"">Fajgenbaum DC, Uldrick TS, Bagg A, Frank D et. al. International, evidence-based consensus diagnostic criteria for HHV-8-negative/idiopathic multicentric Castleman disease. <i>Blood</i> 2017; 129(12): 1646-1657.</p><p align=""justify"">Where updates to these diagnostic criteria have occurred since the publication, refer to the latest version.</p><p align=""justify"">Do not contact the PBS-administrator to discuss whether an individual patient meets these consensus criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2022-04-01","N","4708"
"12586_12603_R","null","STREAMLINED","12603","12586","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.</p>","N","N","N","IMMEDIATE","ALL","N","2022-04-01","N","4708"
"12590_12590_R","Initial treatment","AUTHORITY_REQUIRED","12590","12590","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>Initial treatment</p><br/><p>The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND</p> <p>The treatment must not be subsidised in combination with: (i) chemotherapy, (ii) a novel hormonal drug; AND</p> <p>The condition must have progressed following prior treatment that included a novel hormonal drug for this condition (metastatic/non-metastatic disease); AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must be undergoing treatment with this drug for the first time.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>Initial treatment</p><br/><p>The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND</p> <p>The treatment must not be subsidised in combination with: (i) chemotherapy, (ii) a novel hormonal drug; AND</p> <p>The condition must have progressed following prior treatment that included a novel hormonal drug for this condition (metastatic/non-metastatic disease); AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must be undergoing treatment with this drug for the first time.</p>","N","N","N","IMMEDIATE","ALL","N","2022-04-01","N","4708"
"12594_12594_R","Continuing treatment","AUTHORITY_REQUIRED","12594","12594","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic multicentric Castleman disease (iMCD)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist.</p> <p align=""justify"">Prescribe the most efficient combination of vials/strengths based on the patient&apos;s body weight to keep any amount of unused drug to a minimum.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic multicentric Castleman disease (iMCD)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a medical physician working under the supervision of a haematologist.</p> <p align=""justify"">Prescribe the most efficient combination of vials/strengths based on the patient&apos;s body weight to keep any amount of unused drug to a minimum.</p>","N","N","N","IMMEDIATE","ALL","N","2022-04-01","N","4708"
"12595_12599_R","null","RESTRICTED","12599","12595","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND</p> <p>The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND</p> <p>The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.</p> <p align=""justify"">Formal assessment and correction of inhaler technique should be performed in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique (available at www.humanservices.gov.au or www.nationalasthma.org.au); the assessment and adherence to correct technique should be documented in the patient&apos;s medical records. Patients can obtain support with inhaler technique through their local Asthma Foundation (1800 645 130).</p>","N","N","N","IMMEDIATE","ALL","N","2022-04-01","N","4708"
"12602_12604_R","null","STREAMLINED","12604","12602","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human sarcoptic scabies</p><br/><p>The condition must be established by clinical and/or parasitological examination; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Patient must weigh 15 kg or over; AND</p> <p>Patient must be 5 years of age or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human sarcoptic scabies</p><br/><p>The condition must be established by clinical and/or parasitological examination; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Patient must weigh 15 kg or over; AND</p> <p>Patient must be 5 years of age or older.</p>","N","N","N","IMMEDIATE","ALL","N","2022-04-01","N","4708"
"12608_12462_R","null","AUTHORITY_REQUIRED","12462","12608","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>The condition must be previously untreated at the time of initiation with this drug (except for essential treatment with hydroxyurea or leukapheresis); AND</p> <p>Patient must not be considered eligible for standard intensive remission induction chemotherapy at the time of initiation with this drug; AND</p> <p>The treatment must be used in combination with azacitidine (refer to Product Information for timing of azacitidine and venetoclax doses); AND</p> <p>Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must not be acute promyelocytic leukaemia.</p> <p align=""justify"">Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.</p><p align=""justify"">If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>The condition must be previously untreated at the time of initiation with this drug (except for essential treatment with hydroxyurea or leukapheresis); AND</p> <p>Patient must not be considered eligible for standard intensive remission induction chemotherapy at the time of initiation with this drug; AND</p> <p>The treatment must be used in combination with azacitidine (refer to Product Information for timing of azacitidine and venetoclax doses); AND</p> <p>Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must not be acute promyelocytic leukaemia.</p> <p align=""justify"">Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.</p><p align=""justify"">If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","N","IMMEDIATE","ALL","N","2022-04-01","N","4708"
"12619_12619_R","null","STREAMLINED","12619","12619","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Patient must be virologically suppressed on a stable antiretroviral regimen for at least 6 months; AND</p> <p>The treatment must be in combination with rilpivirine tablets; AND</p> <p>Patient must intend to proceed to treatment with intramuscular administration of cabotegravir and rilpivirine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Patient must be virologically suppressed on a stable antiretroviral regimen for at least 6 months; AND</p> <p>The treatment must be in combination with rilpivirine tablets; AND</p> <p>Patient must intend to proceed to treatment with intramuscular administration of cabotegravir and rilpivirine.</p>","N","N","N","IMMEDIATE","ALL","N","2022-04-01","N","4708"
"12636_12636_R","null","STREAMLINED","12636","12636","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Patient must have previously received PBS-subsidised therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Patient must have previously received PBS-subsidised therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2022-04-01","N","4708"
"12656_12656_R","Initial treatment","STREAMLINED","12656","12656","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable locally advanced or metastatic triple-negative breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have progressive disease following two or more prior systemic therapies, at least one of them in the locally advanced or metastatic setting; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this PBS indication.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable locally advanced or metastatic triple-negative breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have progressive disease following two or more prior systemic therapies, at least one of them in the locally advanced or metastatic setting; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this PBS indication.</p>","N","N","N","IMMEDIATE","ALL","N","2022-05-01","N","4708"
"12657_12669_R","Continuing treatment","STREAMLINED","12669","12657","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable locally advanced or metastatic triple-negative breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this PBS indication.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable locally advanced or metastatic triple-negative breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this PBS indication.</p>","N","N","N","IMMEDIATE","ALL","N","2022-05-01","N","4708"
"12663_12685_R","Initial treatment","AUTHORITY_REQUIRED","12685","12663","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Malignant gastrointestinal stromal tumour</p><br/><p>Initial treatment</p><br/><p>The condition must be metastatic; or</p> <p>The condition must be unresectable; AND</p> <p>The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND</p> <p>The condition must have not achieved a response with this drug at a dose of 400 mg per day; AND</p> <p>The treatment must not exceed 3 months under this restriction.</p> <p>Authority prescriptions for a higher dose will not be approved during this initial 3 month treatment period.</p> <p align=""justify"">Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.</p><p align=""justify"">A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.)</p> <p align=""justify"">A pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Details of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour(s), including whether or not there is evidence of metastatic disease must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Malignant gastrointestinal stromal tumour</p><br/><p>Initial treatment</p><br/><p>The condition must be metastatic; or</p> <p>The condition must be unresectable; AND</p> <p>The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND</p> <p>The condition must have not achieved a response with this drug at a dose of 400 mg per day; AND</p> <p>The treatment must not exceed 3 months under this restriction.</p> <p>Authority prescriptions for a higher dose will not be approved during this initial 3 month treatment period.</p> <p align=""justify"">Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.</p><p align=""justify"">A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.)</p> <p align=""justify"">A pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Details of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour(s), including whether or not there is evidence of metastatic disease must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2022-05-01","N","4708"
"12664_4660_R","null","RESTRICTED","4660","12664","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a source of medium chain triglycerides</p><br/><p>Patient must have fat malabsorption due to liver disease; or</p> <p>Patient must have fat malabsorption due to short gut syndrome; or</p> <p>Patient must have fat malabsorption due to cystic fibrosis; or</p> <p>Patient must have fat malabsorption due to gastrointestinal disorders.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a source of medium chain triglycerides</p><br/><p>Patient must have fat malabsorption due to liver disease; or</p> <p>Patient must have fat malabsorption due to short gut syndrome; or</p> <p>Patient must have fat malabsorption due to cystic fibrosis; or</p> <p>Patient must have fat malabsorption due to gastrointestinal disorders.</p>","N","N","N","IMMEDIATE","ALL","N","2022-05-01","N","4708"
"12695_12694_R","Initial treatment - once weekly treatment regimen","STREAMLINED","12694","12695","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment - once weekly treatment regimen</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must be in combination with dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must have undergone or be ineligible for a stem cell transplant; AND</p> <p>Patient must not have previously received this drug for this condition; AND</p> <p>Patient must not receive more than three cycles of treatment under this restriction.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment - once weekly treatment regimen</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must be in combination with dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must have undergone or be ineligible for a stem cell transplant; AND</p> <p>Patient must not have previously received this drug for this condition; AND</p> <p>Patient must not receive more than three cycles of treatment under this restriction.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2022-05-01","N","4708"
"12696_12849_R","Continuing treatment - once weekly treatment regimen","STREAMLINED","12849","12696","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment - once weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with dexamethasone; AND</p> <p>Patient must not develop disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment - once weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with dexamethasone; AND</p> <p>Patient must not develop disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2022-05-01","N","4708"
"12697_12930_R","Continuing treatment - twice weekly treatment regimen","STREAMLINED","12930","12697","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment - twice weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with dexamethasone; AND</p> <p>Patient must not develop disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment - twice weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with dexamethasone; AND</p> <p>Patient must not develop disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2022-05-01","N","4708"
"12819_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms desvenlafaxine tablet (modified release) 50 mg, desvenlafaxine tablet (modified release) 50 mg (as benzoate) and desvenlafaxine tablet (extended release) 50 mg (as succinate) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-04-01","N","4708"
"12820_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms desvenlafaxine tablet (modified release) 100 mg, desvenlafaxine tablet (modified release) 100 mg (as benzoate) and desvenlafaxine tablet (extended release) 100 mg (as succinate) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-04-01","N","4708"
"12910_12934_R","Initial treatment - twice weekly treatment regimen","STREAMLINED","12934","12910","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment - twice weekly treatment regimen</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must be in combination with dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must have undergone or be ineligible for a stem cell transplant; AND</p> <p>Patient must not have previously received this drug for this condition; AND</p> <p>Patient must not receive more than three cycles of treatment under this restriction.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment - twice weekly treatment regimen</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must be in combination with dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must have undergone or be ineligible for a stem cell transplant; AND</p> <p>Patient must not have previously received this drug for this condition; AND</p> <p>Patient must not receive more than three cycles of treatment under this restriction.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2022-05-01","N","4708"
"12911_12691_R","Continuing treatment of second-line drug therapy from week 25 until disease progression (administered every 4 weeks)","AUTHORITY_REQUIRED","12691","12911","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment of second-line drug therapy from week 25 until disease progression (administered every 4 weeks)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment of second-line drug therapy from week 25 until disease progression (administered every 4 weeks)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2022-05-01","N","4708"
"12912_12845_R","Continuing treatment of second-line drug therapy for weeks 10 to 24 (administered every 3 weeks)","AUTHORITY_REQUIRED","12845","12912","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment of second-line drug therapy for weeks 10 to 24 (administered every 3 weeks)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with bortezomib and dexamethasone; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment of second-line drug therapy for weeks 10 to 24 (administered every 3 weeks)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with bortezomib and dexamethasone; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2022-05-01","N","4708"
"12912_N","null","null","null","null","null","<p align=""justify"">This medicine is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.</p>","Y","N","N","null","null","N","2016-04-01","N","4708"
"12913_12847_R","Continuing treatment","AUTHORITY_REQUIRED","12847","12913","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with lenalidomide and dexamethasone; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with lenalidomide and dexamethasone; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","N","IMMEDIATE","ALL","N","2022-05-01","N","4708"
"12940_4998_R","Continuing treatment","STREAMLINED","4998","12940","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a psychiatrist; or</p> <p>Must be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; AND</p> <p>Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND</p> <p>Patient must have completed at least 18 weeks therapy; AND</p> <p>Patient must be on a clozapine dosage considered stable by a treating psychiatrist; AND</p> <p>The treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.</p> <p align=""justify"">A medical practitioner should request a quantity sufficient for up to one month&apos;s supply. Up to 5 repeats will be authorised. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a psychiatrist; or</p> <p>Must be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; AND</p> <p>Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND</p> <p>Patient must have completed at least 18 weeks therapy; AND</p> <p>Patient must be on a clozapine dosage considered stable by a treating psychiatrist; AND</p> <p>The treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.</p> <p align=""justify"">A medical practitioner should request a quantity sufficient for up to one month&apos;s supply. Up to 5 repeats will be authorised. </p>","N","N","N","IMMEDIATE","ALL","N","2022-06-01","N","4708"
"12941_11390_R","Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","11390","12941","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patients) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patients) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-06-01","N","4708"
"12951_5015_R","Initial treatment","STREAMLINED","5015","12951","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Initial treatment</p><br/><p>Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient; AND</p> <p>Patient must be non-responsive to other neuroleptic agents; or</p> <p>Patient must be intolerant of other neuroleptic agents.</p> <p align=""justify"">Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.</p> <p>The name of the consulting psychiatrist should be included in the patient&apos;s medical records.</p> <p align=""justify"">A medical practitioner should request a quantity sufficient for up to one month&apos;s supply. Up to 5 repeats will be authorised. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Initial treatment</p><br/><p>Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient; AND</p> <p>Patient must be non-responsive to other neuroleptic agents; or</p> <p>Patient must be intolerant of other neuroleptic agents.</p> <p align=""justify"">Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.</p> <p>The name of the consulting psychiatrist should be included in the patient&apos;s medical records.</p> <p align=""justify"">A medical practitioner should request a quantity sufficient for up to one month&apos;s supply. Up to 5 repeats will be authorised. </p>","N","N","N","IMMEDIATE","ALL","N","2022-06-01","N","4708"
"12952_9490_R","Initial treatment","STREAMLINED","9490","12952","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Initial treatment</p><br/><p>Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient; AND</p> <p>Patient must be non-responsive to other neuroleptic agents; or</p> <p>Patient must be intolerant of other neuroleptic agents.</p> <p align=""justify"">Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.</p> <p>The name of the consulting psychiatrist should be included in the patient&apos;s medical records.</p> <p align=""justify"">A medical practitioner should request a quantity sufficient for up to one month&apos;s supply. Up to 5 repeats will be authorised. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Initial treatment</p><br/><p>Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient; AND</p> <p>Patient must be non-responsive to other neuroleptic agents; or</p> <p>Patient must be intolerant of other neuroleptic agents.</p> <p align=""justify"">Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.</p> <p>The name of the consulting psychiatrist should be included in the patient&apos;s medical records.</p> <p align=""justify"">A medical practitioner should request a quantity sufficient for up to one month&apos;s supply. Up to 5 repeats will be authorised. </p>","N","N","N","IMMEDIATE","ALL","N","2022-06-01","N","4708"
"12974_12392_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","12392","12974","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-06-01","N","4708"
"12975_5754_R","Continuing treatment","RESTRICTED","5754","12975","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Venous ulcer</p><br/><p>Continuing treatment</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Venous ulcer</p><br/><p>Continuing treatment</p>","N","N","N","IMMEDIATE","ALL","N","2022-07-01","N","4708"
"12977_5620_R","Initial treatment","RESTRICTED","5620","12977","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Venous ulcer</p><br/><p>Initial treatment</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Venous ulcer</p><br/><p>Initial treatment</p>","N","N","N","IMMEDIATE","ALL","N","2022-07-01","N","4708"
"12978_12976_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","12976","12978","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p> <p align=""justify"">If a dose increase from tofacitinib 5mg twice daily to tofacitinib 10mg twice daily is required, tofacitinib 10mg may be authorised under this restriction to complete up to 24 weeks continuing treatment.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-07-01","N","4708"
"12979_12979_R","null","AUTHORITY_REQUIRED","12979","12979","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Lambert-Eaton myasthenic syndrome (LEMS)</p><br/><p>The condition must not be any of: (i) myasthenia gravis, (ii) Guillain-Barre syndrome; AND</p> <p>Must be treated by a prescriber type identifying as at least one of the following: (i) a clinical immunologist, (ii) a neurologist, (iii) a medical practitioner working under the direct supervision of one of these mentioned specialists.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Lambert-Eaton myasthenic syndrome (LEMS)</p><br/><p>The condition must not be any of: (i) myasthenia gravis, (ii) Guillain-Barre syndrome; AND</p> <p>Must be treated by a prescriber type identifying as at least one of the following: (i) a clinical immunologist, (ii) a neurologist, (iii) a medical practitioner working under the direct supervision of one of these mentioned specialists.</p>","N","N","N","IMMEDIATE","ALL","N","2022-07-01","N","4708"
"12984_13011_R","Continuing treatment","AUTHORITY_REQUIRED","13011","12984","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p> <p align=""justify"">Up to 6 cycles will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p> <p align=""justify"">Up to 6 cycles will be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2022-07-01","N","4708"
"12986_12986_R","Continuing treatment","STREAMLINED","12986","12986","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p> <p align=""justify"">Authority applications for increased quantities/repeats (where relevant) may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-07-01","N","4708"
"12987_13029_R","Initial treatment","AUTHORITY_REQUIRED","13029","12987","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myelomonocytic Leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; AND</p> <p>The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder.</p> <p align=""justify"">The first authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and</p><p align=""justify"">(b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology Authority</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and</p><p align=""justify"">(b) full blood examination report</p> <p align=""justify"">No more than 3 cycles will be authorised under this restriction in a patient&apos;s lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myelomonocytic Leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; AND</p> <p>The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder.</p> <p align=""justify"">The first authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and</p><p align=""justify"">(b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology Authority</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and</p><p align=""justify"">(b) full blood examination report</p> <p align=""justify"">No more than 3 cycles will be authorised under this restriction in a patient&apos;s lifetime.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2022-07-01","Y","4708"
"12988_13015_R","Continuing treatment","AUTHORITY_REQUIRED","13015","12988","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myelomonocytic Leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p> <p align=""justify"">Up to 6 cycles will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myelomonocytic Leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p> <p align=""justify"">Up to 6 cycles will be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2022-07-01","N","4708"
"12994_13012_R","Continuing treatment","STREAMLINED","13012","12994","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p> <p align=""justify"">Authority applications for increased quantities/repeats (where relevant) may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-07-01","N","4708"
"12998_13018_R","Initial treatment","AUTHORITY_REQUIRED","13018","12998","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must not have received prior anti-HER2 therapy for this condition; AND</p> <p>Patient must not have received prior chemotherapy for this condition; AND</p> <p>The treatment must be in combination with trastuzumab and a taxane; AND</p> <p>The treatment must not be in combination with nab-paclitaxel; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">Details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) must be provided at the time of application.</p><p align=""justify"">The pathology report must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must not have received prior anti-HER2 therapy for this condition; AND</p> <p>Patient must not have received prior chemotherapy for this condition; AND</p> <p>The treatment must be in combination with trastuzumab and a taxane; AND</p> <p>The treatment must not be in combination with nab-paclitaxel; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">Details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) must be provided at the time of application.</p><p align=""justify"">The pathology report must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-07-01","N","4708"
"13000_13010_R","Initial treatment","AUTHORITY_REQUIRED","13010","13000","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be acute myeloid leukaemia confirmed through a bone marrow biopsy report and full blood examination; AND</p> <p>The condition must have 20% to 30% marrow blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) bone marrow biopsy report demonstrating that the patient has acute myeloid leukaemia; and</p><p align=""justify"">(b) full blood examination report.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be acute myeloid leukaemia confirmed through a bone marrow biopsy report and full blood examination; AND</p> <p>The condition must have 20% to 30% marrow blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) bone marrow biopsy report demonstrating that the patient has acute myeloid leukaemia; and</p><p align=""justify"">(b) full blood examination report.</p>","N","N","N","IMMEDIATE","ALL","N","2022-07-01","N","4708"
"13014_13001_R","Induction / Consolidation therapy","AUTHORITY_REQUIRED","13001","13014","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Induction / Consolidation therapy</p><br/><p>Patient must not have received prior chemotherapy as induction therapy for this condition; or</p> <p>The treatment must be for consolidation treatment following induction treatment with midostaurin in combination with chemotherapy and the patient must not have progressive disease; AND</p> <p>The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>The condition must not be acute promyelocytic leukaemia; AND</p> <p>The treatment must be in combination with standard intensive remission induction or consolidation chemotherapy for this condition.</p> <p align=""justify"">A maximum of 6 cycles will be authorised under this restriction in a lifetime.</p> <p align=""justify"">Standard intensive remission induction combination chemotherapy must include cytarabine and an anthracycline.</p> <p align=""justify"">The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient&apos;s file.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.</p><p align=""justify"">If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.</p><p align=""justify"">Progressive disease is defined as the presence of any of the following:</p><ul><li>Leukaemic cells in the CSF;</li><li>Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;</li><li>Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;</li><li>Extramedullary leukaemia.</li></ul> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Induction / Consolidation therapy</p><br/><p>Patient must not have received prior chemotherapy as induction therapy for this condition; or</p> <p>The treatment must be for consolidation treatment following induction treatment with midostaurin in combination with chemotherapy and the patient must not have progressive disease; AND</p> <p>The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>The condition must not be acute promyelocytic leukaemia; AND</p> <p>The treatment must be in combination with standard intensive remission induction or consolidation chemotherapy for this condition.</p> <p align=""justify"">A maximum of 6 cycles will be authorised under this restriction in a lifetime.</p> <p align=""justify"">Standard intensive remission induction combination chemotherapy must include cytarabine and an anthracycline.</p> <p align=""justify"">The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient&apos;s file.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.</p><p align=""justify"">If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.</p><p align=""justify"">Progressive disease is defined as the presence of any of the following:</p><ul><li>Leukaemic cells in the CSF;</li><li>Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;</li><li>Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;</li><li>Extramedullary leukaemia.</li></ul> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>","N","N","N","IMMEDIATE","ALL","N","2022-07-01","N","4708"
"13016_10414_R","Continuing treatment","AUTHORITY_REQUIRED","10414","13016","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND</p> <p>The treatment must be in combination with trastuzumab; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.</p><p align=""justify"">The treatment must not exceed a lifetime total of one course. However, treatment breaks are permitted. A patient who has a treatment break in PBS-subsidised treatment with this drug for reasons other than disease progression is eligible to continue to receive PBS-subsidised treatment with this drug.</p><p align=""justify"">Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND</p> <p>The treatment must be in combination with trastuzumab; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.</p><p align=""justify"">The treatment must not exceed a lifetime total of one course. However, treatment breaks are permitted. A patient who has a treatment break in PBS-subsidised treatment with this drug for reasons other than disease progression is eligible to continue to receive PBS-subsidised treatment with this drug.</p><p align=""justify"">Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p> <p align=""justify"">The criterion that limits breaks in treatment with pertuzumab under this restriction has been temporarily modified due to the current risk of COVID-19. This allows an extended break in therapy with PBS-subsidised pertuzumab in patients who are at risk of COVID-19.</p>","N","N","Y","IMMEDIATE","ALL","N","2022-07-01","N","4708"
"13021_13013_R","Maintenance therapy - Initial treatment","AUTHORITY_REQUIRED","13013","13021","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Maintenance therapy - Initial treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated complete remission after induction and consolidation chemotherapy in combination with midostaurin confirmed through a bone marrow biopsy pathology report; AND</p> <p>Patient must not be undergoing or have undergone a stem cell transplant; AND</p> <p>The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority.</p> <p align=""justify"">A maximum of 3 cycles will be authorised under this restriction in a lifetime.</p> <p align=""justify"">Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.</p><p align=""justify"">If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.</p><p align=""justify"">Progressive disease is defined as the presence of any of the following:</p><ul><li>Leukaemic cells in the CSF;</li><li>Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;</li><li>Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;</li><li>Extramedullary leukaemia.</li></ul> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) confirmation that the patient is not undergoing or has not undergone a stem cell transplant; and</p><p align=""justify"">(b) confirmation that the patient does not have progressive disease; and</p><p align=""justify"">(c) details (date, unique identifying number/code or provider number) of a recent bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient is in complete remission; and</p><p align=""justify"">(d) details (date, unique identifying number/code or provider number) of the pathology test demonstrating that the condition was FMS tyrosine kinase 3 (FLT3) (ITD or TKD) mutation positive prior to commencing midostaurin.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS upload or mail, it must include:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Maintenance therapy - Initial treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated complete remission after induction and consolidation chemotherapy in combination with midostaurin confirmed through a bone marrow biopsy pathology report; AND</p> <p>Patient must not be undergoing or have undergone a stem cell transplant; AND</p> <p>The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority.</p> <p align=""justify"">A maximum of 3 cycles will be authorised under this restriction in a lifetime.</p> <p align=""justify"">Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.</p><p align=""justify"">If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.</p><p align=""justify"">Progressive disease is defined as the presence of any of the following:</p><ul><li>Leukaemic cells in the CSF;</li><li>Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;</li><li>Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;</li><li>Extramedullary leukaemia.</li></ul> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) confirmation that the patient is not undergoing or has not undergone a stem cell transplant; and</p><p align=""justify"">(b) confirmation that the patient does not have progressive disease; and</p><p align=""justify"">(c) details (date, unique identifying number/code or provider number) of a recent bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient is in complete remission; and</p><p align=""justify"">(d) details (date, unique identifying number/code or provider number) of the pathology test demonstrating that the condition was FMS tyrosine kinase 3 (FLT3) (ITD or TKD) mutation positive prior to commencing midostaurin.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS upload or mail, it must include:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2022-07-01","Y","4708"
"13023_12983_R","Initial treatment","AUTHORITY_REQUIRED","12983","13023","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic syndrome</p><br/><p>Initial treatment</p><br/><p>The condition must be myelodysplastic syndrome confirmed through a bone marrow biopsy report and full blood examination; AND</p> <p>The condition must be classified as Intermediate-2 according to the International Prognostic Scoring System (IPSS); or</p> <p>The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS).</p> <p align=""justify"">Classification of the condition as Intermediate-2 requires a score of 1.5 to 2.0 on the IPSS, achieved with the possible combinations:</p><p align=""justify"">a. 11% to 30% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 0 to 1 cytopenias; OR</p><p align=""justify"">b. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR</p><p align=""justify"">c. 11% to 20% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR</p><p align=""justify"">d. 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR</p><p align=""justify"">e. 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR</p><p align=""justify"">f. Less than 5% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), and 2 to 3 cytopenias.</p> <p align=""justify"">Classification of the condition as high risk requires a score of 2.5 or more on the IPSS, achieved with the possible combinations:</p><p align=""justify"">a. 21% to 30% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR</p><p align=""justify"">b. 21% to 30% marrow blasts with intermediate (other abnormalities) or poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR</p><p align=""justify"">c. 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR</p><p align=""justify"">d. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application:</p><p align=""justify"">(a) The patient&apos;s International Prognostic Scoring System (IPSS) score</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and</p><p align=""justify"">(b) full blood examination report; and</p><p align=""justify"">(c) pathology report detailing the cytogenetics demonstrating intermediate-2 or high-risk disease according to the International Prognostic Scoring System (IPSS).</p> <p align=""justify"">No more than 3 cycles will be authorised under this restriction in a patient&apos;s lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic syndrome</p><br/><p>Initial treatment</p><br/><p>The condition must be myelodysplastic syndrome confirmed through a bone marrow biopsy report and full blood examination; AND</p> <p>The condition must be classified as Intermediate-2 according to the International Prognostic Scoring System (IPSS); or</p> <p>The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS).</p> <p align=""justify"">Classification of the condition as Intermediate-2 requires a score of 1.5 to 2.0 on the IPSS, achieved with the possible combinations:</p><p align=""justify"">a. 11% to 30% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 0 to 1 cytopenias; OR</p><p align=""justify"">b. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR</p><p align=""justify"">c. 11% to 20% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR</p><p align=""justify"">d. 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR</p><p align=""justify"">e. 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR</p><p align=""justify"">f. Less than 5% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), and 2 to 3 cytopenias.</p> <p align=""justify"">Classification of the condition as high risk requires a score of 2.5 or more on the IPSS, achieved with the possible combinations:</p><p align=""justify"">a. 21% to 30% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR</p><p align=""justify"">b. 21% to 30% marrow blasts with intermediate (other abnormalities) or poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR</p><p align=""justify"">c. 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR</p><p align=""justify"">d. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application:</p><p align=""justify"">(a) The patient&apos;s International Prognostic Scoring System (IPSS) score</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and</p><p align=""justify"">(b) full blood examination report; and</p><p align=""justify"">(c) pathology report detailing the cytogenetics demonstrating intermediate-2 or high-risk disease according to the International Prognostic Scoring System (IPSS).</p> <p align=""justify"">No more than 3 cycles will be authorised under this restriction in a patient&apos;s lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2022-07-01","N","4708"
"13041_13096_R","Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription","AUTHORITY_REQUIRED","13096","13041","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis; AND</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as &apos;Cancelled&apos;.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis; AND</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as &apos;Cancelled&apos;.</p>","N","N","N","IMMEDIATE","ALL","N","2022-08-01","N","4708"
"13042_13058_R","Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription","AUTHORITY_REQUIRED","13058","13042","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as &apos;Cancelled&apos;.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as &apos;Cancelled&apos;.</p>","N","N","N","IMMEDIATE","ALL","N","2022-08-01","N","4708"
"13044_13045_R","Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made","AUTHORITY_REQUIRED","13045","13044","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made</p><br/><p>Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND</p> <p>Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS administrator will confirm that:</p><p align=""justify"">(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;</p><p align=""justify"">(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made</p><br/><p>Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND</p> <p>Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS administrator will confirm that:</p><p align=""justify"">(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;</p><p align=""justify"">(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.</p>","N","N","N","FULL","ALL","N","2022-08-01","Y","4708"
"13050_13049_R","null","STREAMLINED","13049","13050","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months; or</p> <p>Patient must have previously received and be stabilised on PBS-subsidised paliperidone six-monthly injection for at least one cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months; or</p> <p>Patient must have previously received and be stabilised on PBS-subsidised paliperidone six-monthly injection for at least one cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2022-08-01","N","4708"
"13054_C","null","null","null","null","null","<p align=""justify"">In placebo controlled trials in elderly patients with dementia there was a significantly higher incidence of cerebrovascular adverse events, such as stroke (including fatalities) and transient ischaemic attacks, in patients treated with risperidone compared with patients treated with placebo.</p>","N","Y","N","null","null","N","2015-06-01","N","4708"
"13057_13077_R","Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made","AUTHORITY_REQUIRED","13077","13057","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made</p><br/><p>Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND</p> <p>Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS administrator will confirm that:</p><p align=""justify"">(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;</p><p align=""justify"">(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made</p><br/><p>Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND</p> <p>Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS administrator will confirm that:</p><p align=""justify"">(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;</p><p align=""justify"">(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.</p>","N","N","N","FULL","ALL","N","2022-08-01","Y","4708"
"13059_13040_R","Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription","AUTHORITY_REQUIRED","13040","13059","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as &apos;Cancelled&apos;.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as &apos;Cancelled&apos;.</p>","N","N","N","IMMEDIATE","ALL","N","2022-08-01","N","4708"
"13065_13082_R","null","STREAMLINED","13082","13065","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Patient must have previously received and be stabilised on PBS-subsidised paliperidone three-monthly injection for at least one cycle; or</p> <p>Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Patient must have previously received and be stabilised on PBS-subsidised paliperidone three-monthly injection for at least one cycle; or</p> <p>Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months.</p>","N","N","N","IMMEDIATE","ALL","N","2022-08-01","N","4708"
"13076_13039_R","Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made","AUTHORITY_REQUIRED","13039","13076","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made</p><br/><p>Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND</p> <p>Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS administrator will confirm that:</p><p align=""justify"">(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;</p><p align=""justify"">(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made</p><br/><p>Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND</p> <p>Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS administrator will confirm that:</p><p align=""justify"">(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;</p><p align=""justify"">(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.</p>","N","N","N","FULL","ALL","N","2022-08-01","Y","4708"
"13094_13094_R","Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription","AUTHORITY_REQUIRED","13094","13094","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as &apos;Cancelled&apos;.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true: (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as &apos;Cancelled&apos;.</p>","N","N","N","IMMEDIATE","ALL","N","2022-08-01","N","4708"
"13096_N","null","null","null","null","null","<p align=""justify"">Authorities for increased maximum quantities and/or repeats will not be granted except as detailed under the &apos;Authority required&apos; listing of temazepam. </p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"13099_N","null","null","null","null","null","<p align=""justify"">Care must be taken to comply with the provisions of State/Territory law when prescribing this drug.</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"13103_13097_R","Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made","AUTHORITY_REQUIRED","13097","13103","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made</p><br/><p>Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND</p> <p>Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS administrator will confirm that:</p><p align=""justify"">(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;</p><p align=""justify"">(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made</p><br/><p>Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND</p> <p>Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS administrator will confirm that:</p><p align=""justify"">(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;</p><p align=""justify"">(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.</p>","N","N","N","FULL","ALL","N","2022-08-01","Y","4708"
"13136_13261_R","Continuing treatment","AUTHORITY_REQUIRED","13261","13136","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>CD30 positive systemic anaplastic large cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed 12 cycles under this restriction in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>CD30 positive systemic anaplastic large cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed 12 cycles under this restriction in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2022-09-01","N","4708"
"13138_13212_R","Continuing treatment","AUTHORITY_REQUIRED","13212","13138","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>CD30 positive peripheral T-cell lymphoma, non-cutaneous type</p><br/><p>Continuing treatment</p><br/><p>The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND</p> <p>Patient must have completed 6 initial cycles of PBS-subsidised treatment with this drug for this indication; AND</p> <p>Patient must have achieved at least a partial response to the 6 initial cycles of treatment with a combination of this drug and cyclophosphamide, doxorubicin and prednisone for this indication; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.</p> <p align=""justify"">Partial response is defined using Lugano Response Criteria for Non-Hodgkin Lymphoma as:</p><p align=""justify"">(a) Positron emission tomography-based response: lymph nodes and extralymphatic sites - a score of 4 (uptake moderately &gt; liver), or 5 (uptake markedly higher than liver and/or new lesions), with reduced uptake compared with baseline and residual mass(es) of any size; nonmeasured lesions - not applicable; organ enlargement - not applicable; new lesions - none; bone marrow - residual uptake higher than uptake in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in the marrow in the context of a nodal response, consideration should be given to further evaluation with MRI or biopsy or an interval scan; OR</p><p align=""justify"">(b) Computed tomography-based response: lymph nodes and extralymphatic sites - greater than or equal to 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions, of up to six (6) target measurable nodes and extranodal sites; non-measured lesions - absent/normal, regressed but no increase; new lesions - none; bone marrow - not applicable.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>CD30 positive peripheral T-cell lymphoma, non-cutaneous type</p><br/><p>Continuing treatment</p><br/><p>The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND</p> <p>Patient must have completed 6 initial cycles of PBS-subsidised treatment with this drug for this indication; AND</p> <p>Patient must have achieved at least a partial response to the 6 initial cycles of treatment with a combination of this drug and cyclophosphamide, doxorubicin and prednisone for this indication; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.</p> <p align=""justify"">Partial response is defined using Lugano Response Criteria for Non-Hodgkin Lymphoma as:</p><p align=""justify"">(a) Positron emission tomography-based response: lymph nodes and extralymphatic sites - a score of 4 (uptake moderately &gt; liver), or 5 (uptake markedly higher than liver and/or new lesions), with reduced uptake compared with baseline and residual mass(es) of any size; nonmeasured lesions - not applicable; organ enlargement - not applicable; new lesions - none; bone marrow - residual uptake higher than uptake in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in the marrow in the context of a nodal response, consideration should be given to further evaluation with MRI or biopsy or an interval scan; OR</p><p align=""justify"">(b) Computed tomography-based response: lymph nodes and extralymphatic sites - greater than or equal to 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions, of up to six (6) target measurable nodes and extranodal sites; non-measured lesions - absent/normal, regressed but no increase; new lesions - none; bone marrow - not applicable.</p>","N","N","N","IMMEDIATE","ALL","N","2022-09-01","N","4708"
"13164_13257_R","Continuing treatment","AUTHORITY_REQUIRED","13257","13164","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p> <p align=""justify"">Up to 6 cycles will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p> <p align=""justify"">Up to 6 cycles will be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2022-10-01","N","4708"
"13180_13181_R","Continuing treatment","AUTHORITY_REQUIRED","13181","13180","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>CD30 positive cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved an objective response with this drug; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The treatment must not exceed 12 cycles under this restriction in a lifetime.</p> <p align=""justify"">An objective response is defined as the demonstration of response by clinical observation of skin lesions, or response by positron-emission tomography (PET) and/or computed tomography (CT) standard criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>CD30 positive cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved an objective response with this drug; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The treatment must not exceed 12 cycles under this restriction in a lifetime.</p> <p align=""justify"">An objective response is defined as the demonstration of response by clinical observation of skin lesions, or response by positron-emission tomography (PET) and/or computed tomography (CT) standard criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2022-09-01","N","4708"
"13185_13186_R","Continuing treatment","AUTHORITY_REQUIRED","13186","13185","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-09-01","N","4708"
"13200_13152_R","Initial treatment","AUTHORITY_REQUIRED","13152","13200","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable malignant gastrointestinal stromal tumour</p><br/><p>Initial treatment</p><br/><p>The condition must not be resectable; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have previously failed or be intolerant to imatinib mesilate.</p> <p align=""justify"">Applications for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) A completed authority prescription form; and</p><p align=""justify"">(b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable malignant gastrointestinal stromal tumour</p><br/><p>Initial treatment</p><br/><p>The condition must not be resectable; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have previously failed or be intolerant to imatinib mesilate.</p> <p align=""justify"">Applications for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) A completed authority prescription form; and</p><p align=""justify"">(b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","Y","FULL","ALL","N","2022-09-01","Y","4708"
"13203_N","null","null","null","null","null","<p align=""justify"">Aciclovir 200 mg is not PBS-subsidised for chickenpox, herpes zoster or herpes simplex infections other than genital herpes.</p>","Y","N","N","null","null","N","2015-05-01","N","4708"
"13206_13207_R","null","STREAMLINED","13207","13206","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>The treatment must be in combination with prednisone or prednisolone; AND</p> <p>The condition must be resistant to treatment with docetaxel; or</p> <p>Patient must have a documented intolerance necessitating permanent treatment withdrawal or a contraindication to docetaxel; AND</p> <p>The treatment must not be used in combination with a novel hormonal drug; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>The treatment must be in combination with prednisone or prednisolone; AND</p> <p>The condition must be resistant to treatment with docetaxel; or</p> <p>Patient must have a documented intolerance necessitating permanent treatment withdrawal or a contraindication to docetaxel; AND</p> <p>The treatment must not be used in combination with a novel hormonal drug; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel.</p>","N","N","N","IMMEDIATE","ALL","N","2022-09-01","N","4708"
"13210_7491_R","Initial treatment or Continuing treatment – balance of supply","AUTHORITY_REQUIRED","7491","13210","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced basal cell carcinoma (BCC)</p><br/><p>Initial treatment or Continuing treatment – balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete maximum of 16 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete maximum of 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced basal cell carcinoma (BCC)</p><br/><p>Initial treatment or Continuing treatment – balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete maximum of 16 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete maximum of 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-09-01","N","4708"
"13240_13165_R","Continuing treatment","AUTHORITY_REQUIRED","13165","13240","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myelomonocytic Leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p> <p align=""justify"">Up to 6 cycles will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myelomonocytic Leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p> <p align=""justify"">Up to 6 cycles will be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2022-10-01","N","4708"
"13241_13241_R","Initial treatment","AUTHORITY_REQUIRED","13241","13241","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be acute myeloid leukaemia confirmed through a bone marrow biopsy report and full blood examination; AND</p> <p>The condition must have 20% to 30% marrow blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) bone marrow biopsy report demonstrating that the patient has acute myeloid leukaemia; and</p><p align=""justify"">(b) full blood examination report.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be acute myeloid leukaemia confirmed through a bone marrow biopsy report and full blood examination; AND</p> <p>The condition must have 20% to 30% marrow blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) bone marrow biopsy report demonstrating that the patient has acute myeloid leukaemia; and</p><p align=""justify"">(b) full blood examination report.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 888 333.</p>","N","N","N","IMMEDIATE","ALL","N","2022-10-01","N","4708"
"13258_13258_R","Continuing treatment","STREAMLINED","13258","13258","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p>","N","N","N","IMMEDIATE","ALL","N","2022-10-01","N","4708"
"13262_13237_R","Balance of supply - subcutaneous form","AUTHORITY_REQUIRED","13237","13262","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Balance of supply - subcutaneous form</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); or</p> <p>Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment - subcutaneous form.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Balance of supply - subcutaneous form</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); or</p> <p>Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment - subcutaneous form.</p>","N","N","N","IMMEDIATE","ALL","N","2022-09-01","N","4708"
"13267_13267_R","Initial treatment","AUTHORITY_REQUIRED","13267","13267","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic syndrome</p><br/><p>Initial treatment</p><br/><p>The condition must be myelodysplastic syndrome confirmed through a bone marrow biopsy report and full blood examination; AND</p> <p>The condition must be classified as Intermediate-2 according to the International Prognostic Scoring System (IPSS); or</p> <p>The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS); AND</p> <p>The condition must have up to 20% marrow blasts according to World Health Organisation (WHO) Classification.</p> <p align=""justify"">Classification of the condition as Intermediate-2 requires a score of 1.5 to 2.0 on the IPSS, achieved with the possible combinations:</p><p align=""justify"">(a) 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR</p><p align=""justify"">(b) 11% to 20% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR</p><p align=""justify"">(c) 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR</p><p align=""justify"">(d) 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR</p><p align=""justify"">(e) Less than 5% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), and 2 to 3 cytopenias.</p> <p align=""justify"">Classification of the condition as high risk requires a score of 2.5 or more on the IPSS, achieved with the possible combinations:</p><p align=""justify"">(a) 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR</p><p align=""justify"">(b) 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application:</p><p align=""justify"">(a) The patient&apos;s International Prognostic Scoring System (IPSS) score.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and</p><p align=""justify"">(b) full blood examination report; and</p><p align=""justify"">(c) pathology report detailing the cytogenetics demonstrating intermediate-2 or high-risk disease according to the International Prognostic Scoring System (IPSS).</p> <p align=""justify"">No more than 3 cycles will be authorised under this restriction in a patient&apos;s lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic syndrome</p><br/><p>Initial treatment</p><br/><p>The condition must be myelodysplastic syndrome confirmed through a bone marrow biopsy report and full blood examination; AND</p> <p>The condition must be classified as Intermediate-2 according to the International Prognostic Scoring System (IPSS); or</p> <p>The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS); AND</p> <p>The condition must have up to 20% marrow blasts according to World Health Organisation (WHO) Classification.</p> <p align=""justify"">Classification of the condition as Intermediate-2 requires a score of 1.5 to 2.0 on the IPSS, achieved with the possible combinations:</p><p align=""justify"">(a) 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR</p><p align=""justify"">(b) 11% to 20% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR</p><p align=""justify"">(c) 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR</p><p align=""justify"">(d) 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR</p><p align=""justify"">(e) Less than 5% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), and 2 to 3 cytopenias.</p> <p align=""justify"">Classification of the condition as high risk requires a score of 2.5 or more on the IPSS, achieved with the possible combinations:</p><p align=""justify"">(a) 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR</p><p align=""justify"">(b) 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application:</p><p align=""justify"">(a) The patient&apos;s International Prognostic Scoring System (IPSS) score.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and</p><p align=""justify"">(b) full blood examination report; and</p><p align=""justify"">(c) pathology report detailing the cytogenetics demonstrating intermediate-2 or high-risk disease according to the International Prognostic Scoring System (IPSS).</p> <p align=""justify"">No more than 3 cycles will be authorised under this restriction in a patient&apos;s lifetime.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 888 333.</p>","N","N","N","IMMEDIATE","ALL","N","2022-10-01","N","4708"
"13287_N","null","null","null","null","null","<p align=""justify"">No applications for repeats will be authorised.</p>","Y","N","N","null","null","N","2015-05-01","N","4708"
"13290_13290_R","Maintenance therapy - Continuing treatment","STREAMLINED","13290","13290","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer</p><br/><p>Maintenance therapy - Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer</p><br/><p>Maintenance therapy - Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2022-10-01","N","4708"
"13290_N","null","null","null","null","null","<p align=""justify"">No applications for increased repeats will be authorised. </p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"13321_13321_R","null","AUTHORITY_REQUIRED","13321","13321","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chelation of elevated copper levels</p><br/><p>Patient must have a diagnosis of Wilson disease; AND</p> <p>Patient must be intolerant to penicillamine; AND</p> <p>Must be treated by a specialist medical practitioner, where this authority application is to initiate treatment with this drug, of the following type: (i) gastroenterologist, (ii) hepatologist, (iii) neurologist; the authority prescription must be completed by the specialist prescriber; or</p> <p>Must be treated by a medical practitioner (of any type), where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types; or</p> <p>Must be treated by a nurse practitioner where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types.</p> <p align=""justify"">Prior to seeking the initial authority approval, establish evidence of excess copper levels based on at least one of: (i) clinical symptoms, (ii) measured serum copper levels, (iii) measured urinary copper levels.</p><p align=""justify"">Document what these findings were in the patient&apos;s medical records. Do not supply them in this authority application.</p> <p align=""justify"">Refer to the following definitions if in doubt over what constitutes an acceptable intolerance to penicillamine:</p><p align=""justify"">Side effects of penicillamine occurring soon after initiation (within first few weeks/months):</p><p align=""justify"">(i) fever, (ii) rash, (iii) enlarged lymph nodes, (iv) neutropenia, (v) thrombocytopenia, (vi) proteinuria, (vii) severe, persistent nausea.</p><p align=""justify"">Side effects of penicillamine developing later:</p><p align=""justify"">(i) nephrotic syndrome, (ii) glomerulonephritis, (iii) total bone marrow aplasia, (iv) skin changes (cutis laxa, elastosis perforans serpiginosa, pemphigus), (v) myasthenia gravis, (vi) polymyositis, (vii) Goodpasture syndrome, (viii) optic neuritis, (ix) proteinuria (1-2 grams/day or equivalent in children, depending on specialist Wilson disease and renal review), (x) haematuria (if cause unknown), (xi) thrombocytopenia/leukopenia, (xii) bleeding related to thromobocytopenia/leukopenia, (xiii) lupus-like syndrome (haematuria, proteinuria, positive antinuclear antibody), (xiv) arthralgia.</p> <p align=""justify"">At the time of the first authority application for this drug, document the details (date of reaction, severity of reaction, dose of penicillamine, etc) of the penicillamine intolerance, if not already done, in the patient&apos;s medical records. Do not supply these details in this authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chelation of elevated copper levels</p><br/><p>Patient must have a diagnosis of Wilson disease; AND</p> <p>Patient must be intolerant to penicillamine; AND</p> <p>Must be treated by a specialist medical practitioner, where this authority application is to initiate treatment with this drug, of the following type: (i) gastroenterologist, (ii) hepatologist, (iii) neurologist; the authority prescription must be completed by the specialist prescriber; or</p> <p>Must be treated by a medical practitioner (of any type), where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types; or</p> <p>Must be treated by a nurse practitioner where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types.</p> <p align=""justify"">Prior to seeking the initial authority approval, establish evidence of excess copper levels based on at least one of: (i) clinical symptoms, (ii) measured serum copper levels, (iii) measured urinary copper levels.</p><p align=""justify"">Document what these findings were in the patient&apos;s medical records. Do not supply them in this authority application.</p> <p align=""justify"">Refer to the following definitions if in doubt over what constitutes an acceptable intolerance to penicillamine:</p><p align=""justify"">Side effects of penicillamine occurring soon after initiation (within first few weeks/months):</p><p align=""justify"">(i) fever, (ii) rash, (iii) enlarged lymph nodes, (iv) neutropenia, (v) thrombocytopenia, (vi) proteinuria, (vii) severe, persistent nausea.</p><p align=""justify"">Side effects of penicillamine developing later:</p><p align=""justify"">(i) nephrotic syndrome, (ii) glomerulonephritis, (iii) total bone marrow aplasia, (iv) skin changes (cutis laxa, elastosis perforans serpiginosa, pemphigus), (v) myasthenia gravis, (vi) polymyositis, (vii) Goodpasture syndrome, (viii) optic neuritis, (ix) proteinuria (1-2 grams/day or equivalent in children, depending on specialist Wilson disease and renal review), (x) haematuria (if cause unknown), (xi) thrombocytopenia/leukopenia, (xii) bleeding related to thromobocytopenia/leukopenia, (xiii) lupus-like syndrome (haematuria, proteinuria, positive antinuclear antibody), (xiv) arthralgia.</p> <p align=""justify"">At the time of the first authority application for this drug, document the details (date of reaction, severity of reaction, dose of penicillamine, etc) of the penicillamine intolerance, if not already done, in the patient&apos;s medical records. Do not supply these details in this authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2022-10-01","N","4708"
"13328_13396_R","Second or Subsequent Continuing treatment","AUTHORITY_REQUIRED","13396","13328","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Second or Subsequent Continuing treatment</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND</p> <p>Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.</p> <p align=""justify"">Authority approval will not be given for doses higher than 10 micrograms/kg/week</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Second or Subsequent Continuing treatment</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND</p> <p>Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.</p> <p align=""justify"">Authority approval will not be given for doses higher than 10 micrograms/kg/week</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-01-01","N","4708"
"13338_13387_R","Continuing treatment","STREAMLINED","13387","13338","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Branch retinal vein occlusion with macular oedema</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Branch retinal vein occlusion with macular oedema</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13339_13340_R","Continuing treatment","STREAMLINED","13340","13339","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must not be due to pathologic myopia; AND</p> <p>The condition must not be due to age-related macular degeneration; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must not be due to pathologic myopia; AND</p> <p>The condition must not be due to age-related macular degeneration; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13374_13327_R","Second or Subsequent Continuing treatment","AUTHORITY_REQUIRED","13327","13374","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Second or Subsequent Continuing treatment</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND</p> <p>Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Second or Subsequent Continuing treatment</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND</p> <p>Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-01-01","N","4708"
"13377_13377_R","Initial treatment - New patient","AUTHORITY_REQUIRED","13377","13377","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>X-linked hypophosphataemia</p><br/><p>Initial treatment - New patient</p><br/><p>Patient must have a documented confirmation of PHEX pathogenic variant; or</p> <p>Patient must have a confirmed diagnosis of X-linked hypophosphataemia demonstrated by the presence of all of the following: (i) a serum phosphate concentration below the age adjusted lower limit of normal; (ii) current or historical (for those with growth plate fusion) radiographic X-ray evidence of rickets; (iii) elevated (or inappropriately normal) serum or plasma FGF-23 levels of above the mean of the assay-specific reference range; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine; AND</p> <p>Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>X-linked hypophosphataemia</p><br/><p>Initial treatment - New patient</p><br/><p>Patient must have a documented confirmation of PHEX pathogenic variant; or</p> <p>Patient must have a confirmed diagnosis of X-linked hypophosphataemia demonstrated by the presence of all of the following: (i) a serum phosphate concentration below the age adjusted lower limit of normal; (ii) current or historical (for those with growth plate fusion) radiographic X-ray evidence of rickets; (iii) elevated (or inappropriately normal) serum or plasma FGF-23 levels of above the mean of the assay-specific reference range; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine; AND</p> <p>Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2022-11-01","N","4708"
"13383_13406_R","Continuing treatment","STREAMLINED","13406","13383","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to age-related macular degeneration (AMD); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to age-related macular degeneration (AMD); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13395_N","null","null","null","null","null","<p align=""justify"">Not for use in the treatment of sclerosing cholangitis or cholelithiasis.</p>","Y","N","N","null","null","N","2015-05-01","N","4708"
"13404_13336_R","Continuing treatment","STREAMLINED","13336","13404","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central retinal vein occlusion with macular oedema</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central retinal vein occlusion with macular oedema</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13407_13428_R","Continuing treatment","STREAMLINED","13428","13407","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetic macular oedema (DMO)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have had a cataract removed in the treated eye; or</p> <p>Patient must be scheduled for cataract surgery in the treated eye; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetic macular oedema (DMO)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have had a cataract removed in the treated eye; or</p> <p>Patient must be scheduled for cataract surgery in the treated eye; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13408_13392_R","Continuing treatment","STREAMLINED","13392","13408","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to pathologic myopia (PM); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to pathologic myopia (PM); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13411_13411_R","Continuing treatment","AUTHORITY_REQUIRED","13411","13411","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word ''cancelled'' where this occurs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word ''cancelled'' where this occurs.</p>","N","N","N","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13413_N","null","null","null","null","null","<p>Pharmaceutical benefits that have the form lansoprazole capsule 30 mg and pharmaceutical benefits that have the form lansoprazole tablet 30 mg (orally disintegrating) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"13414_13402_R","Continuing treatment","STREAMLINED","13402","13414","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetic macular oedema (DMO)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetic macular oedema (DMO)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13419_13419_R","Initial treatment covering the first 3 treatment cycles","AUTHORITY_REQUIRED","13419","13419","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC)</p><br/><p>Initial treatment covering the first 3 treatment cycles</p><br/><p>The condition must be unsuitable for each of: (i) curative surgical resection, (ii) curative radiotherapy; AND</p> <p>Patient must have had a WHO performance status of 0 or 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC)</p><br/><p>Initial treatment covering the first 3 treatment cycles</p><br/><p>The condition must be unsuitable for each of: (i) curative surgical resection, (ii) curative radiotherapy; AND</p> <p>Patient must have had a WHO performance status of 0 or 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13420_N","null","null","null","null","null","<p align=""justify"">Metronidazole has similar efficacy to vancomycin but may have less selective pressure to vancomycin resistant enterococci and is therefore the preferred treatment.</p>","Y","N","N","null","null","N","2015-05-01","N","4708"
"13421_13426_R","Continuing treatment","AUTHORITY_REQUIRED","13426","13421","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to age-related macular degeneration (AMD); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to age-related macular degeneration (AMD); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13428_N","null","null","null","null","null","<p align=""justify"">This drug has been reported to cause frequent and potentially serious toxicity.</p>","Y","N","N","null","null","N","2015-05-01","N","4708"
"13429_N","null","null","null","null","null","<p align=""justify"">Regular monitoring of hepatic and thyroid function is recommended.</p>","Y","N","N","null","null","N","2015-05-01","N","4708"
"13434_13434_R","Initial treatment","STREAMLINED","13434","13434","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of MET exon 14 skipping alterations in tumour material.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of MET exon 14 skipping alterations in tumour material.</p>","N","N","N","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13439_13432_R","Continuing treatment - 3 weekly treatment regimen","STREAMLINED","13432","13439","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first.</p>","N","N","N","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13440_13437_R","Continuing treatment - 6 weekly treatment regimen","STREAMLINED","13437","13440","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment - 6 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 18 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment - 6 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 18 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first.</p>","N","N","N","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13441_13441_R","Continuing treatment","STREAMLINED","13441","13441","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13442_13442_R","1,200 mg administered once every 3 weeks","STREAMLINED","13442","13442","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC)</p><br/><p>1,200 mg administered once every 3 weeks</p><br/><p>Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or</p> <p>Patient must be continuing existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND</p> <p>The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND</p> <p>The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words ''cancelled'' where (i)/(ii) has occurred.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC)</p><br/><p>1,200 mg administered once every 3 weeks</p><br/><p>Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or</p> <p>Patient must be continuing existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND</p> <p>The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND</p> <p>The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words ''cancelled'' where (i)/(ii) has occurred.</p>","N","N","N","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13451_13451_R","1,680 mg administered once every 4 weeks, or 840 mg every 2 weeks","STREAMLINED","13451","13451","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC)</p><br/><p>1,680 mg administered once every 4 weeks, or 840 mg every 2 weeks</p><br/><p>Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or</p> <p>Patient must be continuing existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND</p> <p>The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND</p> <p>The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words ''cancelled'' where (i)/(ii) has occurred.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC)</p><br/><p>1,680 mg administered once every 4 weeks, or 840 mg every 2 weeks</p><br/><p>Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or</p> <p>Patient must be continuing existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND</p> <p>The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND</p> <p>The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words ''cancelled'' where (i)/(ii) has occurred.</p>","N","N","N","IMMEDIATE","ALL","N","2022-11-01","N","4708"
"13470_13718_R","null","STREAMLINED","13718","13470","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Clinically definite relapsing-remitting multiple sclerosis</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.</p> <p>The date of the magnetic resonance imaging scan must be included in the patient&apos;s medical notes, unless written certification is provided, in the patient&apos;s medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.</p> <p/><p align=""justify"">Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.</p><p/> <p/><p align=""justify"">For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Clinically definite relapsing-remitting multiple sclerosis</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.</p> <p>The date of the magnetic resonance imaging scan must be included in the patient&apos;s medical notes, unless written certification is provided, in the patient&apos;s medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.</p> <p/><p align=""justify"">Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.</p><p/> <p/><p align=""justify"">For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13477_13497_R","Initial 3 - changing to this drug in combination therapy (dual or triple therapy)","AUTHORITY_REQUIRED","13497","13477","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 3 - changing to this drug in combination therapy (dual or triple therapy)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 3 - changing to this drug in combination therapy (dual or triple therapy)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13480_11229_R","Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag","AUTHORITY_REQUIRED","11229","13480","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag</p><br/><p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">The authority application for selexipag must be approved prior to the authority application for this agent.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align=""justify"">PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) is defined as follows:</p><p align=""justify"">(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or</p><p align=""justify"">(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.</p> <p align=""justify"">The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient&apos;s medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient&apos;s medical record.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag</p><br/><p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">The authority application for selexipag must be approved prior to the authority application for this agent.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align=""justify"">PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) is defined as follows:</p><p align=""justify"">(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or</p><p align=""justify"">(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.</p> <p align=""justify"">The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient&apos;s medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient&apos;s medical record.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p> <p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p>","N","N","Y","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13486_13569_R","Initial 3 - changing to this drug in combination therapy (dual or triple therapy)","AUTHORITY_REQUIRED","13569","13486","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 3 - changing to this drug in combination therapy (dual or triple therapy)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 3 - changing to this drug in combination therapy (dual or triple therapy)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13490_13575_R","Continuing treatment","AUTHORITY_REQUIRED","13575","13490","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13493_13491_R","Initial 2 (change)","AUTHORITY_REQUIRED","13491","13493","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 2 (change)</p><br/><p>Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH; AND</p> <p>Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Swapping between PAH agents: <br/>Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent&apos;s restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.</p><p align=""justify"">Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 2 (change)</p><br/><p>Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH; AND</p> <p>Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Swapping between PAH agents: <br/>Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent&apos;s restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.</p><p align=""justify"">Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13498_13497_R","Initial 3 - changing to this drug in combination therapy (dual or triple therapy)","AUTHORITY_REQUIRED","13497","13498","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 3 - changing to this drug in combination therapy (dual or triple therapy)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 3 - changing to this drug in combination therapy (dual or triple therapy)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">Where multiple strengths of this drug are sought, the combined number of repeats sought for each strength should not exceed 5. If the optimal strength is still to be determined by the end of the initial PBS supply, prescribers are reminded that further supplies of the optimal strength may be obtained via the Continuing treatment listing via a telephone/online authority application.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13501_13502_R","Continuing treatment","AUTHORITY_REQUIRED","13502","13501","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13504_13514_R","Initial 2 (change)","AUTHORITY_REQUIRED","13514","13504","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 2 (change)</p><br/><p>Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH; AND</p> <p>Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Swapping between PAH agents: <br/>Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent&apos;s restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.</p><p align=""justify"">Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.</p> <p align=""justify"">Approvals for prescriptions for dose titration will provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions.</p> <p align=""justify"">Approvals for subsequent authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 2 (change)</p><br/><p>Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH; AND</p> <p>Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Swapping between PAH agents: <br/>Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent&apos;s restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.</p><p align=""justify"">Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.</p> <p align=""justify"">Approvals for prescriptions for dose titration will provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions.</p> <p align=""justify"">Approvals for subsequent authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13511_13506_R","Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)","AUTHORITY_REQUIRED","13506","13511","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">If this authority application is to continue combination therapy, but with a change in at least one agent, the &apos;Initial 3 - change&apos; treatment phase restriction of the new drug(s) outlines the continuing eligibility of that new drug.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13513_13577_R","Continuing treatment","AUTHORITY_REQUIRED","13577","13513","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13561_13561_R","Continuing treatment","STREAMLINED","13561","13561","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated.</p>","N","N","N","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13578_13571_R","Continuing treatment","AUTHORITY_REQUIRED","13571","13578","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13615_N","null","null","null","null","null","<p align=""justify"">No applications for increased maximum quantities will be authorised.</p>","Y","N","N","null","null","N","2015-05-01","N","4708"
"13669_13572_R","Continuing treatment","AUTHORITY_REQUIRED","13572","13669","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13686_13624_R","Initial treatment","RESTRICTED","13624","13686","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central precocious puberty</p><br/><p>Initial treatment</p><br/><p>Must be treated by a paediatric endocrinologist; or</p> <p>Must be treated by an endocrinologist specialising in paediatrics; AND</p> <p>Patient must be of an age that is prior to their 10th birthday if female; or</p> <p>Patient must be of an age that is prior to their 11th birthday if male; AND</p> <p>Patient must have had onset of signs/symptoms of central precocious puberty prior to their 8th birthday if female; or</p> <p>Patient must have had onset of signs/symptoms of central precocious puberty prior to their 9th birthday if male.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central precocious puberty</p><br/><p>Initial treatment</p><br/><p>Must be treated by a paediatric endocrinologist; or</p> <p>Must be treated by an endocrinologist specialising in paediatrics; AND</p> <p>Patient must be of an age that is prior to their 10th birthday if female; or</p> <p>Patient must be of an age that is prior to their 11th birthday if male; AND</p> <p>Patient must have had onset of signs/symptoms of central precocious puberty prior to their 8th birthday if female; or</p> <p>Patient must have had onset of signs/symptoms of central precocious puberty prior to their 9th birthday if male.</p>","N","N","N","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13711_13625_R","null","STREAMLINED","13625","13711","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Clinically definite relapsing-remitting multiple sclerosis</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.</p> <p>The date of the magnetic resonance imaging scan must be included in the patient&apos;s medical notes, unless written certification is provided, in the patient&apos;s medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.</p> <p/><p align=""justify"">Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.</p><p/> <p/><p align=""justify"">For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Clinically definite relapsing-remitting multiple sclerosis</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.</p> <p>The date of the magnetic resonance imaging scan must be included in the patient&apos;s medical notes, unless written certification is provided, in the patient&apos;s medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.</p> <p/><p align=""justify"">Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.</p><p/> <p/><p align=""justify"">For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13721_13726_R","Initial treatment","STREAMLINED","13726","13721","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or Refractory Hodgkin lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT; or</p> <p>Patient must not be suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition; AND</p> <p>Patient must not have received prior treatment with a PD-1 (programmed cell death-1) inhibitor for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or Refractory Hodgkin lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT; or</p> <p>Patient must not be suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition; AND</p> <p>Patient must not have received prior treatment with a PD-1 (programmed cell death-1) inhibitor for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","N","N","N","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13722_13728_R","Initial treatment","AUTHORITY_REQUIRED","13728","13722","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must be untreated for this PBS indication (i.e untreated for each of: (i) unresectable disease, (ii) metastatic disease); AND</p> <p>Patient must not have received prior treatment for colorectal cancer with each of: (i) a programmed cell death-1 (PD-1) inhibitor, (ii) a programmed cell death ligand-1 (PD-L1) inhibitor; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must be untreated for this PBS indication (i.e untreated for each of: (i) unresectable disease, (ii) metastatic disease); AND</p> <p>Patient must not have received prior treatment for colorectal cancer with each of: (i) a programmed cell death-1 (PD-1) inhibitor, (ii) a programmed cell death ligand-1 (PD-L1) inhibitor; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","N","N","N","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13723_13731_R","Continuing treatment","STREAMLINED","13731","13723","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13724_13739_R","Initial treatment","STREAMLINED","13739","13724","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The condition must have progressed on or after prior platinum based chemotherapy; or</p> <p>The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer; or</p> <p>The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The condition must have progressed on or after prior platinum based chemotherapy; or</p> <p>The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer; or</p> <p>The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p> <p align=""justify"">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p>","N","N","N","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13725_13736_R","Continuing treatment","STREAMLINED","13736","13725","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13727_13727_R","Initial treatment","STREAMLINED","13727","13727","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory primary mediastinal B-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan; AND</p> <p>Patient must have been treated with rituximab-based chemotherapy for this condition; AND</p> <p>Patient must be experiencing relapsed/refractory disease; AND</p> <p>Patient must be autologous stem cell transplant (ASCT) ineligible following a single line of treatment; or</p> <p>Patient must have undergone an autologous stem cell transplant (ASCT); or</p> <p>Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must include rituximab-based chemotherapy; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory primary mediastinal B-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan; AND</p> <p>Patient must have been treated with rituximab-based chemotherapy for this condition; AND</p> <p>Patient must be experiencing relapsed/refractory disease; AND</p> <p>Patient must be autologous stem cell transplant (ASCT) ineligible following a single line of treatment; or</p> <p>Patient must have undergone an autologous stem cell transplant (ASCT); or</p> <p>Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must include rituximab-based chemotherapy; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","N","N","N","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13729_13730_R","Continuing treatment","AUTHORITY_REQUIRED","13730","13729","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13737_13741_R","Continuing treatment","STREAMLINED","13741","13737","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or Refractory Hodgkin lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or Refractory Hodgkin lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13740_13732_R","Continuing treatment","STREAMLINED","13732","13740","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory primary mediastinal B-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory primary mediastinal B-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2022-12-01","N","4708"
"13745_13745_R","Administration on Days 1, 8, 15 and 22 of six treatment cycles (28 days per cycle) in total","RESTRICTED","13745","13745","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Newly diagnosed systemic light chain amyloidosis</p><br/><p>Administration on Days 1, 8, 15 and 22 of six treatment cycles (28 days per cycle) in total</p><br/><p>Patient must be undergoing concurrent treatment with PBS-subsidised daratumumab for this PBS indication.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Newly diagnosed systemic light chain amyloidosis</p><br/><p>Administration on Days 1, 8, 15 and 22 of six treatment cycles (28 days per cycle) in total</p><br/><p>Patient must be undergoing concurrent treatment with PBS-subsidised daratumumab for this PBS indication.</p>","N","N","N","IMMEDIATE","ALL","N","2023-01-01","N","4708"
"13747_13768_R","Continuing treatment with triple therapy (this drug, bortezomib and dexamethasone)","AUTHORITY_REQUIRED","13768","13747","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment with triple therapy (this drug, bortezomib and dexamethasone)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment with triple therapy (this drug, bortezomib and dexamethasone)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2023-01-01","N","4708"
"13756_13757_R","Initial treatment with triple therapy (this drug, bortezomib and dexamethasone)","AUTHORITY_REQUIRED","13757","13756","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment with triple therapy (this drug, bortezomib and dexamethasone)</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy that is either: (i) lenalidomide monotherapy, (ii) contains lenalidomide; AND</p> <p>Patient must have undergone or be ineligible for a stem cell transplant.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment with triple therapy (this drug, bortezomib and dexamethasone)</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy that is either: (i) lenalidomide monotherapy, (ii) contains lenalidomide; AND</p> <p>Patient must have undergone or be ineligible for a stem cell transplant.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2023-01-01","N","4708"
"13763_13755_R","Continuing treatment - dual therapy in combination with dexamethasone","AUTHORITY_REQUIRED","13755","13763","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment - dual therapy in combination with dexamethasone</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment - dual therapy in combination with dexamethasone</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-01-01","N","4708"
"13764_13746_R","Initial treatment - dual therapy in combination with dexamethasone","AUTHORITY_REQUIRED","13746","13764","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment - dual therapy in combination with dexamethasone</p><br/><p>The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must have undergone or be ineligible for a primary stem cell transplant; AND</p> <p>Patient must have experienced treatment failure with lenalidomide, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information; AND</p> <p>Patient must have experienced treatment failure with bortezomib, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information.</p> <p align=""justify"">Bortezomib treatment failure is the absence of achieving at least a partial response or as progressive disease during treatment or within 6 months of discontinuing treatment with bortezomib. Lenalidomide treatment failure is progressive disease during treatment or within 6 months of discontinuing treatment with lenalidomide. </p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with lenalidomide, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to lenalidomide according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(2) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with bortezomib, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to bortezomib according to the relevant TGA-approved Product Information.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment - dual therapy in combination with dexamethasone</p><br/><p>The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must have undergone or be ineligible for a primary stem cell transplant; AND</p> <p>Patient must have experienced treatment failure with lenalidomide, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information; AND</p> <p>Patient must have experienced treatment failure with bortezomib, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information.</p> <p align=""justify"">Bortezomib treatment failure is the absence of achieving at least a partial response or as progressive disease during treatment or within 6 months of discontinuing treatment with bortezomib. Lenalidomide treatment failure is progressive disease during treatment or within 6 months of discontinuing treatment with lenalidomide. </p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with lenalidomide, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to lenalidomide according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(2) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with bortezomib, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to bortezomib according to the relevant TGA-approved Product Information.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-01-01","Y","4708"
"13774_13774_R","Continuing treatment from week 25 onwards (administered once every four weeks)","AUTHORITY_REQUIRED","13774","13774","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Newly diagnosed systemic light chain amyloidosis</p><br/><p>Continuing treatment from week 25 onwards (administered once every four weeks)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND</p> <p>Patient must be undergoing continuing treatment that does not extend treatment duration beyond whichever comes first: (i) disease progression, (ii) 96 cumulative weeks from the first administered dose, once in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Newly diagnosed systemic light chain amyloidosis</p><br/><p>Continuing treatment from week 25 onwards (administered once every four weeks)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND</p> <p>Patient must be undergoing continuing treatment that does not extend treatment duration beyond whichever comes first: (i) disease progression, (ii) 96 cumulative weeks from the first administered dose, once in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2023-01-01","N","4708"
"13783_13785_R","Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 21-day treatment cycle","AUTHORITY_REQUIRED","13785","13783","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 21-day treatment cycle</p><br/><p>The condition must be newly diagnosed; AND</p> <p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND</p> <p>Patient must not have been treated with lenalidomide or bortezomib for this condition; AND</p> <p>The treatment must not exceed a total of 4 cycles under this restriction.</p> <p align=""justify"">The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and</p><p align=""justify"">(2) nomination of which disease activity parameters will be used to assess response.</p><p align=""justify"">To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine - the percentage of plasma cells; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient&apos;s medical records.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 21-day treatment cycle</p><br/><p>The condition must be newly diagnosed; AND</p> <p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND</p> <p>Patient must not have been treated with lenalidomide or bortezomib for this condition; AND</p> <p>The treatment must not exceed a total of 4 cycles under this restriction.</p> <p align=""justify"">The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and</p><p align=""justify"">(2) nomination of which disease activity parameters will be used to assess response.</p><p align=""justify"">To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine - the percentage of plasma cells; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient&apos;s medical records.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-02-01","Y","4708"
"13784_13810_R","Initial treatment","AUTHORITY_REQUIRED","13810","13784","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic syndrome</p><br/><p>Initial treatment</p><br/><p>The treatment must be limited to a maximum duration of 16 weeks; AND</p> <p>Patient must be classified as Low risk or Intermediate-1 according to the International Prognostic Scoring System (IPSS); AND</p> <p>Patient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; AND</p> <p>Patient must be red blood cell transfusion dependent.</p> <p align=""justify"">Classification of a patient as Low risk requires a score of 0 on the IPSS, achieved with the following combination: less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias.</p> <p align=""justify"">Classification of a patient as Intermediate-1 requires a score of 0.5 to 1 on the IPSS, achieved with the following possible combinations:</p><p align=""justify"">1. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias; OR</p><p align=""justify"">2. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR</p><p align=""justify"">3. less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR</p><p align=""justify"">4. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 2/3 cytopenias; OR</p><p align=""justify"">5. 5%-10% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR</p><p align=""justify"">6. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR</p><p align=""justify"">7. less than 5% marrow blasts with poor karyotypic status (complex, greater than 3 abnormalities), and 0/1 cytopenias.</p> <p align=""justify"">Classification of a patient as red blood cell transfusion dependent requires that:</p><p align=""justify"">(i) the patient has been transfused within the last 8 weeks; and</p><p align=""justify"">(ii) the patient has received at least 8 units of red blood cell in the last 6 months prior to commencing PBS-subsidised therapy with lenalidomide; and would be expected to continue this requirement without lenalidomide treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has myelodysplastic syndrome; and</p><p align=""justify"">(b) details (date, unique identifying number/code or provider number) of the full blood examination report; and</p><p align=""justify"">(c) details (date, unique identifying number/code or provider number) of the pathology report and details of the cytogenetics demonstrating Low risk or Intermediate-1 disease according to the IPSS (note: using Fluorescence in Situ Hybridization (FISH) to demonstrate MDS -5q is acceptable); and</p><p align=""justify"">(d) details of transfusion requirements including: (i) the date of most recent transfusion and the number of red blood cell units transfused; and (ii) the total number of red blood cell units transfused in the 4 and 6 months preceding the date of this application.</p><p align=""justify"">All the reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS upload or mail, it must include:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic syndrome</p><br/><p>Initial treatment</p><br/><p>The treatment must be limited to a maximum duration of 16 weeks; AND</p> <p>Patient must be classified as Low risk or Intermediate-1 according to the International Prognostic Scoring System (IPSS); AND</p> <p>Patient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; AND</p> <p>Patient must be red blood cell transfusion dependent.</p> <p align=""justify"">Classification of a patient as Low risk requires a score of 0 on the IPSS, achieved with the following combination: less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias.</p> <p align=""justify"">Classification of a patient as Intermediate-1 requires a score of 0.5 to 1 on the IPSS, achieved with the following possible combinations:</p><p align=""justify"">1. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias; OR</p><p align=""justify"">2. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR</p><p align=""justify"">3. less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR</p><p align=""justify"">4. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 2/3 cytopenias; OR</p><p align=""justify"">5. 5%-10% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR</p><p align=""justify"">6. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR</p><p align=""justify"">7. less than 5% marrow blasts with poor karyotypic status (complex, greater than 3 abnormalities), and 0/1 cytopenias.</p> <p align=""justify"">Classification of a patient as red blood cell transfusion dependent requires that:</p><p align=""justify"">(i) the patient has been transfused within the last 8 weeks; and</p><p align=""justify"">(ii) the patient has received at least 8 units of red blood cell in the last 6 months prior to commencing PBS-subsidised therapy with lenalidomide; and would be expected to continue this requirement without lenalidomide treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has myelodysplastic syndrome; and</p><p align=""justify"">(b) details (date, unique identifying number/code or provider number) of the full blood examination report; and</p><p align=""justify"">(c) details (date, unique identifying number/code or provider number) of the pathology report and details of the cytogenetics demonstrating Low risk or Intermediate-1 disease according to the IPSS (note: using Fluorescence in Situ Hybridization (FISH) to demonstrate MDS -5q is acceptable); and</p><p align=""justify"">(d) details of transfusion requirements including: (i) the date of most recent transfusion and the number of red blood cell units transfused; and (ii) the total number of red blood cell units transfused in the 4 and 6 months preceding the date of this application.</p><p align=""justify"">All the reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS upload or mail, it must include:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2023-02-01","Y","4708"
"13788_13812_R","Initial treatment in combination with dexamethasone, of newly diagnosed disease in a patient ineligible for stem cell transplantation","AUTHORITY_REQUIRED","13812","13788","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment in combination with dexamethasone, of newly diagnosed disease in a patient ineligible for stem cell transplantation</p><br/><p>The condition must be newly diagnosed; AND</p> <p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must be ineligible for a primary stem cell transplantation; AND</p> <p>The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma, and</p><p align=""justify"">(2) confirmation of ineligibility for prior stem cell transplant; and</p><p align=""justify"">(3) nomination of which disease activity parameters will be used to assess response.</p><p align=""justify"">To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine - the percentage of plasma cells; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient&apos;s medical records.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment in combination with dexamethasone, of newly diagnosed disease in a patient ineligible for stem cell transplantation</p><br/><p>The condition must be newly diagnosed; AND</p> <p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must be ineligible for a primary stem cell transplantation; AND</p> <p>The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma, and</p><p align=""justify"">(2) confirmation of ineligibility for prior stem cell transplant; and</p><p align=""justify"">(3) nomination of which disease activity parameters will be used to assess response.</p><p align=""justify"">To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine - the percentage of plasma cells; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient&apos;s medical records.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-02-01","Y","4708"
"13789_13813_R","Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 and 6 (administered using 28-day treatment cycles)","AUTHORITY_REQUIRED","13813","13789","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 and 6 (administered using 28-day treatment cycles)</p><br/><p>Patient must have received PBS-subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND</p> <p>The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND</p> <p>The treatment must not exceed a total of 2 cycles under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 and 6 (administered using 28-day treatment cycles)</p><br/><p>Patient must have received PBS-subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND</p> <p>The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND</p> <p>The treatment must not exceed a total of 2 cycles under this restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-02-01","N","4708"
"13790_13791_R","Initial treatment with lenalidomide monotherapy in newly diagnosed disease","AUTHORITY_REQUIRED","13791","13790","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment with lenalidomide monotherapy in newly diagnosed disease</p><br/><p>The treatment must be as monotherapy; AND</p> <p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must have undergone an autologous stem cell transplant (ASCT) as part of frontline therapy for newly diagnosed multiple myeloma; AND</p> <p>Patient must not have progressive disease following autologous stem cell transplant (ASCT).</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and</p><p align=""justify"">(2) the date the autologous stem cell transplant was performed; and</p><p align=""justify"">(3) nomination of which disease activity parameters will be used to assess progression.</p><p align=""justify"">To enable confirmation of eligibility for treatment, the details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f) of at least one of the following must be provided:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine - the percentage of plasma cells; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters will be used to determine progression, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held in the patient&apos;s medical records.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment with lenalidomide monotherapy in newly diagnosed disease</p><br/><p>The treatment must be as monotherapy; AND</p> <p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must have undergone an autologous stem cell transplant (ASCT) as part of frontline therapy for newly diagnosed multiple myeloma; AND</p> <p>Patient must not have progressive disease following autologous stem cell transplant (ASCT).</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and</p><p align=""justify"">(2) the date the autologous stem cell transplant was performed; and</p><p align=""justify"">(3) nomination of which disease activity parameters will be used to assess progression.</p><p align=""justify"">To enable confirmation of eligibility for treatment, the details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f) of at least one of the following must be provided:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine - the percentage of plasma cells; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters will be used to determine progression, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held in the patient&apos;s medical records.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-02-01","Y","4708"
"13792_13787_R","Continuing treatment until progression in patients initiated on dual combination therapy (this drug and dexamethasone), or, in patients initiated on triple therapy (this drug, bortezomib and dexamethasone during treatment cycles 1 up to 8) and are now being treated with treatment cycle 9 or beyond","AUTHORITY_REQUIRED","13787","13792","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment until progression in patients initiated on dual combination therapy (this drug and dexamethasone), or, in patients initiated on triple therapy (this drug, bortezomib and dexamethasone during treatment cycles 1 up to 8) and are now being treated with treatment cycle 9 or beyond</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment until progression in patients initiated on dual combination therapy (this drug and dexamethasone), or, in patients initiated on triple therapy (this drug, bortezomib and dexamethasone during treatment cycles 1 up to 8) and are now being treated with treatment cycle 9 or beyond</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-02-01","N","4708"
"13793_13811_R","Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 to 8 inclusive (administered using 21-day treatment cycles)","AUTHORITY_REQUIRED","13811","13793","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 to 8 inclusive (administered using 21-day treatment cycles)</p><br/><p>Patient must have received PBS-subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND</p> <p>The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND</p> <p>The treatment must not exceed a total of 4 cycles under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 to 8 inclusive (administered using 21-day treatment cycles)</p><br/><p>Patient must have received PBS-subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND</p> <p>The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND</p> <p>The treatment must not exceed a total of 4 cycles under this restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-02-01","N","4708"
"13794_13786_R","Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 28-day treatment cycle","AUTHORITY_REQUIRED","13786","13794","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 28-day treatment cycle</p><br/><p>The condition must be newly diagnosed; AND</p> <p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND</p> <p>Patient must not have been treated with lenalidomide or bortezomib for this condition; AND</p> <p>The treatment must not exceed a total of 4 cycles under this restriction.</p> <p align=""justify"">The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and</p><p align=""justify"">(2) nomination of which disease activity parameters will be used to assess response.</p><p align=""justify"">To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine - the percentage of plasma cells; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient&apos;s medical records.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 28-day treatment cycle</p><br/><p>The condition must be newly diagnosed; AND</p> <p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND</p> <p>Patient must not have been treated with lenalidomide or bortezomib for this condition; AND</p> <p>The treatment must not exceed a total of 4 cycles under this restriction.</p> <p align=""justify"">The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and</p><p align=""justify"">(2) nomination of which disease activity parameters will be used to assess response.</p><p align=""justify"">To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine - the percentage of plasma cells; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient&apos;s medical records.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-02-01","Y","4708"
"13798_13801_R","Continuing treatment","AUTHORITY_REQUIRED","13801","13798","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised initial therapy with lenalidomide for myelodysplastic syndrome; AND</p> <p>Patient must have achieved and maintained transfusion independence; or at least a 50% reduction in red blood cell unit transfusion requirements compared with the four month period prior to commencing initial PBS-subsidised therapy with lenalidomide; AND</p> <p>Patient must not have progressive disease; AND</p> <p>The condition must not have progressed to acute myeloid leukaemia.</p> <p align=""justify"">The first authority application for continuing supply must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. Subsequent authority applications for continuing supply may be made via the Online PBS Authorities System or by telephone.</p><p align=""justify"">The following evidence of response must be provided at each application:</p><p align=""justify"">(i) a haemoglobin level taken within the last 4 weeks; and</p><p align=""justify"">(ii) the date of the last transfusion; and</p><p align=""justify"">(iii) a statement of the number of units of red cells transfused in the 4 months immediately preceding this application;</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">For first continuing applications, if the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised initial therapy with lenalidomide for myelodysplastic syndrome; AND</p> <p>Patient must have achieved and maintained transfusion independence; or at least a 50% reduction in red blood cell unit transfusion requirements compared with the four month period prior to commencing initial PBS-subsidised therapy with lenalidomide; AND</p> <p>Patient must not have progressive disease; AND</p> <p>The condition must not have progressed to acute myeloid leukaemia.</p> <p align=""justify"">The first authority application for continuing supply must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. Subsequent authority applications for continuing supply may be made via the Online PBS Authorities System or by telephone.</p><p align=""justify"">The following evidence of response must be provided at each application:</p><p align=""justify"">(i) a haemoglobin level taken within the last 4 weeks; and</p><p align=""justify"">(ii) the date of the last transfusion; and</p><p align=""justify"">(iii) a statement of the number of units of red cells transfused in the 4 months immediately preceding this application;</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">For first continuing applications, if the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2023-02-01","Y","4708"
"13798_N","null","null","null","null","null","<p align=""justify"">No applications for increased maximum quantities and/or repeats will be authorised for the 120 mg powder for injection.</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"13799_13803_R","Initial treatment as monotherapy or dual combination therapy with dexamethasone for progressive disease","AUTHORITY_REQUIRED","13803","13799","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment as monotherapy or dual combination therapy with dexamethasone for progressive disease</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must have undergone or be ineligible for a primary stem cell transplant.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and</p><p align=""justify"">(2) prior treatments including name(s) of drug(s) and date of most recent treatment cycle; and</p><p align=""justify"">(3) date of prior stem cell transplant or confirmation of ineligibility for prior stem cell transplant; and</p><p align=""justify"">(4) details of the basis of the diagnosis of progressive disease or failure to respond; and</p><p align=""justify"">(5) nomination of which disease activity parameters will be used to assess response.</p><p align=""justify"">To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine - the percentage of plasma cells; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held in the patient&apos;s medical records.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Initial treatment as monotherapy or dual combination therapy with dexamethasone for progressive disease</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must have undergone or be ineligible for a primary stem cell transplant.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and</p><p align=""justify"">(2) prior treatments including name(s) of drug(s) and date of most recent treatment cycle; and</p><p align=""justify"">(3) date of prior stem cell transplant or confirmation of ineligibility for prior stem cell transplant; and</p><p align=""justify"">(4) details of the basis of the diagnosis of progressive disease or failure to respond; and</p><p align=""justify"">(5) nomination of which disease activity parameters will be used to assess response.</p><p align=""justify"">To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine - the percentage of plasma cells; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held in the patient&apos;s medical records.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-02-01","Y","4708"
"13800_13805_R","Continuing treatment as monotherapy or dual combination therapy with dexamethasone following initial treatment for progressive disease","AUTHORITY_REQUIRED","13805","13800","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment as monotherapy or dual combination therapy with dexamethasone following initial treatment for progressive disease</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for relapsed or refractory multiple myeloma; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment as monotherapy or dual combination therapy with dexamethasone following initial treatment for progressive disease</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for relapsed or refractory multiple myeloma; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-02-01","N","4708"
"13802_13804_R","Continuing treatment with lenalidomide monotherapy following initial treatment with lenalidomide therapy in newly diagnosed disease","AUTHORITY_REQUIRED","13804","13802","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment with lenalidomide monotherapy following initial treatment with lenalidomide therapy in newly diagnosed disease</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be as monotherapy.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p><br/><p>Continuing treatment with lenalidomide monotherapy following initial treatment with lenalidomide therapy in newly diagnosed disease</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be as monotherapy.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-02-01","N","4708"
"13804_N","null","null","null","null","null","<p>For item codes 2110C and 1880Y, pharmaceutical benefits that have the form tablet 20 mg (base) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"13806_13782_R","Triple combination therapy consisting of elotuzumab, lenalidomide and dexamethasone","AUTHORITY_REQUIRED","13782","13806","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Triple combination therapy consisting of elotuzumab, lenalidomide and dexamethasone</p><br/><p>Patient must be undergoing concurrent treatment with elotuzumab obtained through the PBS; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Triple combination therapy consisting of elotuzumab, lenalidomide and dexamethasone</p><br/><p>Patient must be undergoing concurrent treatment with elotuzumab obtained through the PBS; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-02-01","N","4708"
"13808_N","null","null","null","null","null","<p align=""justify"">Prescribing of drugs of addiction by dentists is not permitted in some States/Territories.</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"13828_12101_R","Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) - balance of supply","AUTHORITY_REQUIRED","12101","13828","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-03-01","N","4708"
"13834_12147_R","Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","12147","13834","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have an externally draining enterocutaneous or rectovaginal fistula.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) two completed authority prescription forms; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition of no more than 4 weeks old at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have an externally draining enterocutaneous or rectovaginal fistula.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) two completed authority prescription forms; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition of no more than 4 weeks old at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this biological medicine.</p><p align=""justify""><b>Prescribing the 40 mg presentation:</b></p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats.</p><p align=""justify""><b>Prescribing the 80 mg presentation:</b></p><p align=""justify"">One prescription should be for the 80 mg presentation with a quantity of 3 units and zero repeats. This will enable doses at week 0 and week 2 to be completed. The second prescription should be written for 2 doses of 40 mg and 2 repeats.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-03-01","Y","4708"
"13848_13650_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","13650","13848","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-03-01","Y","4708"
"13849_12098_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","12098","13849","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) two completed authority prescription forms; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological medicine treatment including details of date and duration of treatment.</p> <p align=""justify"">The most recent fistula assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) two completed authority prescription forms; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological medicine treatment including details of date and duration of treatment.</p> <p align=""justify"">The most recent fistula assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this biological medicine.</p><p align=""justify""><b>Prescribing the 40 mg presentation:</b></p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats.</p><p align=""justify""><b>Prescribing the 80 mg presentation:</b></p><p align=""justify"">One prescription should be for the 80 mg presentation with a quantity of 3 units and zero repeats. This will enable doses at week 0 and week 2 to be completed. The second prescription should be written for 2 doses of 40 mg and 2 repeats.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-03-01","Y","4708"
"13860_13694_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","13694","13860","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-03-01","Y","4708"
"13867_13867_R","Continuing treatment","STREAMLINED","13867","13867","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe chronic graft versus host disease (cGVHD)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have responding disease at 24 weeks compared with baseline, demonstrated by either a: (i) partial response, (ii) complete response; AND</p> <p>The treatment must be the sole PBS-subsidised treatment for this condition with the exception of: (i) corticosteroids, (ii) calcineurin inhibitors; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.</p> <p align=""justify"">Response is defined as attaining a complete or partial response as defined by the <i>National Institutes of Health </i>(NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib.</p><p align=""justify"">(a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy.</p><p align=""justify"">(b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies.</p><p align=""justify"">The assessment of response must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe chronic graft versus host disease (cGVHD)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have responding disease at 24 weeks compared with baseline, demonstrated by either a: (i) partial response, (ii) complete response; AND</p> <p>The treatment must be the sole PBS-subsidised treatment for this condition with the exception of: (i) corticosteroids, (ii) calcineurin inhibitors; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.</p> <p align=""justify"">Response is defined as attaining a complete or partial response as defined by the <i>National Institutes of Health </i>(NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib.</p><p align=""justify"">(a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy.</p><p align=""justify"">(b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies.</p><p align=""justify"">The assessment of response must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13869_13912_R","Subsequent continuing","AUTHORITY_REQUIRED","13912","13869","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>Subsequent continuing</p><br/><p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must be undergoing regular phenylalanine testing and assessment of adherence to dietary modifications.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>Subsequent continuing</p><br/><p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must be undergoing regular phenylalanine testing and assessment of adherence to dietary modifications.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13870_13900_R","null","AUTHORITY_REQUIRED","13900","13870","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adjuvant treatment of stage II or III oesophageal cancer or gastro-oesophageal junction cancer</p><br/><p>The condition must have histological evidence confirming a diagnosis of a least one of: (i) adenocarcinoma, (ii) squamous cell cancer; document this evidence in the patient''s medical records; AND</p> <p>The condition must have been treated with neoadjuvant platinum-based chemoradiotherapy; AND</p> <p>The treatment must be for the purposes of adjuvant use following complete surgical resection that occurred within 16 weeks prior to initiating this drug; AND</p> <p>The condition must have evidence, through resected specimen, that residual disease meets the Tumour Nodes Metastases (TNM) staging system (as published by the Union for International Cancer Control) of either: (i) at least ypT1, (ii) at least ypN1; document this evidence in the patient''s medical records; AND</p> <p>Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be undergoing treatment with a dosing regimen as set out in the drug''s approved Australian Product Information; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment with this drug where this prescription extends treatment beyond whichever comes first: (i) 12 months from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease recurrence despite treatment with this drug; annotate any remaining repeat prescriptions with the word ''cancelled'' where this occurs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adjuvant treatment of stage II or III oesophageal cancer or gastro-oesophageal junction cancer</p><br/><p>The condition must have histological evidence confirming a diagnosis of a least one of: (i) adenocarcinoma, (ii) squamous cell cancer; document this evidence in the patient''s medical records; AND</p> <p>The condition must have been treated with neoadjuvant platinum-based chemoradiotherapy; AND</p> <p>The treatment must be for the purposes of adjuvant use following complete surgical resection that occurred within 16 weeks prior to initiating this drug; AND</p> <p>The condition must have evidence, through resected specimen, that residual disease meets the Tumour Nodes Metastases (TNM) staging system (as published by the Union for International Cancer Control) of either: (i) at least ypT1, (ii) at least ypN1; document this evidence in the patient''s medical records; AND</p> <p>Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be undergoing treatment with a dosing regimen as set out in the drug''s approved Australian Product Information; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment with this drug where this prescription extends treatment beyond whichever comes first: (i) 12 months from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease recurrence despite treatment with this drug; annotate any remaining repeat prescriptions with the word ''cancelled'' where this occurs.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13874_9268_R","null","STREAMLINED","9268","13874","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13878_13885_R","Initial treatment - responsiveness testing","AUTHORITY_REQUIRED","13885","13878","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>Initial treatment - responsiveness testing</p><br/><p>Must be treated by a metabolic physician; AND</p> <p>Patient must be untreated with this drug; or</p> <p>Patient must have completed prior responsiveness testing on only 1 occasion - this occurred when the patient was less than 1 month of age, but this benefit is for a second attempt at responsiveness testing in a patient aged at least 1 month old; AND</p> <p>Patient must have a baseline blood phenylalanine level above 360 micromole per L and be less than one month of age; or</p> <p>Patient must have a baseline blood phenylalanine level above 600 micromole per L and be more than one month of age; AND</p> <p>The treatment must be for the purpose of initial responsiveness testing for a period of 24 hours in a patient less than one month of age; or</p> <p>The treatment must be for the purpose of initial responsiveness testing for a period of 7 days in a patient aged more than one month.</p> <p align=""justify"">Dietary phenylalanine intake must be maintained at a constant level.</p> <p align=""justify"">Patients or their parent/guardian should be assessed for their ability to comply with the sapropterin protocol and PKU diet prior to conducting initial responsiveness testing.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>Initial treatment - responsiveness testing</p><br/><p>Must be treated by a metabolic physician; AND</p> <p>Patient must be untreated with this drug; or</p> <p>Patient must have completed prior responsiveness testing on only 1 occasion - this occurred when the patient was less than 1 month of age, but this benefit is for a second attempt at responsiveness testing in a patient aged at least 1 month old; AND</p> <p>Patient must have a baseline blood phenylalanine level above 360 micromole per L and be less than one month of age; or</p> <p>Patient must have a baseline blood phenylalanine level above 600 micromole per L and be more than one month of age; AND</p> <p>The treatment must be for the purpose of initial responsiveness testing for a period of 24 hours in a patient less than one month of age; or</p> <p>The treatment must be for the purpose of initial responsiveness testing for a period of 7 days in a patient aged more than one month.</p> <p align=""justify"">Dietary phenylalanine intake must be maintained at a constant level.</p> <p align=""justify"">Patients or their parent/guardian should be assessed for their ability to comply with the sapropterin protocol and PKU diet prior to conducting initial responsiveness testing.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13879_13880_R","First continuing treatment","AUTHORITY_REQUIRED","13880","13879","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must have previously received PBS-subsidised treatment under the Initial treatment - responsiveness testing restriction with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to treatment with this drug of greater than or equal to a 30% reduction in phenylalanine levels from baseline during initial responsiveness testing.</p> <p align=""justify"">Blood phenylalanine levels must be based on measurements taken during stable periods of the condition.</p> <p align=""justify"">Dietary phenylalanine intake must be maintained at a constant level.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must have previously received PBS-subsidised treatment under the Initial treatment - responsiveness testing restriction with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to treatment with this drug of greater than or equal to a 30% reduction in phenylalanine levels from baseline during initial responsiveness testing.</p> <p align=""justify"">Blood phenylalanine levels must be based on measurements taken during stable periods of the condition.</p> <p align=""justify"">Dietary phenylalanine intake must be maintained at a constant level.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13884_13911_R","Initial treatment","STREAMLINED","13911","13884","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Grade II to IV acute graft versus host disease (aGVHD)</p><br/><p>Initial treatment</p><br/><p>Patient must have received prior systemic steroid treatment for this condition; AND</p> <p>Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.</p> <p align=""justify"">The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016).</p> <p align=""justify"">Steroid-refractory disease is defined as:</p><p align=""justify"">(a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or</p><p align=""justify"">(b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD.</p><p align=""justify"">Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria:</p><p align=""justify"">(a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or</p><p align=""justify"">(b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.</p><p align=""justify"">Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.</p><p align=""justify"">Details of prior steroid use should be documented in the patient&apos;s medical records.</p> <p align=""justify"">A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment.</p> <p align=""justify"">Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.</p><p align=""justify"">(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.</p><p align=""justify"">(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.</p><p align=""justify"">The assessment of response must be documented in the patient&apos;s medical records.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Grade II to IV acute graft versus host disease (aGVHD)</p><br/><p>Initial treatment</p><br/><p>Patient must have received prior systemic steroid treatment for this condition; AND</p> <p>Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.</p> <p align=""justify"">The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016).</p> <p align=""justify"">Steroid-refractory disease is defined as:</p><p align=""justify"">(a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or</p><p align=""justify"">(b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD.</p><p align=""justify"">Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria:</p><p align=""justify"">(a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or</p><p align=""justify"">(b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.</p><p align=""justify"">Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.</p><p align=""justify"">Details of prior steroid use should be documented in the patient&apos;s medical records.</p> <p align=""justify"">A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment.</p> <p align=""justify"">Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.</p><p align=""justify"">(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.</p><p align=""justify"">(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.</p><p align=""justify"">The assessment of response must be documented in the patient&apos;s medical records.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13889_5703_R","null","STREAMLINED","5703","13889","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to castration-resistant prostate cancer.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to castration-resistant prostate cancer.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13892_13892_R","Continuing treatment","STREAMLINED","13892","13892","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Grade II to IV acute graft versus host disease (aGVHD)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.</p> <p align=""justify"">Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.</p><p align=""justify"">(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.</p><p align=""justify"">(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.</p><p align=""justify"">The assessment of response must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Grade II to IV acute graft versus host disease (aGVHD)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.</p> <p align=""justify"">Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.</p><p align=""justify"">(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.</p><p align=""justify"">(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.</p><p align=""justify"">The assessment of response must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13897_5605_R","null","STREAMLINED","5605","13897","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to breast cancer.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to breast cancer.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13899_13865_R","Continuing treatment","AUTHORITY_REQUIRED","13865","13899","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic rhinosinusitis with nasal polyps (CRSwNP)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have both demonstrated and sustained an adequate response to this drug, defined as having at least one of: (i) an improvement in bilateral endoscopic nasal polyp score of at least 1.0 compared to the baseline level provided with the initial authority application, (ii) an improvement in nasal obstruction visual analogue scale (VAS) score of at least 3.0 compared to the baseline level provided with the initial authority application, (iii) an improvement in overall symptom VAS score of at least 2.5 compared to the baseline level provided with the initial authority application; AND</p> <p>Patient must be at least 18 years of age.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic rhinosinusitis with nasal polyps (CRSwNP)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have both demonstrated and sustained an adequate response to this drug, defined as having at least one of: (i) an improvement in bilateral endoscopic nasal polyp score of at least 1.0 compared to the baseline level provided with the initial authority application, (ii) an improvement in nasal obstruction visual analogue scale (VAS) score of at least 3.0 compared to the baseline level provided with the initial authority application, (iii) an improvement in overall symptom VAS score of at least 2.5 compared to the baseline level provided with the initial authority application; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13902_9328_R","null","STREAMLINED","9328","13902","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to breast cancer.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to breast cancer.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13903_5735_R","null","STREAMLINED","5735","13903","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13906_13906_R","Initial treatment","STREAMLINED","13906","13906","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe chronic graft versus host disease (cGVHD)</p><br/><p>Initial treatment</p><br/><p>Patient must have received prior systemic steroid treatment for this condition; AND</p> <p>Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND</p> <p>The treatment must be the sole PBS-subsidised treatment for this condition with the exception of: (i) corticosteroids, (ii) calcineurin inhibitors; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation.</p> <p align=""justify"">The severity of cGVHD is defined by the <i>National Institutes of Health</i> (NIH) criteria (Jagasia et al., 2015):</p><p align=""justify"">(a) Moderate cGVHD: at least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1</p><p align=""justify"">(b) Severe cGVHD: at least 1 organ with a score of 3, or lung score of 2 or 3</p> <p align=""justify"">Steroid-refractory disease is defined as:</p><p align=""justify"">(a) a lack of response or disease progression after administration of a minimum prednisone dose of 1 mg/kg/day for at least 1 week (or equivalent); or</p><p align=""justify"">(b) disease persistence without improvement despite continued treatment with prednisone at greater than 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent).</p><p align=""justify"">Steroid-dependent disease is defined as an increased prednisone dose to greater than 0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent).</p><p align=""justify"">Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.</p><p align=""justify"">Details of prior steroid use should be documented in the patient&apos;s medical records.</p> <p align=""justify"">A patient must demonstrate a response 24 weeks after initiating treatment with ruxolitinib to be eligible for continuing treatment.</p> <p align=""justify"">Response is defined as attaining a complete or partial response as defined by the <i>National Institutes of Health </i>(NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib.</p><p align=""justify"">(a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy.</p><p align=""justify"">(b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies.</p><p align=""justify"">The assessment of response must be documented in the patient&apos;s medical records.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe chronic graft versus host disease (cGVHD)</p><br/><p>Initial treatment</p><br/><p>Patient must have received prior systemic steroid treatment for this condition; AND</p> <p>Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND</p> <p>The treatment must be the sole PBS-subsidised treatment for this condition with the exception of: (i) corticosteroids, (ii) calcineurin inhibitors; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation.</p> <p align=""justify"">The severity of cGVHD is defined by the <i>National Institutes of Health</i> (NIH) criteria (Jagasia et al., 2015):</p><p align=""justify"">(a) Moderate cGVHD: at least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1</p><p align=""justify"">(b) Severe cGVHD: at least 1 organ with a score of 3, or lung score of 2 or 3</p> <p align=""justify"">Steroid-refractory disease is defined as:</p><p align=""justify"">(a) a lack of response or disease progression after administration of a minimum prednisone dose of 1 mg/kg/day for at least 1 week (or equivalent); or</p><p align=""justify"">(b) disease persistence without improvement despite continued treatment with prednisone at greater than 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent).</p><p align=""justify"">Steroid-dependent disease is defined as an increased prednisone dose to greater than 0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent).</p><p align=""justify"">Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.</p><p align=""justify"">Details of prior steroid use should be documented in the patient&apos;s medical records.</p> <p align=""justify"">A patient must demonstrate a response 24 weeks after initiating treatment with ruxolitinib to be eligible for continuing treatment.</p> <p align=""justify"">Response is defined as attaining a complete or partial response as defined by the <i>National Institutes of Health </i>(NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib.</p><p align=""justify"">(a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy.</p><p align=""justify"">(b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies.</p><p align=""justify"">The assessment of response must be documented in the patient&apos;s medical records.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13907_13907_R","Initial treatment","STREAMLINED","13907","13907","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Grade II to IV acute graft versus host disease (aGVHD)</p><br/><p>Initial treatment</p><br/><p>Patient must have received prior systemic steroid treatment for this condition; AND</p> <p>Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.</p> <p align=""justify"">The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016).</p> <p align=""justify"">Steroid-refractory disease is defined as:</p><p align=""justify"">(a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or</p><p align=""justify"">(b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD.</p><p align=""justify"">Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria:</p><p align=""justify"">(a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or</p><p align=""justify"">(b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.</p><p align=""justify"">Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.</p><p align=""justify"">Details of prior steroid use should be documented in the patient&apos;s medical records.</p> <p align=""justify"">A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment.</p> <p align=""justify"">Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.</p><p align=""justify"">(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.</p><p align=""justify"">(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.</p><p align=""justify"">The assessment of response must be documented in the patient&apos;s medical records.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Grade II to IV acute graft versus host disease (aGVHD)</p><br/><p>Initial treatment</p><br/><p>Patient must have received prior systemic steroid treatment for this condition; AND</p> <p>Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.</p> <p align=""justify"">The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016).</p> <p align=""justify"">Steroid-refractory disease is defined as:</p><p align=""justify"">(a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or</p><p align=""justify"">(b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD.</p><p align=""justify"">Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria:</p><p align=""justify"">(a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or</p><p align=""justify"">(b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.</p><p align=""justify"">Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.</p><p align=""justify"">Details of prior steroid use should be documented in the patient&apos;s medical records.</p> <p align=""justify"">A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment.</p> <p align=""justify"">Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.</p><p align=""justify"">(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.</p><p align=""justify"">(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.</p><p align=""justify"">The assessment of response must be documented in the patient&apos;s medical records.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13908_13876_R","Continuing treatment","STREAMLINED","13876","13908","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Grade II to IV acute graft versus host disease (aGVHD)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.</p> <p align=""justify"">Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.</p><p align=""justify"">(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.</p><p align=""justify"">(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.</p><p align=""justify"">The assessment of response must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Grade II to IV acute graft versus host disease (aGVHD)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.</p> <p align=""justify"">Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.</p><p align=""justify"">(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.</p><p align=""justify"">(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.</p><p align=""justify"">The assessment of response must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13909_13868_R","Initial treatment - responsiveness testing","AUTHORITY_REQUIRED","13868","13909","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>Initial treatment - responsiveness testing</p><br/><p>The treatment must be for the purpose of ascertaining the patient''s response to treatment over a period of 7 days, with the intent to then use the drug to control phenylalanine levels under the treatment phase: First continuing treatment, Indication: Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU); AND</p> <p>Patient must have a baseline blood phenylalanine level above 250 micromol/L prior to commencing treatment with this drug despite best efforts to rely on dietary modifications to control phenylalanine levels; AND</p> <p>Must be treated by a metabolic physician; AND</p> <p>Patient must be undergoing treatment with this drug for the first time; AND</p> <p>Patient must not be undergoing treatment with this drug under this Treatment phase, more than once per lifetime following completion of this authority application; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug under another PBS-listing (apply under either listing type, but not both simultaneously); AND</p> <p>Patient must be one of: (i) planning conception, (ii) pregnant.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>Initial treatment - responsiveness testing</p><br/><p>The treatment must be for the purpose of ascertaining the patient''s response to treatment over a period of 7 days, with the intent to then use the drug to control phenylalanine levels under the treatment phase: First continuing treatment, Indication: Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU); AND</p> <p>Patient must have a baseline blood phenylalanine level above 250 micromol/L prior to commencing treatment with this drug despite best efforts to rely on dietary modifications to control phenylalanine levels; AND</p> <p>Must be treated by a metabolic physician; AND</p> <p>Patient must be undergoing treatment with this drug for the first time; AND</p> <p>Patient must not be undergoing treatment with this drug under this Treatment phase, more than once per lifetime following completion of this authority application; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug under another PBS-listing (apply under either listing type, but not both simultaneously); AND</p> <p>Patient must be one of: (i) planning conception, (ii) pregnant.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13914_9304_R","null","STREAMLINED","9304","13914","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to castration-resistant prostate cancer.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to castration-resistant prostate cancer.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13915_9317_R","null","STREAMLINED","9317","13915","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia of malignancy</p><br/><p>Patient must have a malignancy refractory to anti-neoplastic therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia of malignancy</p><br/><p>Patient must have a malignancy refractory to anti-neoplastic therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13915_N","null","null","null","null","null","<p align=""justify"">Telephone approvals are limited to 1 month&apos;s therapy.</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"13916_5704_R","null","STREAMLINED","5704","13916","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia of malignancy</p><br/><p>Patient must have a malignancy refractory to anti-neoplastic therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia of malignancy</p><br/><p>Patient must have a malignancy refractory to anti-neoplastic therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13916_N","null","null","null","null","null","<p align=""justify"">Regular monitoring of drug serum levels is recommended.</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"13919_13920_R","null","AUTHORITY_REQUIRED","13920","13919","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human immunodeficiency virus (HIV) infection</p><br/><p>Patient must be less than 13.00 years of age; AND</p> <p>Patient must be unable to take a solid dose form of this drug; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human immunodeficiency virus (HIV) infection</p><br/><p>Patient must be less than 13.00 years of age; AND</p> <p>Patient must be unable to take a solid dose form of this drug; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>","N","N","N","IMMEDIATE","ALL","N","2023-04-01","N","4708"
"13923_13923_R","Continuing treatment for patients without T315I mutation","STREAMLINED","13923","13923","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment for patients without T315I mutation</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%; or</p> <p>Patient must be undergoing subsequent continuing treatment with this drug, demonstrating a 12-month response of either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment for patients without T315I mutation</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%; or</p> <p>Patient must be undergoing subsequent continuing treatment with this drug, demonstrating a 12-month response of either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13928_13998_R","Continuing treatment","AUTHORITY_REQUIRED","13998","13928","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Achondroplasia</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS subsidised vosoritide treatment for this condition; AND</p> <p>Patient must not have evidence of growth plate closure demonstrated by at least one of the following: i) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 6 months of this application if puberty has commenced; ii) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 2 years of commencing treatment if puberty has not commenced; iii) an annual growth velocity of greater than 1.5 cm/year as assessed over a period of at least 6 months; AND</p> <p>Must be treated by a medical specialist, experienced in the management of achondroplasia; or</p> <p>Must be treated by a paediatrician in consultation with a medical specialist experienced in the management of achondroplasia.</p> <p align=""justify"">In patients where puberty has not commenced, radiographic evidence that epiphyses have not closed must be obtained within 2 years of commencing treatment with vosoritide. X-rays and dates (date commenced treatment and date of X-ray) must be documented in the patient&apos;s medical records.</p><p align=""justify"">Additional radiographic evidence is not required until patient has begun puberty.</p><p align=""justify"">In patients where puberty has commenced, radiographic evidence that epiphyses have not closed must be obtained within 6 months of completing an authority application for vosoritide. X-ray and date taken must be documented in the patient&apos;s medical records.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Achondroplasia</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS subsidised vosoritide treatment for this condition; AND</p> <p>Patient must not have evidence of growth plate closure demonstrated by at least one of the following: i) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 6 months of this application if puberty has commenced; ii) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 2 years of commencing treatment if puberty has not commenced; iii) an annual growth velocity of greater than 1.5 cm/year as assessed over a period of at least 6 months; AND</p> <p>Must be treated by a medical specialist, experienced in the management of achondroplasia; or</p> <p>Must be treated by a paediatrician in consultation with a medical specialist experienced in the management of achondroplasia.</p> <p align=""justify"">In patients where puberty has not commenced, radiographic evidence that epiphyses have not closed must be obtained within 2 years of commencing treatment with vosoritide. X-rays and dates (date commenced treatment and date of X-ray) must be documented in the patient&apos;s medical records.</p><p align=""justify"">Additional radiographic evidence is not required until patient has begun puberty.</p><p align=""justify"">In patients where puberty has commenced, radiographic evidence that epiphyses have not closed must be obtained within 6 months of completing an authority application for vosoritide. X-ray and date taken must be documented in the patient&apos;s medical records.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2023-05-01","N","4708"
"13931_14011_R","Continuing treatment","AUTHORITY_REQUIRED","14011","13931","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a dose strength change is required, see &apos;Dose modification&apos; treatment phase to continue treatment at a new dose strength.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13935_13938_R","Continuing","STREAMLINED","13938","13935","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderately severe Alzheimer disease</p><br/><p>Continuing</p><br/><p>Patient must have received six months of sole PBS-subsidised initial therapy with this drug; AND</p> <p>Patient must demonstrate a clinically meaningful response to the initial treatment; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient&apos;s family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit.</p><p align=""justify"">Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use.</p> <p align=""justify"">Re-assessments for a clinically meaningful response are to be undertaken and documented every six months.</p><p align=""justify"">Clinically meaningful response to treatment is demonstrated in the following areas: </p><p align=""justify"">Patient&apos;s quality of life including but not limited to level of independence and happiness; </p><p align=""justify"">Patient&apos;s cognitive function including but not limited to memory, recognition and interest in environment; </p><p align=""justify"">Patient&apos;s behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderately severe Alzheimer disease</p><br/><p>Continuing</p><br/><p>Patient must have received six months of sole PBS-subsidised initial therapy with this drug; AND</p> <p>Patient must demonstrate a clinically meaningful response to the initial treatment; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient&apos;s family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit.</p><p align=""justify"">Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use.</p> <p align=""justify"">Re-assessments for a clinically meaningful response are to be undertaken and documented every six months.</p><p align=""justify"">Clinically meaningful response to treatment is demonstrated in the following areas: </p><p align=""justify"">Patient&apos;s quality of life including but not limited to level of independence and happiness; </p><p align=""justify"">Patient&apos;s cognitive function including but not limited to memory, recognition and interest in environment; </p><p align=""justify"">Patient&apos;s behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour. </p>","N","N","N","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13937_13940_R","Initial","AUTHORITY_REQUIRED","13940","13937","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderately severe Alzheimer disease</p><br/><p>Initial</p><br/><p>Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND</p> <p>The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below. </p><p align=""justify"">Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs. </p><p align=""justify"">Patients who qualify under this criterion are from 1 or more of the following groups:</p><p align=""justify"">(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;</p><p align=""justify"">(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;</p><p align=""justify"">(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;</p><p align=""justify"">(4) Intellectual (developmental or acquired) disability, eg Down&apos;s syndrome;</p><p align=""justify"">(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;</p><p align=""justify"">(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.</p> <p align=""justify"">Up to a maximum of 6 months&apos; initial therapy will be authorised for this drug, for this strength under this treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderately severe Alzheimer disease</p><br/><p>Initial</p><br/><p>Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND</p> <p>The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below. </p><p align=""justify"">Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs. </p><p align=""justify"">Patients who qualify under this criterion are from 1 or more of the following groups:</p><p align=""justify"">(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;</p><p align=""justify"">(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;</p><p align=""justify"">(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;</p><p align=""justify"">(4) Intellectual (developmental or acquired) disability, eg Down&apos;s syndrome;</p><p align=""justify"">(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;</p><p align=""justify"">(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.</p> <p align=""justify"">Up to a maximum of 6 months&apos; initial therapy will be authorised for this drug, for this strength under this treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13939_13941_R","Initial","AUTHORITY_REQUIRED","13941","13939","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderately severe Alzheimer disease</p><br/><p>Initial</p><br/><p>Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more; AND</p> <p>The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified.</p> <p align=""justify"">Up to a maximum of 6 months&apos; initial therapy will be authorised for this drug, for this strength under this treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderately severe Alzheimer disease</p><br/><p>Initial</p><br/><p>Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more; AND</p> <p>The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified.</p> <p align=""justify"">Up to a maximum of 6 months&apos; initial therapy will be authorised for this drug, for this strength under this treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13939_C","null","null","null","null","null","<p>This drug should not be used during pregnancy as it may result in feminisation of the male foetus.</p>","N","Y","N","null","null","N","2015-10-01","N","4708"
"13942_13967_R","null","STREAMLINED","13967","13942","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Alcohol dependence</p><br/><p>The treatment must be part of a comprehensive treatment program with the goal of maintaining abstinence/controlled consumption.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Alcohol dependence</p><br/><p>The treatment must be part of a comprehensive treatment program with the goal of maintaining abstinence/controlled consumption.</p>","N","N","N","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13951_13950_R","Initial PBS-subsidised treatment for patients without T315I mutation","AUTHORITY_REQUIRED","13950","13951","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial PBS-subsidised treatment for patients without T315I mutation</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The condition must not be in the blast phase; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must have failed an adequate trial of at least two tyrosine kinase inhibitors; or</p> <p>Patient must have experienced intolerance, not failure to respond, to at least two tyrosine kinase inhibitors; or</p> <p>Patient must have failed an adequate trial of at least one tyrosine kinase inhibitor with intolerance to at least another tyrosine kinase inhibitor.</p> <p align=""justify"">Failure of an adequate trial of a tyrosine kinase inhibitor is defined as:</p><p align=""justify"">1. Lack of response defined as either:</p><p align=""justify"">(i) failure to achieve a haematological response after a minimum of 3 months therapy; or</p><p align=""justify"">(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive (Ph+) cells; or</p><p align=""justify"">(iii) failure to achieve or maintain a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy; OR</p><p align=""justify"">2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph+ cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy; OR</p><p align=""justify"">3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor (TKI) therapy; OR</p><p align=""justify"">4. Development of accelerated phase in a patient previously prescribed a TKI inhibitor for any phase of chronic myeloid leukaemia; OR</p><p align=""justify"">5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during TKI therapy in patients with accelerated phase chronic myeloid leukaemia.</p> <p/><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p/><p align=""justify"">2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or </p><p/><p align=""justify"">3. Peripheral basophils greater than or equal to 20%; or</p><p/><p align=""justify"">4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or </p><p/><p align=""justify"">5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial PBS-subsidised treatment for patients without T315I mutation</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The condition must not be in the blast phase; AND</p> <p>The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must have failed an adequate trial of at least two tyrosine kinase inhibitors; or</p> <p>Patient must have experienced intolerance, not failure to respond, to at least two tyrosine kinase inhibitors; or</p> <p>Patient must have failed an adequate trial of at least one tyrosine kinase inhibitor with intolerance to at least another tyrosine kinase inhibitor.</p> <p align=""justify"">Failure of an adequate trial of a tyrosine kinase inhibitor is defined as:</p><p align=""justify"">1. Lack of response defined as either:</p><p align=""justify"">(i) failure to achieve a haematological response after a minimum of 3 months therapy; or</p><p align=""justify"">(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive (Ph+) cells; or</p><p align=""justify"">(iii) failure to achieve or maintain a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy; OR</p><p align=""justify"">2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph+ cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy; OR</p><p align=""justify"">3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor (TKI) therapy; OR</p><p align=""justify"">4. Development of accelerated phase in a patient previously prescribed a TKI inhibitor for any phase of chronic myeloid leukaemia; OR</p><p align=""justify"">5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during TKI therapy in patients with accelerated phase chronic myeloid leukaemia.</p> <p/><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p/><p align=""justify"">2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or </p><p/><p align=""justify"">3. Peripheral basophils greater than or equal to 20%; or</p><p/><p align=""justify"">4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or </p><p/><p align=""justify"">5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).</p><p/> <p align=""justify"">Tyrosine Kinase Inhibitors (TKI) are defined as either (i) imatinib, (ii) dasatinib, (iii) nilotinib</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p> <p align=""justify"">Patients are eligible for PBS-subsidised treatment with only one TKI agent at any one time and must not be receiving concomitant interferon alfa therapy. Eligible patients may only swap between TKI agents if they have not failed prior PBS-subsidised treatment with that agent</p>","N","N","Y","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13957_13958_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","13958","13957","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>The treatment must have been prescribed most recently through the Continuing treatment phase in a quantity which did not seek the full number available in regards to any of: (i) the quantity per dispensing, (ii) repeat prescriptions; AND</p> <p>The treatment must provide no more than the balance of 24 weeks treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>The treatment must have been prescribed most recently through the Continuing treatment phase in a quantity which did not seek the full number available in regards to any of: (i) the quantity per dispensing, (ii) repeat prescriptions; AND</p> <p>The treatment must provide no more than the balance of 24 weeks treatment.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13959_13959_R","Dose modification","AUTHORITY_REQUIRED","13959","13959","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Dose modification</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must be undergoing existing PBS-subsidised treatment with this therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Dose modification</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must be undergoing existing PBS-subsidised treatment with this therapy.</p> <p align=""justify"">Any further authority applications occurring immediately after access through this dose modification listing are not to occur through any of the following Treatment phase listings: (i) Balance of Supply, (ii) Initial Treatment.</p> <p align=""justify""><b>Dose modification</b></p><p align=""justify"">Where the drug&apos;s Product Information indicates variable dosing regimens based on the individual&apos;s response/tolerance, apply under this listing to continue treatment with the new strength. Mark any remaining repeat prescriptions for the discontinued strength with the word &apos;cancelled&apos;. This treatment phase listing recognises that a patient&apos;s optimal dose may not always be immediately apparent at the time of treatment initiation and therefore does not require confirmation of an objective, adequate response to the preceding supply of drug.</p>","N","N","N","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13960_11976_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","11976","13960","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13963_7979_R","null","STREAMLINED","7979","13963","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.</p> <p align=""justify"">Patient must be aged 18 years or older.</p> <p align=""justify"">Budesonide/formoterol fumarate dihydrate powder for inhalation 400/12 microgram strength inhalers are not recommended nor PBS-subsidised for use as &apos;maintenance and reliever&apos; therapy.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13964_13936_R","Initial","AUTHORITY_REQUIRED","13936","13964","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderately severe Alzheimer disease</p><br/><p>Initial</p><br/><p>Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND</p> <p>The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">A patient who is unable to register a score of 10 to 14 for reasons other than their Alzheimer disease, as specified below. </p><p align=""justify"">Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs. </p><p align=""justify"">Patients who qualify under this criterion are from 1 or more of the following groups:</p><p align=""justify"">(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;</p><p align=""justify"">(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;</p><p align=""justify"">(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;</p><p align=""justify"">(4) Intellectual (developmental or acquired) disability, eg Down&apos;s syndrome;</p><p align=""justify"">(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;</p><p align=""justify"">(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.</p> <p align=""justify"">Up to a maximum of 6 months&apos; initial therapy will be authorised for this drug, for this strength under this treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderately severe Alzheimer disease</p><br/><p>Initial</p><br/><p>Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND</p> <p>The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">A patient who is unable to register a score of 10 to 14 for reasons other than their Alzheimer disease, as specified below. </p><p align=""justify"">Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs. </p><p align=""justify"">Patients who qualify under this criterion are from 1 or more of the following groups:</p><p align=""justify"">(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;</p><p align=""justify"">(2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;</p><p align=""justify"">(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test;</p><p align=""justify"">(4) Intellectual (developmental or acquired) disability, eg Down&apos;s syndrome;</p><p align=""justify"">(5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test;</p><p align=""justify"">(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.</p> <p align=""justify"">Up to a maximum of 6 months&apos; initial therapy will be authorised for this drug, for this strength under this treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13965_14000_R","Initial","AUTHORITY_REQUIRED","14000","13965","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderately severe Alzheimer disease</p><br/><p>Initial</p><br/><p>Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14; AND</p> <p>The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">The authority application must include the result of the baseline MMSE or SMMSE of 10 to 14.</p> <p align=""justify"">Up to a maximum of 6 months&apos; initial therapy will be authorised for this drug, for this strength under this treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderately severe Alzheimer disease</p><br/><p>Initial</p><br/><p>Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14; AND</p> <p>The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">The authority application must include the result of the baseline MMSE or SMMSE of 10 to 14.</p> <p align=""justify"">Up to a maximum of 6 months&apos; initial therapy will be authorised for this drug, for this strength under this treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13975_N","null","null","null","null","null","<p align=""justify"">For copies of the ACQ please contact Novartis Medical Information on 1800 671 203 or medinfo.phauno@novartis.com</p>","Y","N","N","null","null","N","2015-05-01","N","4708"
"13978_N","null","null","null","null","null","<p>Fentanyl transdermal patches are not recommended in opioid naive patients with non-cancer pain because of a high incidence of adverse events in these patients. Patients with cancer pain may be initiated on the lowest strength patch (12 micrograms per hour).</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"13982_14002_R","Continuing treatment","AUTHORITY_REQUIRED","14002","13982","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13983_13946_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","13946","13983","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13989_13999_R","Initial treatment - Initial 1 (new patient - untreated with biological medicine)","AUTHORITY_REQUIRED","13999","13989","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient - untreated with biological medicine)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient - untreated with biological medicine)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-05-01","Y","4708"
"13994_14017_R","Dose escalation occurring at initial treatment or re-initiation of treatment","STREAMLINED","14017","13994","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Dose escalation occurring at initial treatment or re-initiation of treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Dose escalation occurring at initial treatment or re-initiation of treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p>","N","N","N","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13995_13995_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","13995","13995","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 9 and 17 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 9 and 17 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-05-01","Y","4708"
"13996_13949_R","Continuing treatment","STREAMLINED","13949","13996","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"13997_13977_R","Initial treatment","AUTHORITY_REQUIRED","13977","13997","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Achondroplasia</p><br/><p>Initial treatment</p><br/><p>Patient must have a diagnosis of achondroplasia, confirmed by appropriate genetic testing; AND</p> <p>Patient must not have evidence of growth plate closure demonstrated by at least one of the following: i) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 6 months of this application if puberty has commenced; ii) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 2 years of commencing treatment if puberty has not commenced; iii) an annual growth velocity of greater than 1.5 cm/year as assessed over a period of at least 6 months; AND</p> <p>Must be treated by a medical specialist, experienced in the management of achondroplasia; or</p> <p>Must be treated by a paediatrician in consultation with a medical specialist experienced in the management of achondroplasia.</p> <p align=""justify"">Appropriate genetic testing constitutes testing for FGFR3 gene mutation.</p> <p align=""justify"">In patients where puberty has not commenced, radiographic evidence that epiphyses have not closed must be obtained within 2 years of commencing treatment with vosoritide. X-rays and dates (date commenced treatment and date of X-ray) must be documented in the patient&apos;s medical records.</p><p align=""justify"">Additional radiographic evidence is not required until patient has begun puberty.</p><p align=""justify"">In patients where puberty has commenced, radiographic evidence that epiphyses have not closed must be obtained within 6 months of completing an authority application for vosoritide. X-ray and date taken must be documented in the patient&apos;s medical records.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Achondroplasia</p><br/><p>Initial treatment</p><br/><p>Patient must have a diagnosis of achondroplasia, confirmed by appropriate genetic testing; AND</p> <p>Patient must not have evidence of growth plate closure demonstrated by at least one of the following: i) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 6 months of this application if puberty has commenced; ii) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 2 years of commencing treatment if puberty has not commenced; iii) an annual growth velocity of greater than 1.5 cm/year as assessed over a period of at least 6 months; AND</p> <p>Must be treated by a medical specialist, experienced in the management of achondroplasia; or</p> <p>Must be treated by a paediatrician in consultation with a medical specialist experienced in the management of achondroplasia.</p> <p align=""justify"">Appropriate genetic testing constitutes testing for FGFR3 gene mutation.</p> <p align=""justify"">In patients where puberty has not commenced, radiographic evidence that epiphyses have not closed must be obtained within 2 years of commencing treatment with vosoritide. X-rays and dates (date commenced treatment and date of X-ray) must be documented in the patient&apos;s medical records.</p><p align=""justify"">Additional radiographic evidence is not required until patient has begun puberty.</p><p align=""justify"">In patients where puberty has commenced, radiographic evidence that epiphyses have not closed must be obtained within 6 months of completing an authority application for vosoritide. X-ray and date taken must be documented in the patient&apos;s medical records.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2023-05-01","N","4708"
"14003_14003_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","14003","14003","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 9 and 17 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 9 and 17 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-05-01","Y","4708"
"14004_14004_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","14004","14004","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 9 and 17 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 9 and 17 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-05-01","Y","4708"
"14005_14005_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","14005","14005","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"14012_14014_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","14014","14012","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition if relevant; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition if relevant; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-05-01","Y","4708"
"14013_13990_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","13990","14013","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-05-01","Y","4708"
"14019_13966_R","Continuing","STREAMLINED","13966","14019","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderately severe Alzheimer disease</p><br/><p>Continuing</p><br/><p>Patient must have received six months of sole PBS-subsidised initial therapy with this drug; AND</p> <p>Patient must demonstrate a clinically meaningful response to the initial treatment; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient&apos;s family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit.</p><p align=""justify"">Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use.</p> <p align=""justify"">Re-assessments for a clinically meaningful response are to be undertaken and documented every six months.</p><p align=""justify"">Clinically meaningful response to treatment is demonstrated in the following areas: </p><p align=""justify"">Patient&apos;s quality of life including but not limited to level of independence and happiness; </p><p align=""justify"">Patient&apos;s cognitive function including but not limited to memory, recognition and interest in environment; </p><p align=""justify"">Patient&apos;s behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderately severe Alzheimer disease</p><br/><p>Continuing</p><br/><p>Patient must have received six months of sole PBS-subsidised initial therapy with this drug; AND</p> <p>Patient must demonstrate a clinically meaningful response to the initial treatment; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient&apos;s family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit.</p><p align=""justify"">Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use.</p> <p align=""justify"">Re-assessments for a clinically meaningful response are to be undertaken and documented every six months.</p><p align=""justify"">Clinically meaningful response to treatment is demonstrated in the following areas: </p><p align=""justify"">Patient&apos;s quality of life including but not limited to level of independence and happiness; </p><p align=""justify"">Patient&apos;s cognitive function including but not limited to memory, recognition and interest in environment; </p><p align=""justify"">Patient&apos;s behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour. </p>","N","N","N","IMMEDIATE","ALL","N","2023-05-01","N","4708"
"14027_14027_R","Initial treatment","STREAMLINED","14027","14027","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Initial treatment</p><br/><p>Patient must have received prior treatment with platinum-based chemotherapy; AND</p> <p>The condition must be untreated with each of: (i) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (ii) tyrosine kinase inhibitor therapy; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Initial treatment</p><br/><p>Patient must have received prior treatment with platinum-based chemotherapy; AND</p> <p>The condition must be untreated with each of: (i) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (ii) tyrosine kinase inhibitor therapy; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p> <p align=""justify"">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p>","N","N","N","IMMEDIATE","ALL","N","2023-06-01","N","4708"
"14029_14024_R","Initial treatment - Dose requirement of 100 mg per week","AUTHORITY_REQUIRED","14024","14029","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Initial treatment - Dose requirement of 100 mg per week</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; or</p> <p>Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must not have previously received this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Initial treatment - Dose requirement of 100 mg per week</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; or</p> <p>Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must not have previously received this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy</p>","N","N","N","IMMEDIATE","ALL","N","2023-06-01","N","4708"
"14030_14039_R","Initial treatment - Dose requirement of 160 mg per week","AUTHORITY_REQUIRED","14039","14030","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Initial treatment - Dose requirement of 160 mg per week</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must not have previously received this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Initial treatment - Dose requirement of 160 mg per week</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must not have previously received this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy</p>","N","N","N","IMMEDIATE","ALL","N","2023-06-01","N","4708"
"14033_14040_R","null","RESTRICTED","14040","14033","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>The treatment must be as an aid to achieving abstinence from smoking; AND</p> <p>The treatment must not be a PBS-benefit with other non-nicotine drugs that are PBS indicated for smoking cessation; AND</p> <p>Patient must have indicated they are ready to cease smoking; AND</p> <p>Patient must not receive more than 2 x 12-week PBS-subsidised treatment courses per 12 month period; AND</p> <p>Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program or is about to enter such a program at the time PBS-subsidised treatment is initiated.</p> <p align=""justify"">Details of the support and counselling program must be documented in the patient&apos;s medical records at the time treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>The treatment must be as an aid to achieving abstinence from smoking; AND</p> <p>The treatment must not be a PBS-benefit with other non-nicotine drugs that are PBS indicated for smoking cessation; AND</p> <p>Patient must have indicated they are ready to cease smoking; AND</p> <p>Patient must not receive more than 2 x 12-week PBS-subsidised treatment courses per 12 month period; AND</p> <p>Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program or is about to enter such a program at the time PBS-subsidised treatment is initiated.</p> <p align=""justify"">Details of the support and counselling program must be documented in the patient&apos;s medical records at the time treatment is initiated.</p>","N","N","N","IMMEDIATE","ALL","N","2023-06-01","N","4708"
"14035_14021_R","Initial treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week","AUTHORITY_REQUIRED","14021","14035","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Initial treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; or</p> <p>Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must not have previously received this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient&apos;s medical records.</p><p align=""justify"">Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient&apos;s medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Initial treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; or</p> <p>Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must not have previously received this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient&apos;s medical records.</p><p align=""justify"">Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient&apos;s medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy</p>","N","N","N","IMMEDIATE","ALL","N","2023-06-01","N","4708"
"14036_14045_R","Continuing treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week","AUTHORITY_REQUIRED","14045","14036","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; or</p> <p>Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; or</p> <p>Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2023-06-01","N","4708"
"14038_14023_R","Continuing treatment - Dose requirement of 100 mg per week","AUTHORITY_REQUIRED","14023","14038","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment - Dose requirement of 100 mg per week</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; or</p> <p>Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment - Dose requirement of 100 mg per week</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; or</p> <p>Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2023-06-01","N","4708"
"14044_14044_R","Continuing treatment","STREAMLINED","14044","14044","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2023-06-01","N","4708"
"14046_14031_R","Continuing treatment - Dose requirement of 160 mg per week","AUTHORITY_REQUIRED","14031","14046","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment - Dose requirement of 160 mg per week</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment - Dose requirement of 160 mg per week</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2023-06-01","N","4708"
"14049_14026_R","Initial treatment for up to the first 180 days of treatment","AUTHORITY_REQUIRED","14026","14049","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe dry eye disease with keratitis</p><br/><p>Initial treatment for up to the first 180 days of treatment</p><br/><p>Patient must have a corneal fluorescein staining (CFS) grade of 4 at treatment initiation, using at least one of: (i) the Oxford scale, (ii) the modified Oxford scale, (iii) an equivalent scale to the Oxford scale as determined by the prescriber; AND</p> <p>Patient must have an ocular surface disease index (OSDI) score of at least 23 at treatment initiation; AND</p> <p>The condition must be inadequately controlled by monotherapy with a preservative free artificial tears substitute; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be undergoing simultaneous treatment with a preservative free artificial tears substitute; AND</p> <p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; or</p> <p>Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines; AND</p> <p>Patient must not be undergoing treatment with this drug under this treatment phase beyond day 180 of treatment; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Prescribing instruction:</p><p align=""justify"">State in the first authority application for this drug, for the purpose of having a baseline measurement to assess response to treatment under the Continuing treatment listing, each of: (i) the qualifying corneal fluorescein staining grade (a numerical value no less than 4), (ii) the qualifying ocular surface disease index score (a numerical value no less than 23).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe dry eye disease with keratitis</p><br/><p>Initial treatment for up to the first 180 days of treatment</p><br/><p>Patient must have a corneal fluorescein staining (CFS) grade of 4 at treatment initiation, using at least one of: (i) the Oxford scale, (ii) the modified Oxford scale, (iii) an equivalent scale to the Oxford scale as determined by the prescriber; AND</p> <p>Patient must have an ocular surface disease index (OSDI) score of at least 23 at treatment initiation; AND</p> <p>The condition must be inadequately controlled by monotherapy with a preservative free artificial tears substitute; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be undergoing simultaneous treatment with a preservative free artificial tears substitute; AND</p> <p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; or</p> <p>Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines; AND</p> <p>Patient must not be undergoing treatment with this drug under this treatment phase beyond day 180 of treatment; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Prescribing instruction:</p><p align=""justify"">State in the first authority application for this drug, for the purpose of having a baseline measurement to assess response to treatment under the Continuing treatment listing, each of: (i) the qualifying corneal fluorescein staining grade (a numerical value no less than 4), (ii) the qualifying ocular surface disease index score (a numerical value no less than 23).</p> <p align=""justify"">The Oxford scale, modified Oxford scale and Ocular Surface Disease Index (OSDI) were relied upon in the submission supporting initial PBS listing.</p><p align=""justify"">The Oxford scale uses a chart system consisting of a series of panels, labelled A to E in order of increasing severity. In each chart, staining is represented by dots. To grade staining, comparisons are made between the panels and the appearance of staining on the exposed interpalpebral conjunctiva and cornea of the patient. The details of the chart are presented in Figure 1 and, in a simplified form in Figure 4 (where the criteria, dot count and log columns are not displayed), in the following literature article: Bron A, Evans V, Smith, J. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003;22(7):640-650.</p><p align=""justify"">The modified Oxford scale is as above, but with the first grade depiction (Grade 0), termed &apos;Grade 0.5&apos;.</p><p align=""justify"">A list of equivalent scales to the Oxford scale is not provided. Prescribers should be satisfied that a scale other than the Oxford scale, if used, is equivalent to the Oxford scale.</p><p align=""justify"">The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire created by the Outcomes Research Group at Allergan Inc, Irvine, CA, USA, to assess dry eye symptoms and the effects on vision-related function.</p><p align=""justify"">The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to &apos;none of the time&apos; and 4 corresponding to &apos;all of the time&apos;. A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.</p><p align=""justify"">The OSDI questionnaire asks the following:</p><p align=""justify"">Presence of ocular symptoms - Have you experienced any of the following during the last week?</p><p align=""justify"">1. Eyes that are sensitive to light</p><p align=""justify"">2. Eyes that feel gritty</p><p align=""justify"">3. Painful or sore eyes</p><p align=""justify"">4. Blurred vision</p><p align=""justify"">5. Poor vision</p><p align=""justify"">Impact on daily activities - Have you had problems with your eyes limited you in performing any of the following during the last week?</p><p align=""justify"">1. Reading</p><p align=""justify"">2. Driving at night</p><p align=""justify"">3. Working with a computer or bank machine (ATM)</p><p align=""justify"">4. Watching TV</p><p align=""justify"">Environmental factors - Have your eyes felt uncomfortable in any of the following situations during the last week?</p><p align=""justify"">1. Windy conditions</p><p align=""justify"">2. Places or areas with low humidity (very dry)</p><p align=""justify"">3. Areas that are airconditioned</p><p align=""justify"">Rate responses on a scale of 0 to 4; 0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, and 4 = all of the time.</p><p align=""justify"">Further information on this index is in the following literature article: Walt J, Rowe M, Stern K. Evaluating the functional impact of dry eye: the Ocular Surface Disease Index. Drug Information Journal. 1997;31:1436</p><p align=""justify"">The &apos;Dry Eye OSDI &apos;Questionnaire&apos; app developed by Allergan Inc is available to download for iPhone.</p> <p align=""justify"">If the maximum number of repeats stated in this listing is not requested in this application, further supplies can be obtained through this treatment phase listing to continue treatment for up to the first 180 days of treatment, but the OSDI score and CFS grade need not be re-stated. Alternatively, treatment may be continued under the &apos;Continuing treatment&apos; phase listing, provided the patient meets all eligibility criteria specified in that treatment phase listing.</p>","N","N","N","IMMEDIATE","ALL","N","2023-06-01","N","4708"
"14050_14032_R","Continuing treatment","AUTHORITY_REQUIRED","14032","14050","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe dry eye disease with keratitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must have improved to an extent that corneal fluorescein staining, using the same scale used at the time of the first authority application, shows an improvement (reduction) by at least 3 grades from baseline (the grade stated in the first authority application) - the improvement need only be demonstrated by staining once only with the first Continuing treatment authority application; AND</p> <p>The condition must have improved to an extent that the patient''s ocular surface disease index score at the time of this authority application, has improved (reduced) by at least 30% compared to the value stated in the first authority application (i.e. baseline); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; or</p> <p>Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines.</p> <p align=""justify"">Prescribing instructions:</p><p align=""justify"">State in the first continuing treatment authority application for this drug:</p><p align=""justify"">(i) an improved corneal fluorescein staining grade (a numerical value that has improved by 3 grades from that provided in the first Initial 1 treatment authority application).</p><p align=""justify"">State in all continuing treatment authority applications:</p><p align=""justify"">(ii) the ocular surface disease index score at the time of this authority application (a numerical value that is at least 30% lower than that stated in the first Initial 1 treatment authority application).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe dry eye disease with keratitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must have improved to an extent that corneal fluorescein staining, using the same scale used at the time of the first authority application, shows an improvement (reduction) by at least 3 grades from baseline (the grade stated in the first authority application) - the improvement need only be demonstrated by staining once only with the first Continuing treatment authority application; AND</p> <p>The condition must have improved to an extent that the patient''s ocular surface disease index score at the time of this authority application, has improved (reduced) by at least 30% compared to the value stated in the first authority application (i.e. baseline); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; or</p> <p>Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines.</p> <p align=""justify"">Prescribing instructions:</p><p align=""justify"">State in the first continuing treatment authority application for this drug:</p><p align=""justify"">(i) an improved corneal fluorescein staining grade (a numerical value that has improved by 3 grades from that provided in the first Initial 1 treatment authority application).</p><p align=""justify"">State in all continuing treatment authority applications:</p><p align=""justify"">(ii) the ocular surface disease index score at the time of this authority application (a numerical value that is at least 30% lower than that stated in the first Initial 1 treatment authority application).</p>","N","N","N","IMMEDIATE","ALL","N","2023-06-01","N","4708"
"14051_14149_R","Balance of supply or change of therapy","AUTHORITY_REQUIRED","14149","14051","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Balance of supply or change of therapy</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; or</p> <p>Patient must be changing therapy from eltrombopag or avatrombopag to this drug for this condition; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.</p> <p align=""justify"">Patients receiving treatment with eltrombopag or avatrombopag may change to romiplostim under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Balance of supply or change of therapy</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; or</p> <p>Patient must be changing therapy from eltrombopag or avatrombopag to this drug for this condition; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.</p> <p align=""justify"">Patients receiving treatment with eltrombopag or avatrombopag may change to romiplostim under this restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14054_14054_R","Second or Subsequent Continuing treatment","AUTHORITY_REQUIRED","14054","14054","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Second or Subsequent Continuing treatment</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND</p> <p>Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Second or Subsequent Continuing treatment</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND</p> <p>Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14059_12120_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supply","AUTHORITY_REQUIRED","12120","14059","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supply</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supply</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14084_14084_R","Continuing treatment in a patient weighing less than 30 kg","STREAMLINED","14084","14084","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Continuing treatment in a patient weighing less than 30 kg</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Continuing treatment in a patient weighing less than 30 kg</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14086_14148_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","14148","14086","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or</p> <p>Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:</p><p align=""justify"">(a) an active joint count of at least 2 active joints; and</p><p align=""justify"">(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or</p><p align=""justify"">(c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).</p><p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month&apos;s supply). A separate authority approval is required for each strength requested.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or</p> <p>Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:</p><p align=""justify"">(a) an active joint count of at least 2 active joints; and</p><p align=""justify"">(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or</p><p align=""justify"">(c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).</p><p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month&apos;s supply). A separate authority approval is required for each strength requested.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14087_14182_R","Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing less than 30 kg)","AUTHORITY_REQUIRED","14182","14087","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing less than 30 kg)</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing less than 30 kg)</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14089_14147_R","Initial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months in a patient weighing at least 30 kg)","AUTHORITY_REQUIRED","14147","14089","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months in a patient weighing at least 30 kg)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND</p> <p>Patient must have polyarticular course disease and the condition must have at least one of: (a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); or</p> <p>Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months in a patient weighing at least 30 kg)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND</p> <p>Patient must have polyarticular course disease and the condition must have at least one of: (a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); or</p> <p>Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14090_14088_R","Continuing treatment in a patient weighing at least 30 kg","STREAMLINED","14088","14090","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Continuing treatment in a patient weighing at least 30 kg</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) baseline and current pathology reports detailing C-reactive protein (CRP) levels; and</p><p align=""justify"">(b) baseline and current pathology reports detailing platelet count.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Continuing treatment in a patient weighing at least 30 kg</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) baseline and current pathology reports detailing C-reactive protein (CRP) levels; and</p><p align=""justify"">(b) baseline and current pathology reports detailing platelet count.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14096_14096_R","null","RESTRICTED","14096","14096","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infertility indications other than that of Assisted Reproductive Technology</p><br/><p>Patient must not be undergoing treatment with medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug through another PBS program listing; AND</p> <p>Must be treated by an obstetrician/gynaecologist; or</p> <p>Must be treated by a specialist in reproductive endocrinology/infertility; or</p> <p>Must be treated by a urogynaecologist; or</p> <p>Must be treated by an endocrinologist; or</p> <p>Must be treated by a urologist.</p> <p align=""justify"">The PBS prescription, whether it is to initiate or continue treatment, must be made out under the specialist&apos;s prescriber number.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infertility indications other than that of Assisted Reproductive Technology</p><br/><p>Patient must not be undergoing treatment with medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug through another PBS program listing; AND</p> <p>Must be treated by an obstetrician/gynaecologist; or</p> <p>Must be treated by a specialist in reproductive endocrinology/infertility; or</p> <p>Must be treated by a urogynaecologist; or</p> <p>Must be treated by an endocrinologist; or</p> <p>Must be treated by a urologist.</p> <p align=""justify"">The PBS prescription, whether it is to initiate or continue treatment, must be made out under the specialist&apos;s prescriber number.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14097_14097_R","null","STREAMLINED","14097","14097","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic kidney disease with Type 2 diabetes</p><br/><p>Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of: (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug; AND</p> <p>Patient must not have known significant non-diabetic renal disease, prior to initiating treatment with this drug; AND</p> <p>Patient must have an estimated glomerular filtration rate of 25 mL/min/1.73 m2 or greater, prior to initiating treatment with this drug; AND</p> <p>Patient must have a urinary albumin-to-creatinine ratio of 200 mg/g (22.6 mg/mmol) or greater, prior to initiating treatment with this drug; AND</p> <p>Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant; AND</p> <p>Patient must be stabilised, for at least 4 weeks, on either: (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug; AND</p> <p>The treatment must be in combination with an SGLT2i unless medically contraindicated or intolerant; AND</p> <p>Patient must not be receiving treatment with another selective nonsteroidal mineralocorticoid receptor antagonist, a renin inhibitor or a potassium-sparing diuretic; AND</p> <p>Patient must not have established heart failure with reduced ejection fraction with an indication for treatment with a mineralocorticoid receptor antagonist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic kidney disease with Type 2 diabetes</p><br/><p>Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of: (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug; AND</p> <p>Patient must not have known significant non-diabetic renal disease, prior to initiating treatment with this drug; AND</p> <p>Patient must have an estimated glomerular filtration rate of 25 mL/min/1.73 m2 or greater, prior to initiating treatment with this drug; AND</p> <p>Patient must have a urinary albumin-to-creatinine ratio of 200 mg/g (22.6 mg/mmol) or greater, prior to initiating treatment with this drug; AND</p> <p>Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant; AND</p> <p>Patient must be stabilised, for at least 4 weeks, on either: (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug; AND</p> <p>The treatment must be in combination with an SGLT2i unless medically contraindicated or intolerant; AND</p> <p>Patient must not be receiving treatment with another selective nonsteroidal mineralocorticoid receptor antagonist, a renin inhibitor or a potassium-sparing diuretic; AND</p> <p>Patient must not have established heart failure with reduced ejection fraction with an indication for treatment with a mineralocorticoid receptor antagonist.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14100_14129_R","First Continuing treatment or Re-initiation of interrupted continuing treatment","AUTHORITY_REQUIRED","14129","14100","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>First Continuing treatment or Re-initiation of interrupted continuing treatment</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have changed treatment from either romiplostim or avatrombopag to this drug under the Balance of Supply/Change of therapy restriction and demonstrated a sustained response; or</p> <p>Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.</p> <p align=""justify"">The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>First Continuing treatment or Re-initiation of interrupted continuing treatment</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have changed treatment from either romiplostim or avatrombopag to this drug under the Balance of Supply/Change of therapy restriction and demonstrated a sustained response; or</p> <p>Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.</p> <p align=""justify"">The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14102_9477_R","Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supply","AUTHORITY_REQUIRED","9477","14102","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supply</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 16 or 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 or 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 or 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions for patients 30 kg or over; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions for patients under 30 kg.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) - balance of supply</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 16 or 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 or 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 or 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions for patients 30 kg or over; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions for patients under 30 kg.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14114_10570_R","Balance of supply for Initial treatment - Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months)","AUTHORITY_REQUIRED","10570","14114","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Balance of supply for Initial treatment - Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months)</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under Initial 3 (recommencement of treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Balance of supply for Initial treatment - Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months)</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under Initial 3 (recommencement of treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14117_14093_R","Continuing treatment","STREAMLINED","14093","14117","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month&apos;s supply). A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month&apos;s supply). A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14118_14080_R","Initial treatment - Initial 1 (new patient weighing at least 30 kg)","AUTHORITY_REQUIRED","14080","14118","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient weighing at least 30 kg)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or</p> <p>Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:</p><p align=""justify"">(a) an active joint count of at least 2 active joints; and</p><p align=""justify"">(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or</p><p align=""justify"">(c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).</p><p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis;</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment; and</p><p align=""justify"">(c) the pathology reports detailing CRP and platelet count where appropriate.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient weighing at least 30 kg)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or</p> <p>Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:</p><p align=""justify"">(a) an active joint count of at least 2 active joints; and</p><p align=""justify"">(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or</p><p align=""justify"">(c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).</p><p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis;</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment; and</p><p align=""justify"">(c) the pathology reports detailing CRP and platelet count where appropriate.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14120_14085_R","Initial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months)","AUTHORITY_REQUIRED","14085","14120","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND</p> <p>Patient must have polyarticular course disease and the condition must have at least one of: (a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); or</p> <p>Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month&apos;s supply). A separate authority approval is required for each strength requested.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND</p> <p>Patient must have polyarticular course disease and the condition must have at least one of: (a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); or</p> <p>Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month&apos;s supply). A separate authority approval is required for each strength requested.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14122_10560_R","Balance of supply for Initial treatment - Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months) - in a patient of any weight being administered a subcutaneous form of this biological medicine","AUTHORITY_REQUIRED","10560","14122","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Balance of supply for Initial treatment - Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months) - in a patient of any weight being administered a subcutaneous form of this biological medicine</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under Initial 3 (recommencement of treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Balance of supply for Initial treatment - Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months) - in a patient of any weight being administered a subcutaneous form of this biological medicine</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under Initial 3 (recommencement of treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14125_14099_R","First Continuing treatment or Re-initiation of interrupted continuing treatment","AUTHORITY_REQUIRED","14099","14125","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>First Continuing treatment or Re-initiation of interrupted continuing treatment</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have changed treatment from either eltrombopag or avatrombopag to this drug under the Balance of Supply/Change of therapy restriction and demonstrated a sustained response; or</p> <p>Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.</p> <p align=""justify"">The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.</p> <p align=""justify"">Authority approval will not be given for doses higher than 10 micrograms/kg/week</p> <p align=""justify"">The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>First Continuing treatment or Re-initiation of interrupted continuing treatment</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have changed treatment from either eltrombopag or avatrombopag to this drug under the Balance of Supply/Change of therapy restriction and demonstrated a sustained response; or</p> <p>Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.</p> <p align=""justify"">The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.</p> <p align=""justify"">Authority approval will not be given for doses higher than 10 micrograms/kg/week</p> <p align=""justify"">The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14128_14127_R","Balance of supply or change of therapy","AUTHORITY_REQUIRED","14127","14128","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Balance of supply or change of therapy</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; or</p> <p>Patient must be changing therapy from romiplostim or avatrombopag to this drug for this condition; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.</p> <p align=""justify"">Patients receiving treatment with romiplostim or avatrombopag may change to eltrombopag under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Balance of supply or change of therapy</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; or</p> <p>Patient must be changing therapy from romiplostim or avatrombopag to this drug for this condition; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.</p> <p align=""justify"">Patients receiving treatment with romiplostim or avatrombopag may change to eltrombopag under this restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14135_14135_R","Initial treatment","AUTHORITY_REQUIRED","14135","14135","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Rheumatoid arthritis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a consultant physician; AND</p> <p>Patient must be an adult; AND</p> <p>Patient must have active rheumatoid arthritis; AND</p> <p>Patient must have a specific accepted war-caused or service-related disability of refractory rheumatoid arthritis; AND</p> <p>Patient must have a proven raised erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP) level; AND</p> <p>Patient must have proven erosive rheumatoid arthritis without end-stage disease; AND</p> <p>Patient must have failed an adequate trial of methotrexate and 2 other disease modifying anti-rheumatic drugs (such as sulfasalazine, hydroxychloroquine, leflunomide or ciclosporin), unless these drugs were contraindicated or intolerance developed; AND</p> <p>Patient must have no history of active tuberculosis requiring treatment in the last 3 years; AND</p> <p>Patient must have no history of opportunistic infection in the last 2 months; AND</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>The treatment must be for the reduction of signs and symptoms and prevention of structural joint damage; AND</p> <p>Patient must not be pregnant or breastfeeding; AND</p> <p>Patient must be using an effective form of contraception if female and of child-bearing age.</p> <p align=""justify"">Applications for authorisation must be in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed Infliximab (Remicade) RPBS Authority Application - Supporting Information form (contact the VAPAC on 1800 552 580 for a copy of the form).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Rheumatoid arthritis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a consultant physician; AND</p> <p>Patient must be an adult; AND</p> <p>Patient must have active rheumatoid arthritis; AND</p> <p>Patient must have a specific accepted war-caused or service-related disability of refractory rheumatoid arthritis; AND</p> <p>Patient must have a proven raised erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP) level; AND</p> <p>Patient must have proven erosive rheumatoid arthritis without end-stage disease; AND</p> <p>Patient must have failed an adequate trial of methotrexate and 2 other disease modifying anti-rheumatic drugs (such as sulfasalazine, hydroxychloroquine, leflunomide or ciclosporin), unless these drugs were contraindicated or intolerance developed; AND</p> <p>Patient must have no history of active tuberculosis requiring treatment in the last 3 years; AND</p> <p>Patient must have no history of opportunistic infection in the last 2 months; AND</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>The treatment must be for the reduction of signs and symptoms and prevention of structural joint damage; AND</p> <p>Patient must not be pregnant or breastfeeding; AND</p> <p>Patient must be using an effective form of contraception if female and of child-bearing age.</p> <p align=""justify"">Applications for authorisation must be in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed Infliximab (Remicade) RPBS Authority Application - Supporting Information form (contact the VAPAC on 1800 552 580 for a copy of the form).</p>","N","N","N","FULL","ALL","N","2023-07-01","Y","4708"
"14143_14091_R","Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months)","AUTHORITY_REQUIRED","14091","14143","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month&apos;s supply). A separate authority approval is required for each strength requested.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month&apos;s supply). A separate authority approval is required for each strength requested.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14146_14179_R","Continuing treatment","STREAMLINED","14179","14146","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month&apos;s supply). A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month&apos;s supply). A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14151_C","null","null","null","null","null","<p align=""justify"">Visual field defects have been reported with this drug.</p>","N","Y","N","null","null","N","2015-06-01","N","4708"
"14163_14175_R","Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing at least 30 kg)","AUTHORITY_REQUIRED","14175","14163","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing at least 30 kg)</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing at least 30 kg)</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) in a patient with polyarticular course disease:</p><p align=""justify"">(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">(b) in a patient with refractory systemic symptoms:</p><p align=""justify"">(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or</p><p align=""justify"">(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or</p><p align=""justify"">(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.</p><p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14165_14094_R","Initial treatment - Initial 1 (new patient weighing less than 30 kg)","AUTHORITY_REQUIRED","14094","14165","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient weighing less than 30 kg)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or</p> <p>Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:</p><p align=""justify"">(a) an active joint count of at least 2 active joints; and</p><p align=""justify"">(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or</p><p align=""justify"">(c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).</p><p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient weighing less than 30 kg)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or</p> <p>Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:</p><p align=""justify"">(a) an active joint count of at least 2 active joints; and</p><p align=""justify"">(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or</p><p align=""justify"">(c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).</p><p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14169_N","null","null","null","null","null","<p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the accepted toxicities, including severity, which will be accepted for the purposes of exempting a patient from the requirement of treatment with optimised asthma therapy.</p>","Y","N","N","null","null","N","2015-05-01","N","4708"
"14170_C","null","null","null","null","null","<p align=""justify"">Severe cholestatic hepatitis has been reported with this drug. Significant risk factors are age, particularly greater than 55 years, and duration of treatment longer than 14 days.</p>","N","Y","N","null","null","N","2015-06-01","N","4708"
"14172_14180_R","null","STREAMLINED","14180","14172","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The treatment must not be a PBS benefit where this 50 microgram strength is being initiated in a patient over the age of 6.00 years.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The treatment must not be a PBS benefit where this 50 microgram strength is being initiated in a patient over the age of 6.00 years.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14173_9180_R","Continuing treatment","AUTHORITY_REQUIRED","9180","14173","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Active giant cell arteritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed 52 weeks in total including initial and continuing applications.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Active giant cell arteritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed 52 weeks in total including initial and continuing applications.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14176_14124_R","null","STREAMLINED","14124","14176","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug through another PBS program listing.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug through another PBS program listing.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14180_C","null","null","null","null","null","<p align=""justify"">Serum electrolytes should be checked regularly</p>","N","Y","N","null","null","N","2015-06-01","N","4708"
"14181_14121_R","Initial treatment - Initial 3 (recommencement of a new treatment cycle after a break of more than 12 months in a patient weighing less than 30 kg)","AUTHORITY_REQUIRED","14121","14181","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of a new treatment cycle after a break of more than 12 months in a patient weighing less than 30 kg)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND</p> <p>Patient must have polyarticular course disease and the condition must have at least one of: (a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); or</p> <p>Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of a new treatment cycle after a break of more than 12 months in a patient weighing less than 30 kg)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND</p> <p>Patient must have polyarticular course disease and the condition must have at least one of: (a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); or</p> <p>Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active systemic juvenile idiopathic arthritis.</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records where appropriate:</p><p align=""justify"">(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.</p> <p align=""justify"">The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2023-07-01","N","4708"
"14183_14183_R","Continuing treatment","AUTHORITY_REQUIRED","14183","14183","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Rheumatoid arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a consultant physician; AND</p> <p>Patient must have a specific accepted war-caused or service-related disability of refractory rheumatoid arthritis; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug for the treatment of this condition; AND</p> <p>Patient must have demonstrated an improvement in ESR and/or CRP level following the initial 3 dose course of therapy; AND</p> <p>Patient must have achieved an ACR20 (American College of Rheumatology) response by 14 weeks after the commencement of the initial course of therapy; AND</p> <p>The treatment must be in combination with methotrexate.</p> <p align=""justify"">Applications for authorisation must be in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed Infliximab (Remicade) RPBS Authority Application - Supporting Information form (contact the VAPAC on 1800 552 580 for a copy of the form).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Rheumatoid arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a consultant physician; AND</p> <p>Patient must have a specific accepted war-caused or service-related disability of refractory rheumatoid arthritis; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug for the treatment of this condition; AND</p> <p>Patient must have demonstrated an improvement in ESR and/or CRP level following the initial 3 dose course of therapy; AND</p> <p>Patient must have achieved an ACR20 (American College of Rheumatology) response by 14 weeks after the commencement of the initial course of therapy; AND</p> <p>The treatment must be in combination with methotrexate.</p> <p align=""justify"">Applications for authorisation must be in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed Infliximab (Remicade) RPBS Authority Application - Supporting Information form (contact the VAPAC on 1800 552 580 for a copy of the form).</p>","N","N","N","FULL","ALL","N","2023-07-01","Y","4708"
"14193_14217_R","Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","14217","14193","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-08-01","N","4708"
"14197_14197_R","Continuing treatment","STREAMLINED","14197","14197","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2023-08-01","N","4708"
"14203_14195_R","Initial treatment","AUTHORITY_REQUIRED","14195","14203","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Active giant cell arteritis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis; AND</p> <p>Patient must have clinical symptoms of active giant cell arteritis in the absence of any other identifiable cause; AND</p> <p>Patient must have an ESR equal to or greater than 30 mm/hour within the past 6 weeks; or</p> <p>Patient must have a CRP equal to or greater than 10 mg/L within the past 6 weeks; or</p> <p>Patient must have active giant cell arteritis confirmed by positive temporal artery biopsy or imaging; AND</p> <p>Patient must have had a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis; AND</p> <p>Patient must have had temporal artery biopsy revealing features of giant cell arteritis at diagnosis; or</p> <p>Patient must have had evidence of large-vessel vasculitis by magnetic resonance (MR) or computed tomography (CT) angiography or PET/CT at diagnosis; or</p> <p>Patient must have had evidence of positive temporal artery halo sign by ultrasound (US) at diagnosis; AND</p> <p>The treatment must be in combination with a tapering course of corticosteroids; AND</p> <p>The treatment must not exceed 52 weeks in total including initial and continuing applications; AND</p> <p>Patient must be aged 50 years or older.</p> <p align=""justify"">Clinical symptoms of giant cell arteritis at diagnosis include unequivocal cranial symptoms of giant cell arteritis (new onset localized headache, scalp tenderness, temporal artery tenderness or decreased pulsation, ischemia related vision loss, or otherwise unexplained mouth or jaw pain upon mastication); or symptoms of polymyalgia rheumatica, defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS and must include:</p><p align=""justify"">(a) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has active giant cell arteritis including pathology reports outlining the patient&apos;s ESR or CRP levels within the last 6 weeks, or positive temporal artery biopsy or imaging; and</p><p align=""justify"">(b) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has been diagnosed with giant cell arteritis with a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Active giant cell arteritis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis; AND</p> <p>Patient must have clinical symptoms of active giant cell arteritis in the absence of any other identifiable cause; AND</p> <p>Patient must have an ESR equal to or greater than 30 mm/hour within the past 6 weeks; or</p> <p>Patient must have a CRP equal to or greater than 10 mg/L within the past 6 weeks; or</p> <p>Patient must have active giant cell arteritis confirmed by positive temporal artery biopsy or imaging; AND</p> <p>Patient must have had a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis; AND</p> <p>Patient must have had temporal artery biopsy revealing features of giant cell arteritis at diagnosis; or</p> <p>Patient must have had evidence of large-vessel vasculitis by magnetic resonance (MR) or computed tomography (CT) angiography or PET/CT at diagnosis; or</p> <p>Patient must have had evidence of positive temporal artery halo sign by ultrasound (US) at diagnosis; AND</p> <p>The treatment must be in combination with a tapering course of corticosteroids; AND</p> <p>The treatment must not exceed 52 weeks in total including initial and continuing applications; AND</p> <p>Patient must be aged 50 years or older.</p> <p align=""justify"">Clinical symptoms of giant cell arteritis at diagnosis include unequivocal cranial symptoms of giant cell arteritis (new onset localized headache, scalp tenderness, temporal artery tenderness or decreased pulsation, ischemia related vision loss, or otherwise unexplained mouth or jaw pain upon mastication); or symptoms of polymyalgia rheumatica, defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS and must include:</p><p align=""justify"">(a) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has active giant cell arteritis including pathology reports outlining the patient&apos;s ESR or CRP levels within the last 6 weeks, or positive temporal artery biopsy or imaging; and</p><p align=""justify"">(b) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has been diagnosed with giant cell arteritis with a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) A completed authority prescription form; and</p><p align=""justify"">(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2023-08-01","Y","4708"
"14204_14196_R","Initial treatment","STREAMLINED","14196","14204","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma</p><br/><p>Initial treatment</p><br/><p>Patient must have an ECOG performance status of 2 or less; AND</p> <p>Patient must have received prior chemotherapy treatment including an anthracycline; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must be one of the following subtypes for patients with liposarcoma: (i) dedifferentiated, (ii) myxoid, (iii) round-cell, (iv) pleomorphic.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma</p><br/><p>Initial treatment</p><br/><p>Patient must have an ECOG performance status of 2 or less; AND</p> <p>Patient must have received prior chemotherapy treatment including an anthracycline; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must be one of the following subtypes for patients with liposarcoma: (i) dedifferentiated, (ii) myxoid, (iii) round-cell, (iv) pleomorphic.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2023-08-01","N","4708"
"14206_9431_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","9431","14206","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-08-01","N","4708"
"14215_10434_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","10434","14215","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-08-01","N","4708"
"14219_14202_R","null","STREAMLINED","14202","14219","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Termination of an intra-uterine pregnancy</p><br/><p>The condition must be an intra-uterine pregnancy of up to 63 days of gestation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Termination of an intra-uterine pregnancy</p><br/><p>The condition must be an intra-uterine pregnancy of up to 63 days of gestation.</p>","N","N","N","IMMEDIATE","ALL","N","2023-08-01","N","4708"
"14223_9429_R","Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","9429","14223","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-08-01","N","4708"
"14227_14228_R","null","STREAMLINED","14228","14227","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be associated with chronic renal failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be associated with chronic renal failure.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14232_14274_R","null","STREAMLINED","14274","14232","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established post-menopausal osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established post-menopausal osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14233_14234_R","null","RESTRICTED","14234","14233","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14238_14238_R","null","RESTRICTED","14238","14238","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14241_14309_R","null","RESTRICTED","14309","14241","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14252_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form meloxicam tablet 7.5 mg and pharmaceutical benefits that have the form meloxicam capsule 7.5 mg are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"14261_14235_R","null","RESTRICTED","14235","14261","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14262_14263_R","null","RESTRICTED","14263","14262","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14271_14272_R","null","RESTRICTED","14272","14271","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypertension</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must not be for the initiation of anti-hypertensive therapy; AND</p> <p>The condition must be inadequately controlled with concomitant treatment with two of the following: an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypertension</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must not be for the initiation of anti-hypertensive therapy; AND</p> <p>The condition must be inadequately controlled with concomitant treatment with two of the following: an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14273_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form meloxicam tablet 15 mg and pharmaceutical benefits that have the form meloxicam capsule 15 mg are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"14277_14242_R","null","RESTRICTED","14242","14277","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14278_14291_R","null","RESTRICTED","14291","14278","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14286_14322_R","null","STREAMLINED","14322","14286","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypocalcaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be due to renal disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypocalcaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be due to renal disease.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14288_14289_R","null","RESTRICTED","14289","14288","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypertension</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving concurrent antihypertensive therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypertension</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving concurrent antihypertensive therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14293_14305_R","null","RESTRICTED","14305","14293","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For a patient who is unable to take a solid dose form of atenolol.</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For a patient who is unable to take a solid dose form of atenolol.</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14295_14319_R","null","STREAMLINED","14319","14295","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Thiamine deficiency</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be for prophylaxis; AND</p> <p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Thiamine deficiency</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be for prophylaxis; AND</p> <p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14307_14231_R","null","STREAMLINED","14231","14307","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypophosphataemic rickets</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypophosphataemic rickets</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14314_14287_R","null","STREAMLINED","14287","14314","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypoparathyroidism</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypoparathyroidism</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14315_14296_R","null","STREAMLINED","14296","14315","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vitamin D-resistant rickets</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vitamin D-resistant rickets</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14316_14275_R","null","RESTRICTED","14275","14316","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne vulgaris</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be maintenance therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne vulgaris</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be maintenance therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14321_14259_R","null","STREAMLINED","14259","14321","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have fracture due to minimal trauma.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have fracture due to minimal trauma.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14324_14324_R","null","STREAMLINED","14324","14324","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent, unresectable or metastatic triple negative breast cancer</p><br/><p>The condition must have been (up until this drug therapy) untreated in the unresectable/metastatic disease stage; AND</p> <p>The condition must have been (up until this drug therapy) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy in breast cancer; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The condition must have both: (i) programmed cell death ligand 1 (PD-L1) expression confirmed by a validated test, (ii) a Combined Positive Score (CPS) of at least 10 at treatment initiation; AND</p> <p>Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; or</p> <p>Patient must be undergoing continuing treatment with this drug - both the following are true: (i) the condition has not progressed on active treatment with this drug, (ii) this prescription does not extend PBS subsidy beyond 24 cumulative months from the first administered dose; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent, unresectable or metastatic triple negative breast cancer</p><br/><p>The condition must have been (up until this drug therapy) untreated in the unresectable/metastatic disease stage; AND</p> <p>The condition must have been (up until this drug therapy) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy in breast cancer; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The condition must have both: (i) programmed cell death ligand 1 (PD-L1) expression confirmed by a validated test, (ii) a Combined Positive Score (CPS) of at least 10 at treatment initiation; AND</p> <p>Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; or</p> <p>Patient must be undergoing continuing treatment with this drug - both the following are true: (i) the condition has not progressed on active treatment with this drug, (ii) this prescription does not extend PBS subsidy beyond 24 cumulative months from the first administered dose; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14328_14342_R","Initial PBS-subsidised treatment (including grandfathered patients)","AUTHORITY_REQUIRED","14342","14328","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hyperkalaemia</p><br/><p>Initial PBS-subsidised treatment (including grandfathered patients)</p><br/><p>Patient must have stage 3 to stage 4 chronic kidney disease; AND</p> <p>The condition must be inadequately controlled by a low potassium diet.; AND</p> <p>Patient must have experienced at least 2 episodes of hyperkalaemia (defined as serum potassium levels of at least 6.0 mmol/L) within the 12 months prior to commencing this drug; AND</p> <p>The treatment must not be in place of emergency treatment of hyperkalaemia; AND</p> <p>Patient must be undergoing treatment with a renin angiotensin aldosterone system inhibitor; or</p> <p>Patient must be indicated for treatment with a renin angiotensin aldosterone system inhibitor, but unable to tolerate this due to prior occurrence of hyperkalaemia; AND</p> <p>Must be treated by a specialist medical practitioner with experience in the diagnosis and management of chronic kidney disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hyperkalaemia</p><br/><p>Initial PBS-subsidised treatment (including grandfathered patients)</p><br/><p>Patient must have stage 3 to stage 4 chronic kidney disease; AND</p> <p>The condition must be inadequately controlled by a low potassium diet.; AND</p> <p>Patient must have experienced at least 2 episodes of hyperkalaemia (defined as serum potassium levels of at least 6.0 mmol/L) within the 12 months prior to commencing this drug; AND</p> <p>The treatment must not be in place of emergency treatment of hyperkalaemia; AND</p> <p>Patient must be undergoing treatment with a renin angiotensin aldosterone system inhibitor; or</p> <p>Patient must be indicated for treatment with a renin angiotensin aldosterone system inhibitor, but unable to tolerate this due to prior occurrence of hyperkalaemia; AND</p> <p>Must be treated by a specialist medical practitioner with experience in the diagnosis and management of chronic kidney disease.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14329_14327_R","Continuing treatment","STREAMLINED","14327","14329","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hyperkalaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be in place of emergency treatment of hyperkalaemia; AND</p> <p>Patient must be undergoing treatment with a renin angiotensin aldosterone system inhibitor; AND</p> <p>Patient must not be undergoing dialysis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hyperkalaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be in place of emergency treatment of hyperkalaemia; AND</p> <p>Patient must be undergoing treatment with a renin angiotensin aldosterone system inhibitor; AND</p> <p>Patient must not be undergoing dialysis.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14331_5743_R","null","RESTRICTED","5743","14331","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.</p>","N","N","N","IMMEDIATE","ALL","Y","2023-09-01","N","4708"
"14332_14332_R","Treatment following intensive induction chemotherapy - Initial treatment","AUTHORITY_REQUIRED","14332","14332","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Treatment following intensive induction chemotherapy - Initial treatment</p><br/><p>Patient must have demonstrated either: (i) first complete remission, (ii) complete remission with incomplete blood count recovery following intensive induction chemotherapy; AND</p> <p>Patient must not be a candidate for, including those who choose not to proceed to, haematopoietic stem cell transplantation; AND</p> <p>Patient must have, at the time of induction therapy, a cytogenetic risk classified as either: (i) intermediate-risk, (ii) poor-risk; AND</p> <p>Patient must not have undergone a stem cell transplant; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin.</p> <p align=""justify"">A complete remission is defined as: bone marrow blasts of less than 5%, absence of blasts with Auer rods, absence of extramedullary disease, independent of blood transfusions and a recovery of peripheral blood counts with peripheral neutrophil count greater than 1.0 x 10<sup>9</sup>/L and platelet count greater than or equal to 100 x 10<sup>9</sup>/L.</p> <p align=""justify"">A complete remission with incomplete blood count recovery is defined as bone marrow blasts of less than 5%, absence of blasts with Auer rods, absence of extramedullary disease, independent of blood transfusions and a recovery of peripheral blood counts with peripheral neutrophil count less than 1.0 x 10<sup>9</sup>/L or platelet count less than 100 x 10<sup>9</sup>/L.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Treatment following intensive induction chemotherapy - Initial treatment</p><br/><p>Patient must have demonstrated either: (i) first complete remission, (ii) complete remission with incomplete blood count recovery following intensive induction chemotherapy; AND</p> <p>Patient must not be a candidate for, including those who choose not to proceed to, haematopoietic stem cell transplantation; AND</p> <p>Patient must have, at the time of induction therapy, a cytogenetic risk classified as either: (i) intermediate-risk, (ii) poor-risk; AND</p> <p>Patient must not have undergone a stem cell transplant; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin.</p> <p align=""justify"">A complete remission is defined as: bone marrow blasts of less than 5%, absence of blasts with Auer rods, absence of extramedullary disease, independent of blood transfusions and a recovery of peripheral blood counts with peripheral neutrophil count greater than 1.0 x 10<sup>9</sup>/L and platelet count greater than or equal to 100 x 10<sup>9</sup>/L.</p> <p align=""justify"">A complete remission with incomplete blood count recovery is defined as bone marrow blasts of less than 5%, absence of blasts with Auer rods, absence of extramedullary disease, independent of blood transfusions and a recovery of peripheral blood counts with peripheral neutrophil count less than 1.0 x 10<sup>9</sup>/L or platelet count less than 100 x 10<sup>9</sup>/L.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14335_5618_R","null","RESTRICTED","5618","14335","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.</p>","N","N","N","IMMEDIATE","ALL","Y","2023-09-01","N","4708"
"14337_N","null","null","null","null","null","<p>Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS subsidised imatinib after progression on this drug</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"14338_14338_R","Treatment following intensive induction chemotherapy - Continuing treatment","AUTHORITY_REQUIRED","14338","14338","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Treatment following intensive induction chemotherapy - Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have, for reasons not attributable to any cause other than AML, no more than 15% blasts in either the: (i) bone marrow, (ii) peripheral blood; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Treatment following intensive induction chemotherapy - Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have, for reasons not attributable to any cause other than AML, no more than 15% blasts in either the: (i) bone marrow, (ii) peripheral blood; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14339_14326_R","Combination use with chlorambucil only","STREAMLINED","14326","14339","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL)</p><br/><p>Combination use with chlorambucil only</p><br/><p>The condition must be CD20 positive; AND</p> <p>The condition must be previously untreated; AND</p> <p>The treatment must be in combination with chlorambucil; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition.</p> <p align=""justify"">Treatment must be discontinued in patients who experience disease progression whilst on this treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL)</p><br/><p>Combination use with chlorambucil only</p><br/><p>The condition must be CD20 positive; AND</p> <p>The condition must be previously untreated; AND</p> <p>The treatment must be in combination with chlorambucil; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition.</p> <p align=""justify"">Treatment must be discontinued in patients who experience disease progression whilst on this treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2023-09-01","N","4708"
"14354_10807_R","Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply","AUTHORITY_REQUIRED","10807","14354","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14359_N","null","null","null","null","null","<p align=""justify"">The risk of serious muscle toxicity is increased if this drug is used concomitantly with HMG CoA reductase inhibitors or other fibrates. Such combination therapy should be used with caution in patients with severe combined dyslipidaemia and high cardiovascular risk without any history of muscular disease and patients monitored closely for chronic signs of muscle toxicity.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"14361_14362_R","Triple combination therapy consisting of carfilzomib, lenalidomide and dexamethasone","AUTHORITY_REQUIRED","14362","14361","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Triple combination therapy consisting of carfilzomib, lenalidomide and dexamethasone</p><br/><p>Patient must be undergoing concurrent treatment with carfilzomib obtained through the PBS; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Triple combination therapy consisting of carfilzomib, lenalidomide and dexamethasone</p><br/><p>Patient must be undergoing concurrent treatment with carfilzomib obtained through the PBS; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing.</p>","N","N","N","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14365_14366_R","Continuing treatment in a person with a mature skeleton or aged 18 years or older","AUTHORITY_REQUIRED","14366","14365","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe growth hormone deficiency</p><br/><p>Continuing treatment in a person with a mature skeleton or aged 18 years or older</p><br/><p>Must be treated by an endocrinologist; AND</p> <p>Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause in a patient with a mature skeleton; or</p> <p>Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease in a patient with chronological age of 18 years or older; or</p> <p>Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe growth hormone deficiency</p><br/><p>Continuing treatment in a person with a mature skeleton or aged 18 years or older</p><br/><p>Must be treated by an endocrinologist; AND</p> <p>Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause in a patient with a mature skeleton; or</p> <p>Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease in a patient with chronological age of 18 years or older; or</p> <p>Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14387_14387_R","null","AUTHORITY_REQUIRED","14387","14387","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The treatment must be for prevention of nausea and vomiting associated with moderate to highly emetogenic anti-cancer therapy; AND</p> <p>The treatment must be in combination with dexamethasone, unless contraindicated; AND</p> <p>Patient must be unable to swallow; or</p> <p>Patient must be contraindicated to oral anti-emetics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The treatment must be for prevention of nausea and vomiting associated with moderate to highly emetogenic anti-cancer therapy; AND</p> <p>The treatment must be in combination with dexamethasone, unless contraindicated; AND</p> <p>Patient must be unable to swallow; or</p> <p>Patient must be contraindicated to oral anti-emetics.</p>","N","N","N","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14388_14389_R","Initial treatment for Cycles 1 to 3","STREAMLINED","14389","14388","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Initial treatment for Cycles 1 to 3</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must be in combination with lenalidomide and dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must not have previously received this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Provide details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of the most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response once only through the Authority application for lenalidomide.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Initial treatment for Cycles 1 to 3</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must be in combination with lenalidomide and dexamethasone; AND</p> <p>Patient must have progressive disease after at least one prior therapy; AND</p> <p>Patient must not have previously received this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Provide details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of the most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response once only through the Authority application for lenalidomide.</p>","N","N","N","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14393_14420_R","Continuing/maintenance treatment in an adult where treatment was initiated in adulthood","AUTHORITY_REQUIRED","14420","14393","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment in an adult where treatment was initiated in adulthood</p><br/><p>Patient must be undergoing continuation of existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated after the patient''s 19th birthday; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>The treatment must be each of: (i) occurring from week 104 onwards relative to the first administered dose, (ii) demonstrating a clinically meaningful response; or</p> <p>The treatment must be occurring within the first 104 weeks from the first administered dose; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">Where this authority application seeks to continue treatment beyond the first 104 weeks of treatment, comprehensive assessment must be undertaken periodically and documented, involving the patient and the treating physician to establish agreement that treatment is continuing to produce a clinically meaningful response.</p><p align=""justify"">A clinically meaningful response is present where an improvement, stabilisation or minimal decline in symptoms has occurred as a result of this drug treatment and where there is agreement between the treating physician and patient over what constitutes improvement, stabilisation, or minimal decline.</p><p align=""justify"">PBS subsidy must cease if there is no agreement on whether a clinically meaningful response is present.</p><p align=""justify"">Undertake re-assessments for a clinically meaningful response at least every six months. Document these re-assessments in the patient&apos;s medical records.</p><p align=""justify"">In undertaking comprehensive assessments, where practical, a clinically meaningful response assessment encompasses the patient&apos;s motor function as assessed using an instrument like the Revised Upper Limb Module (RULM), Hammersmith Functional Motor Scale - Expanded (HFMSE) or 6-minute walk test (6MWT), and the patient&apos;s quality of life including, but not limited to, level of independence. Quality of life may be informed by use of the SMA Health Index (SMA-HI) or SMA Functional Rating Scale (SMAFRS).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment in an adult where treatment was initiated in adulthood</p><br/><p>Patient must be undergoing continuation of existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated after the patient''s 19th birthday; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>The treatment must be each of: (i) occurring from week 104 onwards relative to the first administered dose, (ii) demonstrating a clinically meaningful response; or</p> <p>The treatment must be occurring within the first 104 weeks from the first administered dose; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">Where this authority application seeks to continue treatment beyond the first 104 weeks of treatment, comprehensive assessment must be undertaken periodically and documented, involving the patient and the treating physician to establish agreement that treatment is continuing to produce a clinically meaningful response.</p><p align=""justify"">A clinically meaningful response is present where an improvement, stabilisation or minimal decline in symptoms has occurred as a result of this drug treatment and where there is agreement between the treating physician and patient over what constitutes improvement, stabilisation, or minimal decline.</p><p align=""justify"">PBS subsidy must cease if there is no agreement on whether a clinically meaningful response is present.</p><p align=""justify"">Undertake re-assessments for a clinically meaningful response at least every six months. Document these re-assessments in the patient&apos;s medical records.</p><p align=""justify"">In undertaking comprehensive assessments, where practical, a clinically meaningful response assessment encompasses the patient&apos;s motor function as assessed using an instrument like the Revised Upper Limb Module (RULM), Hammersmith Functional Motor Scale - Expanded (HFMSE) or 6-minute walk test (6MWT), and the patient&apos;s quality of life including, but not limited to, level of independence. Quality of life may be informed by use of the SMA Health Index (SMA-HI) or SMA Functional Rating Scale (SMAFRS).</p>","N","N","N","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14394_14392_R","Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhood","AUTHORITY_REQUIRED","14392","14394","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhood</p><br/><p>Patient must be undergoing continuation of existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated prior to the patient''s 19th birthday for SMA type IIIB/IIIC; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant &apos;Note&apos; attached to this listing.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhood</p><br/><p>Patient must be undergoing continuation of existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated prior to the patient''s 19th birthday for SMA type IIIB/IIIC; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant &apos;Note&apos; attached to this listing.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","N","N","N","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14406_14443_R","null","STREAMLINED","14443","14406","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The treatment must be in combination with dexamethasone, unless contraindicated; AND</p> <p>The treatment must be for prevention of nausea and vomiting associated with moderate to highly emetogenic anti-cancer therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The treatment must be in combination with dexamethasone, unless contraindicated; AND</p> <p>The treatment must be for prevention of nausea and vomiting associated with moderate to highly emetogenic anti-cancer therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14409_14459_R","Continuing/maintenance treatment in an adult where treatment was initiated in adulthood","AUTHORITY_REQUIRED","14459","14409","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment in an adult where treatment was initiated in adulthood</p><br/><p>The treatment must be each of: (i) occurring from week 104 onwards relative to the first administered dose, (ii) demonstrating a clinically meaningful response; or</p> <p>The treatment must be occurring within the first 104 weeks from the first administered dose; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing continuation of existing PBS-subsidised treatment with this drug; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.</p> <p align=""justify"">Where this authority application seeks to continue treatment beyond the first 104 weeks of treatment, comprehensive assessment must be undertaken periodically and documented, involving the patient and the treating physician to establish agreement that treatment is continuing to produce a clinically meaningful response.</p><p align=""justify"">A clinically meaningful response is present where an improvement, stabilisation or minimal decline in symptoms has occurred as a result of this drug treatment and where there is agreement between the treating physician and patient over what constitutes improvement, stabilisation, or minimal decline.</p><p align=""justify"">PBS subsidy must cease if there is no agreement on whether a clinically meaningful response is present.</p><p align=""justify"">Undertake re-assessments for a clinically meaningful response at least every six months. Document these re-assessments in the patient&apos;s medical records.</p><p align=""justify"">In undertaking comprehensive assessments, where practical, a clinically meaningful response assessment encompasses the patient&apos;s motor function as assessed using an instrument like the Revised Upper Limb Module (RULM), Hammersmith Functional Motor Scale - Expanded (HFMSE) or 6-minute walk test (6MWT), and the patient&apos;s quality of life including, but not limited to, level of independence. Quality of life may be informed by use of the SMA Health Index (SMA-HI) or SMA Functional Rating Scale (SMAFRS).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment in an adult where treatment was initiated in adulthood</p><br/><p>The treatment must be each of: (i) occurring from week 104 onwards relative to the first administered dose, (ii) demonstrating a clinically meaningful response; or</p> <p>The treatment must be occurring within the first 104 weeks from the first administered dose; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing continuation of existing PBS-subsidised treatment with this drug; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.</p> <p align=""justify"">Where this authority application seeks to continue treatment beyond the first 104 weeks of treatment, comprehensive assessment must be undertaken periodically and documented, involving the patient and the treating physician to establish agreement that treatment is continuing to produce a clinically meaningful response.</p><p align=""justify"">A clinically meaningful response is present where an improvement, stabilisation or minimal decline in symptoms has occurred as a result of this drug treatment and where there is agreement between the treating physician and patient over what constitutes improvement, stabilisation, or minimal decline.</p><p align=""justify"">PBS subsidy must cease if there is no agreement on whether a clinically meaningful response is present.</p><p align=""justify"">Undertake re-assessments for a clinically meaningful response at least every six months. Document these re-assessments in the patient&apos;s medical records.</p><p align=""justify"">In undertaking comprehensive assessments, where practical, a clinically meaningful response assessment encompasses the patient&apos;s motor function as assessed using an instrument like the Revised Upper Limb Module (RULM), Hammersmith Functional Motor Scale - Expanded (HFMSE) or 6-minute walk test (6MWT), and the patient&apos;s quality of life including, but not limited to, level of independence. Quality of life may be informed by use of the SMA Health Index (SMA-HI) or SMA Functional Rating Scale (SMAFRS).</p> <p align=""justify"">Literature references for various instruments measuring motor function and quality of life in the context of spinal muscular atrophy are:</p><p align=""justify"">Revised Upper Limb Module</p><p align=""justify"">Mazzone et al. 2017. Revised upper limb module for spinal muscular atrophy: Development of a new module. <i>Muscle &amp; Nerve</i> 55(6):869-874</p><p align=""justify"">Hammersmith Functional Motor Scale - Expanded</p><p align=""justify"">Ramsey et al. 2017. Revised Hammersmith Scale for spinal muscular atrophy: A SMA specific clinical outcome assessment tool. <i>PLoS ONE</i> 12(2): e0172346. doi:10.1371/journal.pone.0172346.</p><p align=""justify"">6-Minute Walk Test (6MWT)</p><p align=""justify"">American Thoracic Society. 2002. ATS statement: Guidelines for the six-minute walk test. <i>American Journal of Respiratory and Critical Care Medicine</i> 166(1), pp 111-117</p><p align=""justify"">The National Hearth Foundation of Australia has 6MWT test standardised instructions and recording forms located at: https://www.heartonline.org.au/resources/documents-and-links#exercise</p><p align=""justify"">SMA Health Index</p><p align=""justify"">Zizzi et al. 2021. The Spinal Muscular Atrophy Health Index (SMA-HI): A Novel Outcome for Measuring How a Patient Feels and Functions. <i>Muscle &amp; Nerve</i> 63(10), pp 837-844</p><p align=""justify"">SMA Functional Rating Scale</p><p align=""justify"">Elsheikh et al. 2018. Reliability of Spinal Muscular Atrophy Functional Rating Scale (SMAFRS) in Ambulatory Adults with Spinal Muscular Atrophy. <i>Neurology</i> April (15 Supplement) P4.452</p>","N","N","N","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14411_14449_R","Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","14449","14411","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 24 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 24 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14416_14416_R","null","STREAMLINED","14416","14416","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer</p><br/><p>The condition must have progressed on/following both: (i) platinum-based chemotherapy, (ii) programmed cell death 1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or</p> <p>The condition must have progressed on/following platinum-based chemotherapy, whilst PD-1/PD-L1 inhibitor therapy resulted in an intolerance that required treatment cessation; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be undergoing treatment with this drug for the first time; or</p> <p>Patient must be undergoing continuing treatment with this drug, with each of the following being true: (i) all other PBS eligibility criteria in this restriction are met, (ii) disease progression is absent.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer</p><br/><p>The condition must have progressed on/following both: (i) platinum-based chemotherapy, (ii) programmed cell death 1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or</p> <p>The condition must have progressed on/following platinum-based chemotherapy, whilst PD-1/PD-L1 inhibitor therapy resulted in an intolerance that required treatment cessation; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be undergoing treatment with this drug for the first time; or</p> <p>Patient must be undergoing continuing treatment with this drug, with each of the following being true: (i) all other PBS eligibility criteria in this restriction are met, (ii) disease progression is absent.</p>","N","N","N","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14417_C","null","null","null","null","null","<p align=""justify"">Flecainide acetate should be avoided in patients with poor cardiac function.</p>","N","Y","N","null","null","N","2015-06-01","N","4708"
"14419_14363_R","Continuing treatment for Cycles 3 to 12","STREAMLINED","14363","14419","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment for Cycles 3 to 12</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with lenalidomide and dexamethasone; AND</p> <p>Patient must not have progressive disease while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment for Cycles 3 to 12</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with lenalidomide and dexamethasone; AND</p> <p>Patient must not have progressive disease while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14422_14433_R","Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhood","AUTHORITY_REQUIRED","14433","14422","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhood</p><br/><p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Patient must be undergoing continuation of existing PBS-subsidised treatment with this drug; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhood</p><br/><p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Patient must be undergoing continuation of existing PBS-subsidised treatment with this drug; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p>","N","N","N","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14444_14364_R","Continuing treatment for Cycles 13 onwards","STREAMLINED","14364","14444","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment for Cycles 13 onwards</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with lenalidomide and dexamethasone; AND</p> <p>Patient must not have progressive disease while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Continuing treatment for Cycles 13 onwards</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with lenalidomide and dexamethasone; AND</p> <p>Patient must not have progressive disease while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2023-10-01","N","4708"
"14458_N","null","null","null","null","null","<p align=""justify"">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"14463_C","null","null","null","null","null","<p align=""justify"">This drug is an irreversible monoamine oxidase inhibitor.</p>","N","Y","N","null","null","N","2015-06-01","N","4708"
"14473_14608_R","Initial treatment - Induction of remission","AUTHORITY_REQUIRED","14608","14473","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Initial treatment - Induction of remission</p><br/><p>Patient must have a history of symptoms of oesophageal dysfunction; AND</p> <p>Patient must have eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy confirming the presence of at least 15 eosinophils in at least one high power field (hpf); corresponding to approximately 60 eosinophils per mm2 hpf; AND</p> <p>Patient must not receive more than 90 days of treatment under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) gastroenterologist, (ii) surgeon experienced in the management of patients with eosinophilic oesophagitis, (iii) physician experienced in the management of patients with eosinophilic oesophagitis.</p> <p align=""justify"">Applications for treatment of this condition must be received within 12 weeks of biopsy.</p> <p align=""justify"">Symptoms of oesophageal dysfunction include at least one of the following: dysphasia, odynophagia, transient or self-cleared food impaction, chest pain, epigastric discomfort, vomiting/regurgitation.</p> <p align=""justify"">Diagnostic sensitivity increases with the number of biopsies and can be optimised, where necessary, by taking at least eight biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction).</p> <p align=""justify"">After prescribing the Initial induction treatment with budesonide, a histologic assessment must be conducted within 48 weeks of initiating treatment to determine the patient&apos;s eligibility for continuing therapy.</p><p align=""justify"">The histologic assessment should be conducted no later than 2 weeks prior to completing the PBS-subsidised First continuing maintenance treatment course to avoid an interruption of supply for continuing therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Initial treatment - Induction of remission</p><br/><p>Patient must have a history of symptoms of oesophageal dysfunction; AND</p> <p>Patient must have eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy confirming the presence of at least 15 eosinophils in at least one high power field (hpf); corresponding to approximately 60 eosinophils per mm2 hpf; AND</p> <p>Patient must not receive more than 90 days of treatment under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) gastroenterologist, (ii) surgeon experienced in the management of patients with eosinophilic oesophagitis, (iii) physician experienced in the management of patients with eosinophilic oesophagitis.</p> <p align=""justify"">Applications for treatment of this condition must be received within 12 weeks of biopsy.</p> <p align=""justify"">Symptoms of oesophageal dysfunction include at least one of the following: dysphasia, odynophagia, transient or self-cleared food impaction, chest pain, epigastric discomfort, vomiting/regurgitation.</p> <p align=""justify"">Diagnostic sensitivity increases with the number of biopsies and can be optimised, where necessary, by taking at least eight biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction).</p> <p align=""justify"">After prescribing the Initial induction treatment with budesonide, a histologic assessment must be conducted within 48 weeks of initiating treatment to determine the patient&apos;s eligibility for continuing therapy.</p><p align=""justify"">The histologic assessment should be conducted no later than 2 weeks prior to completing the PBS-subsidised First continuing maintenance treatment course to avoid an interruption of supply for continuing therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14480_14499_R","Subsequent continuing treatment","STREAMLINED","14499","14480","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14481_14507_R","First continuing treatment - balance of supply","AUTHORITY_REQUIRED","14507","14481","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14485_14485_R","Subsequent continuing treatment","STREAMLINED","14485","14485","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14490_14488_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply","AUTHORITY_REQUIRED","14488","14490","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14494_14568_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","14568","14494","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient&apos;s medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the active joint count, ESR and/or CRP result and date of result;</p><p align=""justify"">(b) the most recent biological agent and the date of the last continuing prescription.</p><p align=""justify"">(c) If applicable, the new baseline scores.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient&apos;s medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the active joint count, ESR and/or CRP result and date of result;</p><p align=""justify"">(b) the most recent biological agent and the date of the last continuing prescription.</p><p align=""justify"">(c) If applicable, the new baseline scores.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14495_14590_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","14590","14495","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14495_C","null","null","null","null","null","<p align=""justify"">Abuse of clonazepam has been reported. Refer to the current product information.</p>","N","Y","N","null","null","N","2015-06-01","N","4708"
"14501_14623_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","14623","14501","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14503_14548_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply","AUTHORITY_REQUIRED","14548","14503","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 22 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 22 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14511_C","null","null","null","null","null","<p align=""justify"">This drug causes birth defects. </p>","N","Y","N","null","null","N","2015-07-01","N","4708"
"14512_14553_R","Initial 4 - Re-treatment (Whole body)","AUTHORITY_REQUIRED","14553","14512","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 4 - Re-treatment (Whole body)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have a documented history of severe chronic plaque psoriasis of the whole body; AND</p> <p>Patient must be undergoing re-treatment with this biological medicine for this PBS indication after an initial adequate response to the most recent treatment course, but has since experienced at least one of the following: (i) a disease flare where the PASI score has worsened (increased) by at least 50%, (ii) the current PASI score has returned above 15; AND</p> <p>Patient must not have failed more than once to achieve an adequate response with etanercept; AND</p> <p>Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p>Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 4 - Re-treatment (Whole body)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have a documented history of severe chronic plaque psoriasis of the whole body; AND</p> <p>Patient must be undergoing re-treatment with this biological medicine for this PBS indication after an initial adequate response to the most recent treatment course, but has since experienced at least one of the following: (i) a disease flare where the PASI score has worsened (increased) by at least 50%, (ii) the current PASI score has returned above 15; AND</p> <p>Patient must not have failed more than once to achieve an adequate response with etanercept; AND</p> <p>Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p>Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14512_C","null","null","null","null","null","<p align=""justify"">This drug has been reported to cause other frequent and potentially serious toxicity.</p>","N","Y","N","null","null","N","2015-07-01","N","4708"
"14514_14604_R","Subsequent continuing treatment","STREAMLINED","14604","14514","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14522_N","null","null","null","null","null","<p align=""justify"">Coloplast dressings are available via a range of distributors. However, Coloplast&apos;s principal agreement to ensure correct RPBS Price to Pharmacy and ready supply has been secured with Independence Australia on 1300 788 855 and BrightSky on 1300 290 400. Please note that Coloplast is unable to guarantee ready supply or rebate for price differences on purchases outside these distributors.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"14526_N","null","null","null","null","null","<p align=""justify"">Hartmann wound dressings are available through HARTMANN and Independence Australia only. If you would like to order Hartmann Wound Care products, please call HARTMANN customer service on 1800 805 839 or Independence Australia on 1300 788 855.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"14527_14471_R","null","STREAMLINED","14471","14527","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of greater than 40%; AND</p> <p>Patient must have documented evidence of structural changes in the heart on echocardiography that would be expected to cause diastolic dysfunction (e.g. left ventricular hypertrophy); AND</p> <p>Patient must have documented evidence of at least one of the following: (i) diastolic dysfunction with high filling pressure on echocardiography, stress echocardiography or cardiac catheterisation; (ii) hospitalisation for heart failure in the 12 months prior to initiating treatment with this drug; (iii) requirement for intravenous diuretic therapy in the 12 months prior to initiating treatment with this drug; (iv) elevated N-terminal pro brain natriuretic peptide (NT-proBNP) levels in the absence of another cause; AND</p> <p>Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of greater than 40%; AND</p> <p>Patient must have documented evidence of structural changes in the heart on echocardiography that would be expected to cause diastolic dysfunction (e.g. left ventricular hypertrophy); AND</p> <p>Patient must have documented evidence of at least one of the following: (i) diastolic dysfunction with high filling pressure on echocardiography, stress echocardiography or cardiac catheterisation; (ii) hospitalisation for heart failure in the 12 months prior to initiating treatment with this drug; (iii) requirement for intravenous diuretic therapy in the 12 months prior to initiating treatment with this drug; (iv) elevated N-terminal pro brain natriuretic peptide (NT-proBNP) levels in the absence of another cause; AND</p> <p>Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14536_14621_R","Subsequent continuing treatment","STREAMLINED","14621","14536","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14537_14567_R","First continuing treatment","STREAMLINED","14567","14537","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14541_14496_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","14496","14541","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient&apos;s medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient&apos;s medical records.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient&apos;s medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the active joint count, ESR and/or CRP result and date of results;</p><p align=""justify"">(b) details of prior treatment, including dose and date/duration of treatment.</p><p align=""justify"">(c) If applicable, details of any contraindications/intolerances.</p><p align=""justify"">(d) If applicable, the maximum tolerated dose of methotrexate.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient&apos;s medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient&apos;s medical records.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient&apos;s medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the active joint count, ESR and/or CRP result and date of results;</p><p align=""justify"">(b) details of prior treatment, including dose and date/duration of treatment.</p><p align=""justify"">(c) If applicable, details of any contraindications/intolerances.</p><p align=""justify"">(d) If applicable, the maximum tolerated dose of methotrexate.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14545_14502_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","14502","14545","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient&apos;s medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient&apos;s medical records.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient&apos;s medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the active joint count, ESR and/or CRP result and date of results;</p><p align=""justify"">(b) details of prior treatment, including dose and date/duration of treatment.</p><p align=""justify"">(c) If applicable, details of any contraindications/intolerances.</p><p align=""justify"">(d) If applicable, the maximum tolerated dose of methotrexate.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient&apos;s medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient&apos;s medical records.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient&apos;s medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the active joint count, ESR and/or CRP result and date of results;</p><p align=""justify"">(b) details of prior treatment, including dose and date/duration of treatment.</p><p align=""justify"">(c) If applicable, details of any contraindications/intolerances.</p><p align=""justify"">(d) If applicable, the maximum tolerated dose of methotrexate.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14549_14509_R","Completion of course - treatment covering weeks 16 to 24 (Whole body)","STREAMLINED","14509","14549","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Completion of course - treatment covering weeks 16 to 24 (Whole body)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing current PBS-subsidised treatment with this biological medicine, with the intention to complete the remainder of a 24-week treatment course with this biological medicine; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine, but within 8 weeks of the last administered dose; AND</p> <p>Patient must have demonstrated an adequate response to treatment; AND</p> <p>Patient must not receive more than 8 weeks of treatment with etanercept under this restriction.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p>The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Completion of course - treatment covering weeks 16 to 24 (Whole body)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing current PBS-subsidised treatment with this biological medicine, with the intention to complete the remainder of a 24-week treatment course with this biological medicine; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine, but within 8 weeks of the last administered dose; AND</p> <p>Patient must have demonstrated an adequate response to treatment; AND</p> <p>Patient must not receive more than 8 weeks of treatment with etanercept under this restriction.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p>The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14550_14513_R","Initial 1 treatment (Whole body) - biological medicine-naive patient","AUTHORITY_REQUIRED","14513","14550","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1 treatment (Whole body) - biological medicine-naive patient</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have lesions present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND</p> <p>Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:</p><p align=""justify"">(a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy.</p><p align=""justify"">A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. Provide in this authority application, and document in the patient&apos;s medical records, each of:</p><p align=""justify"">(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;</p><p align=""justify"">(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);</p><p align=""justify"">(iii) the PASI score that followed each prior therapy trialled;</p><p align=""justify"">(iv) the date the PASI scores were determined.</p><p align=""justify"">Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of: (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1 treatment (Whole body) - biological medicine-naive patient</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have lesions present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND</p> <p>Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:</p><p align=""justify"">(a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy.</p><p align=""justify"">A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. Provide in this authority application, and document in the patient&apos;s medical records, each of:</p><p align=""justify"">(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;</p><p align=""justify"">(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);</p><p align=""justify"">(iii) the PASI score that followed each prior therapy trialled;</p><p align=""justify"">(iv) the date the PASI scores were determined.</p><p align=""justify"">Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of: (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14551_14577_R","Initial 4 - Re-treatment (face, hand, foot)","AUTHORITY_REQUIRED","14577","14551","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 4 - Re-treatment (face, hand, foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND</p> <p>Patient must be undergoing re-treatment with this biological medicine for this PBS indication after an initial adequate response to the most recent treatment course, but has since experienced at least one of the following: (i) all PASI sub-measures (redness, thickness, scaling) are rated as ''moderate'' to ''severe'', (ii) at least 2 of the 3 PASI sub-measures are rated as ''severe'' to ''very severe'', (iii) the skin area affected has increased by at least 50% since the last administered dose, (iv) the skin area affected is at least 30% of the total skin area of the face/hand/foot; AND</p> <p>Patient must not have failed more than once to achieve an adequate response with etanercept; AND</p> <p>Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p>Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 4 - Re-treatment (face, hand, foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND</p> <p>Patient must be undergoing re-treatment with this biological medicine for this PBS indication after an initial adequate response to the most recent treatment course, but has since experienced at least one of the following: (i) all PASI sub-measures (redness, thickness, scaling) are rated as ''moderate'' to ''severe'', (ii) at least 2 of the 3 PASI sub-measures are rated as ''severe'' to ''very severe'', (iii) the skin area affected has increased by at least 50% since the last administered dose, (iv) the skin area affected is at least 30% of the total skin area of the face/hand/foot; AND</p> <p>Patient must not have failed more than once to achieve an adequate response with etanercept; AND</p> <p>Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p>Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14555_C","null","null","null","null","null","<p align=""justify"">Neutropenia and agranulocytosis are more frequent in the elderly, especially in the early months of therapy.</p>","N","Y","N","null","null","N","2015-06-01","N","4708"
"14559_N","null","null","null","null","null","<p align=""justify"">Except in cases of hypopituitarism or primary amenorrhoea, the patient should have been adequately treated with clomifene citrate and/or gonadorelin and failed to have conceived.</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"14562_N","null","null","null","null","null","<p align=""justify"">Patients with hyperprolactinaemia should have had appropriate surgical or medical treatment prior to treatment.</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"14574_14544_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","14544","14574","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient&apos;s medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the active joint count, ESR and/or CRP result and date of result;</p><p align=""justify"">(b) the most recent biological agent and the date of the last continuing prescription.</p><p align=""justify"">(c) If applicable, the new baseline scores.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient&apos;s medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the active joint count, ESR and/or CRP result and date of result;</p><p align=""justify"">(b) the most recent biological agent and the date of the last continuing prescription.</p><p align=""justify"">(c) If applicable, the new baseline scores.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14578_14576_R","Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years","AUTHORITY_REQUIRED","14576","14578","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND</p> <p>The condition must be affecting the whole body - all subsequent authority applications to this application will be made under treatment phases that feature the words ''whole body''; or</p> <p>The condition must be limited to the face/hand/foot - all subsequent authority applications to this application will be made under treatment phases that feature the words ''face, hand, foot''; AND</p> <p>Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; or</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND</p> <p>The condition must be affecting the whole body - all subsequent authority applications to this application will be made under treatment phases that feature the words ''whole body''; or</p> <p>The condition must be limited to the face/hand/foot - all subsequent authority applications to this application will be made under treatment phases that feature the words ''face, hand, foot''; AND</p> <p>Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; or</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14598_14508_R","Completion of course - treatment covering weeks 16 to 24 (Face, hand, foot)","STREAMLINED","14508","14598","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Completion of course - treatment covering weeks 16 to 24 (Face, hand, foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing current PBS-subsidised treatment with this biological medicine, with the intention to complete the remainder of a 24-week treatment course with this biological medicine; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine, but within 8 weeks of the last administered dose; AND</p> <p>Patient must have demonstrated an adequate response to treatment; AND</p> <p>Patient must not receive more than 8 weeks of treatment with etanercept under this restriction.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p>The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Completion of course - treatment covering weeks 16 to 24 (Face, hand, foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing current PBS-subsidised treatment with this biological medicine, with the intention to complete the remainder of a 24-week treatment course with this biological medicine; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine, but within 8 weeks of the last administered dose; AND</p> <p>Patient must have demonstrated an adequate response to treatment; AND</p> <p>Patient must not receive more than 8 weeks of treatment with etanercept under this restriction.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p>The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14599_14554_R","Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient","AUTHORITY_REQUIRED","14554","14599","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND</p> <p>Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:</p><p align=""justify"">(a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or</p><p align=""justify"">(b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy</p><p align=""justify"">Provide in this authority application, and document in the patient&apos;s medical records, each of:</p><p align=""justify"">(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;</p><p align=""justify"">(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);</p><p align=""justify"">(iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled;</p><p align=""justify"">(iv) the dates that response assessments were determined.</p><p align=""justify"">Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment:</p><p align=""justify"">(v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);</p><p align=""justify"">(vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.</p> <p>Where a patient has had a 12 month treatment break, the length of the break is measured from the date the most recent treatment was stopped to the date of the application to re-commence treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND</p> <p>Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:</p><p align=""justify"">(a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or</p><p align=""justify"">(b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy</p><p align=""justify"">Provide in this authority application, and document in the patient&apos;s medical records, each of:</p><p align=""justify"">(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;</p><p align=""justify"">(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);</p><p align=""justify"">(iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled;</p><p align=""justify"">(iv) the dates that response assessments were determined.</p><p align=""justify"">Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment:</p><p align=""justify"">(v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);</p><p align=""justify"">(vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.</p> <p>Where a patient has had a 12 month treatment break, the length of the break is measured from the date the most recent treatment was stopped to the date of the application to re-commence treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14607_14563_R","Continuing treatment","STREAMLINED","14563","14607","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment-resistant migraine</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist; AND</p> <p>Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved and maintained at least 50% reduction from baseline in the number of migraine headache days per month; AND</p> <p>Patient must continue to be appropriately managed for medication overuse headache.</p> <p align=""justify"">Patient must have the number of migraine headache days per month documented in their medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment-resistant migraine</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist; AND</p> <p>Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved and maintained at least 50% reduction from baseline in the number of migraine headache days per month; AND</p> <p>Patient must continue to be appropriately managed for medication overuse headache.</p> <p align=""justify"">Patient must have the number of migraine headache days per month documented in their medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14616_14629_R","First continuing treatment","STREAMLINED","14629","14616","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14624_12261_R","Balance of supply - Initial 1, 2, 3 or 4 treatment (Whole body, or, face/hand/foot)","AUTHORITY_REQUIRED","12261","14624","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial 1, 2, 3 or 4 treatment (Whole body, or, face/hand/foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing current PBS-subsidised treatment with this biological medicine, but has received insufficient therapy with this biological medicine to complete 16 weeks treatment available under any of the initial treatment phases (regardless of the affected body area): (i) Initial 1, (ii) Initial 2, (iii) Initial 3, (iv) Initial 4; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial 1, 2, 3 or 4 treatment (Whole body, or, face/hand/foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing current PBS-subsidised treatment with this biological medicine, but has received insufficient therapy with this biological medicine to complete 16 weeks treatment available under any of the initial treatment phases (regardless of the affected body area): (i) Initial 1, (ii) Initial 2, (iii) Initial 3, (iv) Initial 4; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14634_14542_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply","AUTHORITY_REQUIRED","14542","14634","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; AND</p> <p>The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; AND</p> <p>The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14637_14638_R","First continuing treatment","STREAMLINED","14638","14637","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient&apos;s medical records. These values will be used for patients who transition to subcutaneous form of infliximab.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient&apos;s medical records. These values will be used for patients who transition to subcutaneous form of infliximab.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14639_14585_R","First continuing treatment","STREAMLINED","14585","14639","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient&apos;s medical records. These values will be used for patients who transition to subcutaneous form of infliximab.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient&apos;s medical records. These values will be used for patients who transition to subcutaneous form of infliximab.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14641_12334_R","Balance of supply - Initial 1, 2 or 3 treatment (Whole body, or, face/hand/foot)","AUTHORITY_REQUIRED","12334","14641","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial 1, 2 or 3 treatment (Whole body, or, face/hand/foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing current PBS-subsidised treatment with this biological medicine, but has received insufficient therapy with this biological medicine to complete 3 doses available under any of the initial treatment phases (regardless of the affected body area): (i) Initial 1, (ii) Initial 2, (iii) Initial 3; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>The treatment must provide no more than the balance of 3 doses available under any of the initial treatment phases.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial 1, 2 or 3 treatment (Whole body, or, face/hand/foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing current PBS-subsidised treatment with this biological medicine, but has received insufficient therapy with this biological medicine to complete 3 doses available under any of the initial treatment phases (regardless of the affected body area): (i) Initial 1, (ii) Initial 2, (iii) Initial 3; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>The treatment must provide no more than the balance of 3 doses available under any of the initial treatment phases.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14644_14504_R","Subsequent continuing treatment","STREAMLINED","14504","14644","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient&apos;s medical records. These values will be used for patients who transition to subcutaneous form of infliximab.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient&apos;s medical records. These values will be used for patients who transition to subcutaneous form of infliximab.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14645_14505_R","Subsequent continuing treatment","STREAMLINED","14505","14645","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient&apos;s medical records. These values will be used for patients who transition to subcutaneous form of infliximab.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient&apos;s medical records. These values will be used for patients who transition to subcutaneous form of infliximab.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14646_14555_R","Subsequent continuing treatment","STREAMLINED","14555","14646","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p>","N","N","N","IMMEDIATE","ALL","N","2023-11-01","N","4708"
"14654_14655_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","14655","14654","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-12-01","Y","4708"
"14657_14730_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","14730","14657","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14658_14714_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","14714","14658","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-12-01","Y","4708"
"14660_14670_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","14670","14660","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted for the purposes of administering this restriction can be found on the Services Australia website at www.servicesaustralia.gov.au</p> <p align=""justify"">For details on the appropriate minimum exercise program that will be accepted for the purposes of administering this restriction, please refer to the Services Australia website at www.servicesaustralia.gov.au</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-12-01","Y","4708"
"14661_14703_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","14703","14661","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14663_14713_R","First continuing treatment","AUTHORITY_REQUIRED","14713","14663","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-12-01","Y","4708"
"14666_9559_R","Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","9559","14666","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 18 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 18 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 18 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 18 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 18 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 18 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 18 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 18 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14669_14670_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","14670","14669","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Details of the NSAIDs trialled, their doses and duration of treatment must be provided at the time of application.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the reason a higher dose cannot be used must be provided.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be provided.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, details of the nature and severity of this intolerance must be provided.</p> <p align=""justify"">All relevant details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the reason this criterion cannot be satisfied must be provided at the time of application.</p> <p align=""justify"">The following must be provided at the time of application:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) details of the completed Exercise Program Self Certification Form (commencement and finish date); and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p><p align=""justify"">All supporting evidence, including the completed Exercise Program Self Certification Form must be kept in the patient&apos;s medical records.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Details of the NSAIDs trialled, their doses and duration of treatment must be provided at the time of application.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the reason a higher dose cannot be used must be provided.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be provided.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, details of the nature and severity of this intolerance must be provided.</p> <p align=""justify"">All relevant details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the reason this criterion cannot be satisfied must be provided at the time of application.</p> <p align=""justify"">The following must be provided at the time of application:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) details of the completed Exercise Program Self Certification Form (commencement and finish date); and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p><p align=""justify"">All supporting evidence, including the completed Exercise Program Self Certification Form must be kept in the patient&apos;s medical records.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted for the purposes of administering this restriction can be found on the Services Australia website at www.servicesaustralia.gov.au</p> <p align=""justify"">For details on the appropriate minimum exercise program that will be accepted for the purposes of administering this restriction, please refer to the Services Australia website at www.servicesaustralia.gov.au</p>","N","N","Y","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14674_14667_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","14667","14674","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 18 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 18 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14678_9431_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","9431","14678","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14678_N","null","null","null","null","null","<p align=""justify"">This drug is not PBS-subsidised for prophylaxis of malaria.</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"14681_14683_R","First continuing treatment","STREAMLINED","14683","14681","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14682_14701_R","Subsequent continuing treatment","STREAMLINED","14701","14682","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14684_9625_R","Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","9625","14684","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 18 to 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 18 to 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 18 to 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 18 to 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14685_14659_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","14659","14685","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted for the purposes of administering this restriction can be found on the Services Australia website at www.servicesaustralia.gov.au</p> <p align=""justify"">For details on the appropriate minimum exercise program that will be accepted for the purposes of administering this restriction, please refer to the Services Australia website at www.servicesaustralia.gov.au</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-12-01","Y","4708"
"14687_14715_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","14715","14687","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14688_14662_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","14662","14688","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-12-01","Y","4708"
"14688_C","null","null","null","null","null","<p align=""justify"">Leflunomide is a category X drug and must not be given to pregnant women. Pregnancy should be avoided for two years after cessation of therapy, unless special wash-out procedures are carried out.</p>","N","Y","N","null","null","N","2015-06-01","N","4708"
"14691_14705_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","14705","14691","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14693_14672_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","14672","14693","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14694_14707_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","14707","14694","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 18 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 18 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14695_14692_R","Continuing treatment","AUTHORITY_REQUIRED","14692","14695","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-12-01","Y","4708"
"14699_12174_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","12174","14699","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14700_14656_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","14656","14700","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-12-01","Y","4708"
"14700_N","null","null","null","null","null","<p align=""justify"">Valaciclovir 500 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.</p>","Y","N","N","null","null","N","2015-06-01","N","4708"
"14702_14686_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","14686","14702","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2023-12-01","Y","4708"
"14704_14689_R","First continuing treatment","STREAMLINED","14689","14704","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14708_14708_R","null","STREAMLINED","14708","14708","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced, metastatic or recurrent biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer)</p><br/><p>Patient must have either of the following at treatment initiation: (i) locally advanced biliary tract cancer that is untreated with systemic anti-cancer therapy in the unresectable setting, (ii) metastatic biliary tract cancer that is untreated with systemic anti-cancer therapy in the metastatic setting; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be/have been initiated with both: (i) gemcitabine, (ii) cisplatin (refer to Product Information of gemcitabine and cisplatin for dosing information); AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced, metastatic or recurrent biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer)</p><br/><p>Patient must have either of the following at treatment initiation: (i) locally advanced biliary tract cancer that is untreated with systemic anti-cancer therapy in the unresectable setting, (ii) metastatic biliary tract cancer that is untreated with systemic anti-cancer therapy in the metastatic setting; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be/have been initiated with both: (i) gemcitabine, (ii) cisplatin (refer to Product Information of gemcitabine and cisplatin for dosing information); AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14719_14673_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","14673","14719","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14725_14718_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","14718","14725","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 18 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Details of the NSAIDs trialled, their doses and duration of treatment must be provided at the time of application.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the reason a higher dose cannot be used must be provided.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be provided.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, details of the nature and severity of this intolerance must be provided.</p> <p align=""justify"">All relevant details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the reason this criterion cannot be satisfied must be provided at the time of application.</p> <p align=""justify"">The following must be provided at the time of application:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) details of the completed Exercise Program Self Certification Form (commencement and finish date); and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p><p align=""justify"">All supporting evidence, including the completed Exercise Program Self Certification Form must be kept in the patient&apos;s medical records.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 18 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Details of the NSAIDs trialled, their doses and duration of treatment must be provided at the time of application.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the reason a higher dose cannot be used must be provided.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be provided.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, details of the nature and severity of this intolerance must be provided.</p> <p align=""justify"">All relevant details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the reason this criterion cannot be satisfied must be provided at the time of application.</p> <p align=""justify"">The following must be provided at the time of application:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) details of the completed Exercise Program Self Certification Form (commencement and finish date); and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p><p align=""justify"">All supporting evidence, including the completed Exercise Program Self Certification Form must be kept in the patient&apos;s medical records.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted for the purposes of administering this restriction can be found on the Services Australia website at www.servicesaustralia.gov.au</p> <p align=""justify"">For details on the appropriate minimum exercise program that will be accepted for the purposes of administering this restriction, please refer to the Services Australia website at www.servicesaustralia.gov.au</p>","N","N","Y","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14726_N","null","null","null","null","null","<p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). </p>","Y","N","Y","null","null","N","2015-07-01","N","4708"
"14727_14727_R","null","STREAMLINED","14727","14727","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage II or Stage III triple negative breast cancer</p><br/><p>The treatment must be initiated in combination with neoadjuvant chemotherapy; AND</p> <p>The condition must not have progressed/recurred whilst on treatment with this drug; AND</p> <p>Patient must not be undergoing treatment with this drug beyond 52 cumulative weeks under this restriction; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 4 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage II or Stage III triple negative breast cancer</p><br/><p>The treatment must be initiated in combination with neoadjuvant chemotherapy; AND</p> <p>The condition must not have progressed/recurred whilst on treatment with this drug; AND</p> <p>Patient must not be undergoing treatment with this drug beyond 52 cumulative weeks under this restriction; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 4 repeat prescriptions.</p>","N","N","N","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14729_14729_R","null","STREAMLINED","14729","14729","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adjuvant management of breast cancer</p><br/><p>Patient must be post-menopausal; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adjuvant management of breast cancer</p><br/><p>Patient must be post-menopausal; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months.</p>","N","N","N","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14735_14735_R","null","STREAMLINED","14735","14735","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adjuvant management of breast cancer</p><br/><p>Patient must be post-menopausal; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adjuvant management of breast cancer</p><br/><p>Patient must be post-menopausal; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months.</p>","N","N","N","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14738_14723_R","Subsequent continuing treatment","STREAMLINED","14723","14738","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14739_14671_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","14671","14739","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2023-12-01","N","4708"
"14748_14748_R","Balance of Supply - maintenance doses","AUTHORITY_REQUIRED","14748","14748","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Balance of Supply - maintenance doses</p><br/><p>Patient must have received PBS-subsidised loading dose of ravulizumab for this condition for this current treatment phase; AND</p> <p>Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND</p> <p>Patient must have received insufficient therapy to complete the maximum allowable treatment under their specified treatment phase; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the relevant treatment phase; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">ADAMTS-13 activity result must have been submitted to Services Australia. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial treatment, ADAMTS-13 activity must have been measured 7-10 days following the last plasma exchange or infusion and must have been submitted to Services Australia within 13 days of commencement of ravulizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay must also have been provided to Services Australia.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Balance of Supply - maintenance doses</p><br/><p>Patient must have received PBS-subsidised loading dose of ravulizumab for this condition for this current treatment phase; AND</p> <p>Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND</p> <p>Patient must have received insufficient therapy to complete the maximum allowable treatment under their specified treatment phase; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the relevant treatment phase; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">ADAMTS-13 activity result must have been submitted to Services Australia. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial treatment, ADAMTS-13 activity must have been measured 7-10 days following the last plasma exchange or infusion and must have been submitted to Services Australia within 13 days of commencement of ravulizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay must also have been provided to Services Australia.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 8 weeks of treatment and up to 2 repeats, according to the specified dosage in the approved Product Information (PI). With 2 repeat prescriptions, this treatment phase listing intends to provide approximately 24 weeks of treatment.</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p> <p align=""justify"">Services Australia will contact the prescriber by telephone after a written application has been submitted.</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","Y","4708"
"14750_14750_R","Recommencement - Balance of Supply","AUTHORITY_REQUIRED","14750","14750","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Recommencement - Balance of Supply</p><br/><p>Patient must have previously received PBS-subsidised eculizumab under the ''Recommencement of treatment'' restriction for this condition; AND</p> <p>Patient must not receive more than 20 weeks supply under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Recommencement - Balance of Supply</p><br/><p>Patient must have previously received PBS-subsidised eculizumab under the ''Recommencement of treatment'' restriction for this condition; AND</p> <p>Patient must not receive more than 20 weeks supply under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 4 weeks and up to 4 repeats, according to the specified dosage in the approved Product Information (PI).</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","Y","4708"
"14751_14792_R","Initial treatment - Balance of Supply","AUTHORITY_REQUIRED","14792","14751","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Initial treatment - Balance of Supply</p><br/><p>Patient must have received PBS-subsidised initial supply of eculizumab for this condition; AND</p> <p>Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND</p> <p>Patient must not receive more than 20 weeks supply under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">ADAMTS-13 activity result must have been submitted to Services Australia. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial treatment, ADAMTS-13 activity must have been measured 7-10 days following the last plasma exchange or infusion, and must have been submitted to Services Australia within 27 days of commencement of eculizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay must also have been provided to Services Australia.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Initial treatment - Balance of Supply</p><br/><p>Patient must have received PBS-subsidised initial supply of eculizumab for this condition; AND</p> <p>Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND</p> <p>Patient must not receive more than 20 weeks supply under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">ADAMTS-13 activity result must have been submitted to Services Australia. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial treatment, ADAMTS-13 activity must have been measured 7-10 days following the last plasma exchange or infusion, and must have been submitted to Services Australia within 27 days of commencement of eculizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay must also have been provided to Services Australia.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 4 weeks and up to 4 repeats, according to the specified dosage in the approved Product Information (PI).</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","Y","4708"
"14752_14754_R","Continuing treatment","AUTHORITY_REQUIRED","14754","14752","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised eculizumab under the initial treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the initial treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing treatment phase for this condition; AND</p> <p>Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab for this condition; AND</p> <p>Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must not receive more than 80 weeks of eculizumab treatment in total under this restriction; or</p> <p>Patient must not receive more than 104 weeks supply of a C5 inhibitor under the initial and continuing treatment restrictions if they had switched C5 inhibitors during the course of initial and continuing treatment; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) A completed authority prescription form(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS, if applicable;</p><p align=""justify"">(6) A history of kidney transplant if applicable (especially if required due to aHUS);</p><p align=""justify"">(7) An inclusion of the individual consequences of recurrent disease, if applicable;</p><p align=""justify"">(8) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;</p><p align=""justify"">(9) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(10) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p/><p align=""justify"">This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab. </p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised eculizumab under the initial treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the initial treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing treatment phase for this condition; AND</p> <p>Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab for this condition; AND</p> <p>Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must not receive more than 80 weeks of eculizumab treatment in total under this restriction; or</p> <p>Patient must not receive more than 104 weeks supply of a C5 inhibitor under the initial and continuing treatment restrictions if they had switched C5 inhibitors during the course of initial and continuing treatment; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) A completed authority prescription form(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS, if applicable;</p><p align=""justify"">(6) A history of kidney transplant if applicable (especially if required due to aHUS);</p><p align=""justify"">(7) An inclusion of the individual consequences of recurrent disease, if applicable;</p><p align=""justify"">(8) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;</p><p align=""justify"">(9) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(10) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p/><p align=""justify"">This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab. </p><p/> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 4 weeks and up to 5 repeats, according to the specified dosage in the approved Product Information (PI).</p><p align=""justify"">A maximum of up to 80 weeks of eculizumab treatment (or 104 weeks if switching C5 inhibitors during the course of initial and continuing treatment) is allowed under this restriction, however an authority application must be submitted every 24 weeks under this restriction if patient is deemed eligible.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","Y","4708"
"14753_14753_R","Switch from PBS-subsidised ravulizumab (all phases) - loading dose","AUTHORITY_REQUIRED","14753","14753","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Switch from PBS-subsidised ravulizumab (all phases) - loading dose</p><br/><p>Patient must have previously received PBS-subsidised ravulizumab under the ''Initial treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised ravulizumab under the ''Continuing treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised ravulizumab under the ''Extended continuing treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised ravulizumab under the ''Recommencement of treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised ravulizumab under the ''Continuing recommencement of treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised ravulizumab under the ''Grandfather (transitioning from non-PBS to PBS-subsidised treatment)'' restriction for this condition; AND</p> <p>Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND</p> <p>Patient must not receive more than 24 weeks of C5 inhibitor supply for this current treatment phase under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">The application must indicate the most recent treatment phase that the patient is switching from.</p> <p align=""justify"">For patients who are switching C5 inhibitors, the next application should be sought under the next relevant treatment phase.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) A completed authority prescription form(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Switch from PBS-subsidised ravulizumab (all phases) - loading dose</p><br/><p>Patient must have previously received PBS-subsidised ravulizumab under the ''Initial treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised ravulizumab under the ''Continuing treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised ravulizumab under the ''Extended continuing treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised ravulizumab under the ''Recommencement of treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised ravulizumab under the ''Continuing recommencement of treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised ravulizumab under the ''Grandfather (transitioning from non-PBS to PBS-subsidised treatment)'' restriction for this condition; AND</p> <p>Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND</p> <p>Patient must not receive more than 24 weeks of C5 inhibitor supply for this current treatment phase under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">The application must indicate the most recent treatment phase that the patient is switching from.</p> <p align=""justify"">For patients who are switching C5 inhibitors, the next application should be sought under the next relevant treatment phase.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) A completed authority prescription form(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 24 weeks of treatment, according to the specified dosage in the approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","Y","4708"
"14759_14776_R","Dose titration for relapsed/refractory disease","AUTHORITY_REQUIRED","14776","14759","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL)</p><br/><p>Dose titration for relapsed/refractory disease</p><br/><p>The condition must have relapsed or be refractory to at least one prior therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>Patient must not be undergoing retreatment with this drug where any of: (i) prior treatment of CLL/SLL with this same drug was unable to prevent disease progression; (ii) 24 months of PBS-subsidised treatment has been administered with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL)</p><br/><p>Dose titration for relapsed/refractory disease</p><br/><p>The condition must have relapsed or be refractory to at least one prior therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>Patient must not be undergoing retreatment with this drug where any of: (i) prior treatment of CLL/SLL with this same drug was unable to prevent disease progression; (ii) 24 months of PBS-subsidised treatment has been administered with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","N","4708"
"14763_14799_R","Recommencement of treatment","AUTHORITY_REQUIRED","14799","14763","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have demonstrated treatment response to previous treatment with PBS-subsidised eculizumab for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the recommencement treatment phase for this condition; AND</p> <p>Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must have the following clinical conditions prior to recommencing C5 inhibitor treatment: (i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal; AND (ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L); OR (iii) TMA-related organ impairment including on recent biopsy; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) A completed authority prescription form(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS if applicable;</p><p align=""justify"">(6) A history of multiple episodes of aHUS following the treatment break, if applicable;</p><p align=""justify"">(7) A history of kidney transplant if applicable (especially if required due to aHUS);</p><p align=""justify"">(8) An inclusion of the individual consequences of recurrent disease;</p><p align=""justify"">(9) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy;</p><p align=""justify"">(10) Evidence that the patient has had a treatment response to their previous treatment with eculizumab;</p><p align=""justify"">(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(12) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have demonstrated treatment response to previous treatment with PBS-subsidised eculizumab for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the recommencement treatment phase for this condition; AND</p> <p>Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must have the following clinical conditions prior to recommencing C5 inhibitor treatment: (i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal; AND (ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L); OR (iii) TMA-related organ impairment including on recent biopsy; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) A completed authority prescription form(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS if applicable;</p><p align=""justify"">(6) A history of multiple episodes of aHUS following the treatment break, if applicable;</p><p align=""justify"">(7) A history of kidney transplant if applicable (especially if required due to aHUS);</p><p align=""justify"">(8) An inclusion of the individual consequences of recurrent disease;</p><p align=""justify"">(9) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy;</p><p align=""justify"">(10) Evidence that the patient has had a treatment response to their previous treatment with eculizumab;</p><p align=""justify"">(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(12) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 4 weeks and up to 5 repeats, according to the specified dosage in the approved Product Information (PI).</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p> <p align=""justify"">A raise in LDH alone is not a sufficient reason to recommence a C5 inhibitor, but thrombocytopenia with one marker of haemolysis (such as raised LDH, presence of schistocytes, or low/absence of haptoglobin) is an accepted reason to consider recommencement of C5 inhibitor treatment.</p> <p align=""justify"">Kidney transplantation/dialysis is not a contraindication to recommencement of C5 inhibitor treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","Y","4708"
"14771_14770_R","Initial treatment - 3 weekly treatment regimen","AUTHORITY_REQUIRED","14770","14771","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Initial treatment - 3 weekly treatment regimen</p><br/><p>The treatment must be in addition to complete surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Initial treatment - 3 weekly treatment regimen</p><br/><p>The treatment must be in addition to complete surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised).</p> <p align=""justify"">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p> <p align=""justify"">Commencing treatment within 12 weeks of complete resection means either 12 weeks after resection or 12 weeks prior to resection.</p><p align=""justify"">Where non-PBS-subsidised supply has occurred, the total amount of PBS-subsidised supply is intended to be the balance of 18 doses less the number of non-PBS-subsidised doses.</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","N","4708"
"14772_14786_R","Continuing treatment - 3 weekly treatment regimen","AUTHORITY_REQUIRED","14786","14772","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>Patient must be undergoing continuing PBS-subsidised treatment commenced through an ''Initial treatment'' listing; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>Patient must be undergoing continuing PBS-subsidised treatment commenced through an ''Initial treatment'' listing; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised).</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","N","4708"
"14774_14801_R","Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) - balance of supply","AUTHORITY_REQUIRED","14801","14774","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-01-01","N","4708"
"14782_14781_R","Initial treatment","AUTHORITY_REQUIRED","14781","14782","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Initial treatment</p><br/><p>Patient must have active and progressing thrombotic microangiopathy (TMA) caused by aHUS; AND</p> <p>Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample taken prior to plasma exchange or infusion; or, if ADAMTS-13 activity was not collected prior to plasma exchange or infusion, patient must have platelet counts of greater than 30x10^9/L and a serum creatinine of greater than 150 mol/L; AND</p> <p>Patient must have a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days; AND</p> <p>Patient must have clinical features of active organ damage or impairment; AND</p> <p>Patient must not receive more than 4 weeks of treatment under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">Evidence of active and progressing TMA is defined by the following:</p><p align=""justify"">(1) a platelet count of less than 150x10^9/L; and evidence of two of the following:</p><p align=""justify"">(i) presence of schistocytes on blood film;</p><p align=""justify"">(ii) low or absent haptoglobin;</p><p align=""justify"">(iii) lactate dehydrogenase (LDH) above normal range;</p><p align=""justify"">OR</p><p align=""justify"">(2) in recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA;</p><p align=""justify"">AND</p><p align=""justify"">(3) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:</p><p align=""justify"">(a) kidney impairment as demonstrated by one of the following:</p><p align=""justify"">(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or</p><p align=""justify"">(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment; or</p><p align=""justify"">(iii) a sCr of greater than the age-appropriate ULN in paediatric patients; or</p><p align=""justify"">(iv) a renal biopsy consistent with aHUS;</p><p align=""justify"">(b) onset of TMA-related neurological impairment;</p><p align=""justify"">(c) onset of TMA-related cardiac impairment;</p><p align=""justify"">(d) onset of TMA-related gastrointestinal impairment;</p><p align=""justify"">(e) onset of TMA-related pulmonary impairment.</p><p align=""justify"">Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised eculizumab (where possible), and should be supported by objective clinical measures. The prescriber&apos;s cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) A completed authority prescription form(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A detailed cover letter from the prescriber;</p><p align=""justify"">(4) A measurement of body weight at the time of application;</p><p align=""justify"">(5) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay;</p><p align=""justify"">(6) In the case that a sample for ADAMTS-13 assay was not collected prior to plasma exchange or infusion, measurement of ADAMTS-13 activity must be taken 7-10 days following the last plasma exchange or infusion. The ADAMTS-13 result must be submitted to Services Australia within 27 days of commencement of eculizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised eculizumab treatment, under Initial treatment - Balance of Supply;</p><p align=""justify"">(7) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days;</p><p align=""justify"">(8) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within 4 weeks of application;</p><p align=""justify"">(9) For all patients, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Initial treatment</p><br/><p>Patient must have active and progressing thrombotic microangiopathy (TMA) caused by aHUS; AND</p> <p>Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample taken prior to plasma exchange or infusion; or, if ADAMTS-13 activity was not collected prior to plasma exchange or infusion, patient must have platelet counts of greater than 30x10^9/L and a serum creatinine of greater than 150 mol/L; AND</p> <p>Patient must have a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days; AND</p> <p>Patient must have clinical features of active organ damage or impairment; AND</p> <p>Patient must not receive more than 4 weeks of treatment under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">Evidence of active and progressing TMA is defined by the following:</p><p align=""justify"">(1) a platelet count of less than 150x10^9/L; and evidence of two of the following:</p><p align=""justify"">(i) presence of schistocytes on blood film;</p><p align=""justify"">(ii) low or absent haptoglobin;</p><p align=""justify"">(iii) lactate dehydrogenase (LDH) above normal range;</p><p align=""justify"">OR</p><p align=""justify"">(2) in recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA;</p><p align=""justify"">AND</p><p align=""justify"">(3) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:</p><p align=""justify"">(a) kidney impairment as demonstrated by one of the following:</p><p align=""justify"">(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or</p><p align=""justify"">(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment; or</p><p align=""justify"">(iii) a sCr of greater than the age-appropriate ULN in paediatric patients; or</p><p align=""justify"">(iv) a renal biopsy consistent with aHUS;</p><p align=""justify"">(b) onset of TMA-related neurological impairment;</p><p align=""justify"">(c) onset of TMA-related cardiac impairment;</p><p align=""justify"">(d) onset of TMA-related gastrointestinal impairment;</p><p align=""justify"">(e) onset of TMA-related pulmonary impairment.</p><p align=""justify"">Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised eculizumab (where possible), and should be supported by objective clinical measures. The prescriber&apos;s cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) A completed authority prescription form(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A detailed cover letter from the prescriber;</p><p align=""justify"">(4) A measurement of body weight at the time of application;</p><p align=""justify"">(5) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay;</p><p align=""justify"">(6) In the case that a sample for ADAMTS-13 assay was not collected prior to plasma exchange or infusion, measurement of ADAMTS-13 activity must be taken 7-10 days following the last plasma exchange or infusion. The ADAMTS-13 result must be submitted to Services Australia within 27 days of commencement of eculizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised eculizumab treatment, under Initial treatment - Balance of Supply;</p><p align=""justify"">(7) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days;</p><p align=""justify"">(8) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within 4 weeks of application;</p><p align=""justify"">(9) For all patients, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for four weeks of treatment, according to the specified dosage in the approved Product Information (PI).</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p> <p align=""justify"">The Authority application should be accompanied by a cover letter from the prescriber, providing complete details on:</p><p align=""justify"">a) Presenting clinical features, including history, acute treatment and medications;</p><p align=""justify"">b) Results of testing for genetic mutations (if available);</p><p align=""justify"">c) Family history of aHUS, especially in first-degree relatives;</p><p align=""justify"">d) Patient&apos;s prior history of episodes of active and progressing TMA caused by aHUS;</p><p align=""justify"">e) Exclusion of alternative causes of TMA;</p><p align=""justify"">f) History of renal or other organ transplant (if any);</p><p align=""justify"">g) Any other matters considered relevant by the prescriber.</p><p align=""justify"">In cases where there are discordant results (for example, an equivocal biopsy result in the absence of objective evidence of haemolysis) the cover letter should articulate the prescriber&apos;s interpretation of the clinical data and how a diagnosis of aHUS is supported by the available evidence.</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","Y","4708"
"14790_14761_R","Initial subsequent-line maintenance therapy (BRCA1/2 gene mutation)","AUTHORITY_REQUIRED","14761","14790","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial subsequent-line maintenance therapy (BRCA1/2 gene mutation)</p><br/><p>The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND</p> <p>The condition must be platinum sensitive; AND</p> <p>Patient must have received at least two previous platinum-containing regimens; AND</p> <p>Patient must have relapsed following a previous platinum-containing regimen; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Platinum sensitivity is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial subsequent-line maintenance therapy (BRCA1/2 gene mutation)</p><br/><p>The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND</p> <p>The condition must be platinum sensitive; AND</p> <p>Patient must have received at least two previous platinum-containing regimens; AND</p> <p>Patient must have relapsed following a previous platinum-containing regimen; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Platinum sensitivity is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","N","4708"
"14794_14793_R","Continuing recommencement of treatment","AUTHORITY_REQUIRED","14793","14794","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Continuing recommencement of treatment</p><br/><p>Patient must have received PBS-subsidised eculizumab under the recommencement of treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the recommencement treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing recommencement of treatment phase for this condition; AND</p> <p>Patient must have demonstrated ongoing treatment response to ''Recommencement of treatment'' with a C5 inhibitor for this condition; AND</p> <p>Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must not receive more than 24 weeks of treatment with eculizumab per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) A completed authority prescription form(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS, if applicable;</p><p align=""justify"">(6) A history of multiple episodes of aHUS before recommencing eculizumab treatment, if applicable;</p><p align=""justify"">(7) A history of kidney transplant if applicable (especially if required due to aHUS);</p><p align=""justify"">(8) An inclusion of the individual consequences of recurrent disease, if applicable;</p><p align=""justify"">(9) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;</p><p align=""justify"">(10) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(11) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p/><p align=""justify"">This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab. </p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Continuing recommencement of treatment</p><br/><p>Patient must have received PBS-subsidised eculizumab under the recommencement of treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the recommencement treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing recommencement of treatment phase for this condition; AND</p> <p>Patient must have demonstrated ongoing treatment response to ''Recommencement of treatment'' with a C5 inhibitor for this condition; AND</p> <p>Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must not receive more than 24 weeks of treatment with eculizumab per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) A completed authority prescription form(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS, if applicable;</p><p align=""justify"">(6) A history of multiple episodes of aHUS before recommencing eculizumab treatment, if applicable;</p><p align=""justify"">(7) A history of kidney transplant if applicable (especially if required due to aHUS);</p><p align=""justify"">(8) An inclusion of the individual consequences of recurrent disease, if applicable;</p><p align=""justify"">(9) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;</p><p align=""justify"">(10) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(11) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p/><p align=""justify"">This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab. </p><p/> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 4 weeks and up to 5 repeats, according to the specified dosage in the approved Product Information (PI).</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","Y","4708"
"14798_14805_R","Extended Continuing treatment","AUTHORITY_REQUIRED","14805","14798","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Extended Continuing treatment</p><br/><p>Patient must have received PBS-subsidised eculizumab under the continuing treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the extended continuing treatment phase for this condition; AND</p> <p>Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab for this condition; AND</p> <p>Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40% on current objective measurement; or</p> <p>Patient must have severe TMA-related neurological impairment; or</p> <p>Patient must have severe TMA-related gastrointestinal impairment; or</p> <p>Patient must have severe TMA-related pulmonary impairment on current objective measurement; or</p> <p>Patient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 mL/min); or</p> <p>Patient must have a high risk of aHUS recurrence in the short term in the absence of continued treatment with eculizumab; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) A completed authority prescription form(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS, if applicable;</p><p align=""justify"">(6) A history of multiple episodes of aHUS before commencing eculizumab treatment, if applicable;</p><p align=""justify"">(7) A history of kidney transplant, if applicable (especially if required due to aHUS);</p><p align=""justify"">(8) An inclusion of the individual consequences of recurrent disease;</p><p align=""justify"">(9) A supporting statement with clinical evidence of severe TMA-related cardiomyopathy (including current LVEF result), neurological impairment, gastrointestinal impairment or pulmonary impairment;</p><p align=""justify"">(10) Evidence that the patient has had a treatment response including haematological results of no more than 4 weeks old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 4 weeks old at the time of application;</p><p align=""justify"">(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(12) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p/><p align=""justify"">This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab. </p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Extended Continuing treatment</p><br/><p>Patient must have received PBS-subsidised eculizumab under the continuing treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the extended continuing treatment phase for this condition; AND</p> <p>Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab for this condition; AND</p> <p>Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40% on current objective measurement; or</p> <p>Patient must have severe TMA-related neurological impairment; or</p> <p>Patient must have severe TMA-related gastrointestinal impairment; or</p> <p>Patient must have severe TMA-related pulmonary impairment on current objective measurement; or</p> <p>Patient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 mL/min); or</p> <p>Patient must have a high risk of aHUS recurrence in the short term in the absence of continued treatment with eculizumab; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) A completed authority prescription form(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS, if applicable;</p><p align=""justify"">(6) A history of multiple episodes of aHUS before commencing eculizumab treatment, if applicable;</p><p align=""justify"">(7) A history of kidney transplant, if applicable (especially if required due to aHUS);</p><p align=""justify"">(8) An inclusion of the individual consequences of recurrent disease;</p><p align=""justify"">(9) A supporting statement with clinical evidence of severe TMA-related cardiomyopathy (including current LVEF result), neurological impairment, gastrointestinal impairment or pulmonary impairment;</p><p align=""justify"">(10) Evidence that the patient has had a treatment response including haematological results of no more than 4 weeks old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 4 weeks old at the time of application;</p><p align=""justify"">(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(12) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p/><p align=""justify"">This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab. </p><p/> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 4 weeks and up to 5 repeats, according to the specified dosage in the approved Product Information (PI).</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","Y","4708"
"14804_14741_R","Initial first-line maintenance therapy (BRCA1/2 gene mutation)","AUTHORITY_REQUIRED","14741","14804","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial first-line maintenance therapy (BRCA1/2 gene mutation)</p><br/><p>The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug class for the first time; or</p> <p>Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial first-line maintenance therapy (BRCA1/2 gene mutation)</p><br/><p>The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug class for the first time; or</p> <p>Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.</p>","N","N","N","IMMEDIATE","ALL","N","2024-01-01","N","4708"
"14807_N","null","null","null","null","null","<p/><p align=""justify""> For prescribing in accordance with Optometry Board of Australia guidelines.</p><p/>","Y","N","N","null","null","N","2015-07-01","N","4708"
"14814_14813_R","Initial treatment - day 1","AUTHORITY_REQUIRED","14813","14814","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable or metastatic) uveal melanoma</p><br/><p>Initial treatment - day 1</p><br/><p>Patient must have HLA-A*02:01-positive disease; AND</p> <p>Patient must have uveal melanoma that has been confirmed either (i) histologically, (ii) cytologically; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received prior systemic therapy for metastatic disease; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">Positive HLA-A*02:01 assessment must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable or metastatic) uveal melanoma</p><br/><p>Initial treatment - day 1</p><br/><p>Patient must have HLA-A*02:01-positive disease; AND</p> <p>Patient must have uveal melanoma that has been confirmed either (i) histologically, (ii) cytologically; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received prior systemic therapy for metastatic disease; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">Positive HLA-A*02:01 assessment must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-02-01","N","4708"
"14824_14825_R","Initial treatment - day 15","STREAMLINED","14825","14824","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable or metastatic) uveal melanoma</p><br/><p>Initial treatment - day 15</p><br/><p>Patient must have HLA-A*02:01-positive disease; AND</p> <p>Patient must have previously received PBS-subsidised initial day 8 treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">Positive HLA-A*02:01 assessment must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable or metastatic) uveal melanoma</p><br/><p>Initial treatment - day 15</p><br/><p>Patient must have HLA-A*02:01-positive disease; AND</p> <p>Patient must have previously received PBS-subsidised initial day 8 treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">Positive HLA-A*02:01 assessment must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-02-01","N","4708"
"14826_14821_R","Initial treatment - day 8","STREAMLINED","14821","14826","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable or metastatic) uveal melanoma</p><br/><p>Initial treatment - day 8</p><br/><p>Patient must have HLA-A*02:01-positive disease; AND</p> <p>Patient must have previously received PBS-subsidised initial day 1 treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">Positive HLA-A*02:01 assessment must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable or metastatic) uveal melanoma</p><br/><p>Initial treatment - day 8</p><br/><p>Patient must have HLA-A*02:01-positive disease; AND</p> <p>Patient must have previously received PBS-subsidised initial day 1 treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">Positive HLA-A*02:01 assessment must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-02-01","N","4708"
"14835_14898_R","null","STREAMLINED","14898","14835","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14836_14993_R","null","STREAMLINED","14993","14836","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14840_15009_R","null","AUTHORITY_REQUIRED","15009","14840","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14845_15012_R","null","STREAMLINED","15012","14845","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cranial diabetes insipidus</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cranial diabetes insipidus</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14846_14972_R","null","STREAMLINED","14972","14846","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Patient must be refractory to an enuresis alarm.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">No more than twice the maximum quantity will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Patient must be refractory to an enuresis alarm.</p> <p align=""justify"">Not to be used in preference to enuresis alarms.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">No more than twice the maximum quantity will be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2024-03-01","N","4708"
"14857_N","null","null","null","null","null","<p align=""justify"">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"14866_14956_R","null","AUTHORITY_REQUIRED","14956","14866","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constitutional delay of growth or puberty</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constitutional delay of growth or puberty</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14867_14912_R","null","AUTHORITY_REQUIRED","14912","14867","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must not have an established pituitary or testicular disorder; AND</p> <p>The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs; AND</p> <p>Patient must be aged 40 years or older; AND</p> <p>Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">Androgen deficiency is defined as:</p><p align=""justify"">(i) testosterone level of less than 6 nmol per litre; OR</p><p align=""justify"">(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).</p><p align=""justify"">Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.</p> <p>The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must not have an established pituitary or testicular disorder; AND</p> <p>The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs; AND</p> <p>Patient must be aged 40 years or older; AND</p> <p>Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">Androgen deficiency is defined as:</p><p align=""justify"">(i) testosterone level of less than 6 nmol per litre; OR</p><p align=""justify"">(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).</p><p align=""justify"">Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.</p> <p>The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14869_14914_R","null","RESTRICTED","14914","14869","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p> <p>Acromegaly</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14870_14913_R","null","AUTHORITY_REQUIRED","14913","14870","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Micropenis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Micropenis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14871_15006_R","null","RESTRICTED","15006","14871","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Detrusor overactivity</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be unable to tolerate oral oxybutynin; or</p> <p>Patient must be unable to swallow oral oxybutynin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Detrusor overactivity</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be unable to tolerate oral oxybutynin; or</p> <p>Patient must be unable to swallow oral oxybutynin.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14873_14922_R","null","STREAMLINED","14922","14873","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14876_C","null","null","null","null","null","<p align=""justify"">Episodes of sudden onset of sleep without warning, during activity, have been reported with this drug.</p>","N","Y","N","null","null","N","2015-07-01","N","4708"
"14897_15032_R","null","STREAMLINED","15032","14897","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14917_14915_R","null","RESTRICTED","14915","14917","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Detrusor overactivity</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Detrusor overactivity</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14919_15015_R","null","AUTHORITY_REQUIRED","15015","14919","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have an established pituitary or testicular disorder; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have an established pituitary or testicular disorder; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14920_14921_R","null","STREAMLINED","14921","14920","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial hypophosphataemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial hypophosphataemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14940_14895_R","null","RESTRICTED","14895","14940","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Breast cancer</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be hormone receptor positive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Breast cancer</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be hormone receptor positive.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14958_14918_R","null","RESTRICTED","14918","14958","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be one in whom surgery is not indicated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be one in whom surgery is not indicated.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14960_14983_R","null","RESTRICTED","14983","14960","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have had radiotherapy for this condition with incomplete resolution.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have had radiotherapy for this condition with incomplete resolution.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14961_14955_R","null","AUTHORITY_REQUIRED","14955","14961","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pubertal induction</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pubertal induction</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14968_14970_R","null","AUTHORITY_REQUIRED","14970","14968","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Drug interactions occurring with all of the base-priced drugs</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Drug interactions occurring with all of the base-priced drugs</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14971_15035_R","null","STREAMLINED","15035","14971","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p> <p align=""justify"">Fosamax Plus provides a supplemental intake of vitamin D. The amount of colecalciferol present in Fosamax Plus is not sufficient to use as the sole treatment for correction of vitamin D deficiency.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14979_15043_R","null","RESTRICTED","15043","14979","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be one in whom surgery is not indicated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p> <p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be one in whom surgery is not indicated.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14980_14981_R","null","RESTRICTED","14981","14980","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have had surgery for this condition with incomplete resolution.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p> <p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have had surgery for this condition with incomplete resolution.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14985_14874_R","null","STREAMLINED","14874","14985","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypophosphataemic rickets</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypophosphataemic rickets</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14986_14962_R","null","STREAMLINED","14962","14986","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vitamin D-resistant rickets</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vitamin D-resistant rickets</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14995_14969_R","null","AUTHORITY_REQUIRED","14969","14995","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adverse effects occurring with all of the base-priced drugs</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adverse effects occurring with all of the base-priced drugs</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14996_15024_R","null","STREAMLINED","15024","14996","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p> <p align=""justify"">Fosamax Plus provides a supplemental intake of vitamin D. The amount of colecalciferol present in Fosamax Plus is not sufficient to use as the sole treatment for correction of vitamin D deficiency.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"14998_14947_R","null","RESTRICTED","14947","14998","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent streptococcal infections (including rheumatic fever)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be for prophylaxis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent streptococcal infections (including rheumatic fever)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be for prophylaxis.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"15003_15017_R","null","RESTRICTED","15017","15003","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have had radiotherapy for this condition with incomplete resolution.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p> <p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have had radiotherapy for this condition with incomplete resolution.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"15010_15011_R","null","STREAMLINED","15011","15010","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p> <p align=""justify"">Fosamax Plus provides a supplemental intake of vitamin D. The amount of colecalciferol present in Fosamax Plus is not sufficient to use as the sole treatment for correction of vitamin D deficiency.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"15013_14842_R","null","STREAMLINED","14842","15013","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Patient must be one in whom an enuresis alarm is contraindicated.</p> <p align=""justify"">The reason that an enuresis alarm is contraindicated must be documented in the patient&apos;s medical records when treatment is initiated</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">No more than twice the maximum quantity will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Patient must be one in whom an enuresis alarm is contraindicated.</p> <p align=""justify"">The reason that an enuresis alarm is contraindicated must be documented in the patient&apos;s medical records when treatment is initiated</p> <p align=""justify"">Not to be used in preference to enuresis alarms.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">No more than twice the maximum quantity will be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2024-03-01","N","4708"
"15016_15028_R","null","RESTRICTED","15028","15016","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p> <p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"15019_15005_R","null","RESTRICTED","15005","15019","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have had surgery for this condition with incomplete resolution.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have had surgery for this condition with incomplete resolution.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"15027_15044_R","null","RESTRICTED","15044","15027","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be one in whom radiotherapy is not indicated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p> <p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be one in whom radiotherapy is not indicated.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"15029_15030_R","null","RESTRICTED","15030","15029","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"15033_14837_R","null","RESTRICTED","14837","15033","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypertension</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must not be for the initiation of anti-hypertensive therapy; AND</p> <p>The condition must be inadequately controlled with concomitant treatment with two of the following: an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypertension</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must not be for the initiation of anti-hypertensive therapy; AND</p> <p>The condition must be inadequately controlled with concomitant treatment with two of the following: an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"15034_14841_R","null","AUTHORITY_REQUIRED","14841","15034","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Drug interactions expected to occur with all of the base-priced drugs</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Drug interactions expected to occur with all of the base-priced drugs</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"15041_14945_R","null","STREAMLINED","14945","15041","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Patient must be refractory to an enuresis alarm.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">No increase in the maximum quantity or number of units may be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Patient must be refractory to an enuresis alarm.</p> <p align=""justify"">Not to be used in preference to enuresis alarms.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">No increase in the maximum quantity or number of units may be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2024-03-01","N","4708"
"15042_15025_R","null","STREAMLINED","15025","15042","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Patient must be one in whom an enuresis alarm is contraindicated.</p> <p align=""justify"">The reason that an enuresis alarm is contraindicated must be documented in the patient&apos;s medical records when treatment is initiated</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">No increase in the maximum quantity or number of units may be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Patient must be one in whom an enuresis alarm is contraindicated.</p> <p align=""justify"">The reason that an enuresis alarm is contraindicated must be documented in the patient&apos;s medical records when treatment is initiated</p> <p align=""justify"">Not to be used in preference to enuresis alarms.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">No increase in the maximum quantity or number of units may be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2024-03-01","N","4708"
"15045_14959_R","null","RESTRICTED","14959","15045","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be one in whom radiotherapy is not indicated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be one in whom radiotherapy is not indicated.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"15048_15047_R","null","STREAMLINED","15047","15048","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"15054_15051_R","null","STREAMLINED","15051","15054","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2024-03-01","N","4708"
"15068_15068_R","null","STREAMLINED","15068","15068","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Patient must be unsuitable for administration of an oral form of methotrexate for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Patient must be unsuitable for administration of an oral form of methotrexate for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15072_15103_R","Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","15103","15072","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p> <p align=""justify"">The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p> <p align=""justify"">The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15074_15137_R","Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","15137","15074","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.</p><p align=""justify"">A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.</p> <p align=""justify"">BASDAI scores and CRP levels must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the BASDAI score; and</p><p align=""justify"">(b) the C-reactive protein (CRP) level.</p> <p align=""justify"">The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.</p><p align=""justify"">State in the application whether a loading dose regimen is intended or not.</p><p align=""justify"">Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant &apos;Balance of supply&apos; listing.</p><p align=""justify"">Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.</p><p align=""justify"">A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.</p> <p align=""justify"">BASDAI scores and CRP levels must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the BASDAI score; and</p><p align=""justify"">(b) the C-reactive protein (CRP) level.</p> <p align=""justify"">The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.</p><p align=""justify"">State in the application whether a loading dose regimen is intended or not.</p><p align=""justify"">Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant &apos;Balance of supply&apos; listing.</p><p align=""justify"">Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15075_15150_R","Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","15150","15075","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p> <p align=""justify"">The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p> <p align=""justify"">The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15086_15135_R","Initial treatment - Initial 2 (Change or re-commencement of treatment after a break of less than 5 years)","AUTHORITY_REQUIRED","15135","15086","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 2 (Change or re-commencement of treatment after a break of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND</p> <p>The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle.</p> <p align=""justify"">An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.</p><p align=""justify"">A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.</p> <p align=""justify"">BASDAI scores and CRP levels must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the BASDAI score; and</p><p align=""justify"">(b) the C-reactive protein (CRP) level.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 2 (Change or re-commencement of treatment after a break of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND</p> <p>The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle.</p> <p align=""justify"">An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.</p><p align=""justify"">A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.</p> <p align=""justify"">BASDAI scores and CRP levels must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the BASDAI score; and</p><p align=""justify"">(b) the C-reactive protein (CRP) level.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15087_15126_R","Initial treatment - Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","15126","15087","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.</p><p align=""justify"">A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.</p> <p align=""justify"">BASDAI scores and CRP levels must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the BASDAI score; and</p><p align=""justify"">(b) the C-reactive protein (CRP) level.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.</p><p align=""justify"">A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.</p> <p align=""justify"">BASDAI scores and CRP levels must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the BASDAI score; and</p><p align=""justify"">(b) the C-reactive protein (CRP) level.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15093_15141_R","Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation)","AUTHORITY_REQUIRED","15141","15093","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation)</p><br/><p>The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND</p> <p>The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; or</p> <p>The condition must have both: (i) been in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug class for the first time; or</p> <p>Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of homologous recombination deficiency (genomic instability) must be derived through a test that has been validated against the Myriad MyChoice HRD assay, which uses a score of 42 or greater as the threshold for HRD (genomic instability) positivity.</p><p align=""justify"">Evidence that BRCA1/2 gene mutations are absent must also be derived through a validated test as described above.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation)</p><br/><p>The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND</p> <p>The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; or</p> <p>The condition must have both: (i) been in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug class for the first time; or</p> <p>Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of homologous recombination deficiency (genomic instability) must be derived through a test that has been validated against the Myriad MyChoice HRD assay, which uses a score of 42 or greater as the threshold for HRD (genomic instability) positivity.</p><p align=""justify"">Evidence that BRCA1/2 gene mutations are absent must also be derived through a validated test as described above.</p>","N","N","N","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15098_15085_R","Continuing treatment","STREAMLINED","15085","15098","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable or metastatic) uveal melanoma</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received inpatient treatment with this drug for this condition in the public hospital setting; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug for this condition if it is no longer determined to be clinically beneficial by the treating clinician.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable or metastatic) uveal melanoma</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received inpatient treatment with this drug for this condition in the public hospital setting; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug for this condition if it is no longer determined to be clinically beneficial by the treating clinician.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.</p>","N","N","N","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15099_15125_R","Continuing treatment","AUTHORITY_REQUIRED","15125","15099","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15113_15095_R","Continuing/maintenance treatment with this drug of either symptomatic Type I, II or IIIa SMA, or, pre-symptomatic SMA (1 or 2 copies of the SMN2 gene)","AUTHORITY_REQUIRED","15095","15113","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment with this drug of either symptomatic Type I, II or IIIa SMA, or, pre-symptomatic SMA (1 or 2 copies of the SMN2 gene)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; AND</p> <p>Patient must not be undergoing treatment through this ''Continuing treatment'' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy; AND</p> <p>Patient must have been 18 years of age or younger at the time of initial treatment with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.</p> <p align=""justify"">The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant &apos;Note&apos; attached to this listing.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment with this drug of either symptomatic Type I, II or IIIa SMA, or, pre-symptomatic SMA (1 or 2 copies of the SMN2 gene)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; AND</p> <p>Patient must not be undergoing treatment through this ''Continuing treatment'' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy; AND</p> <p>Patient must have been 18 years of age or younger at the time of initial treatment with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.</p> <p align=""justify"">The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant &apos;Note&apos; attached to this listing.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","N","N","N","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15119_15140_R","Continuing treatment","AUTHORITY_REQUIRED","15140","15119","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15120_15149_R","Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","15149","15120","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND</p> <p>The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.</p><p align=""justify"">A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.</p> <p align=""justify"">BASDAI scores and CRP levels must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the BASDAI score; and</p><p align=""justify"">(b) the C-reactive protein (CRP) level.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND</p> <p>The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.</p><p align=""justify"">A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.</p> <p align=""justify"">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align=""justify"">(a) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.</p> <p align=""justify"">BASDAI scores and CRP levels must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the BASDAI score; and</p><p align=""justify"">(b) the C-reactive protein (CRP) level.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15123_15112_R","Continuing/maintenance treatment of a patient commenced on this drug under the pre-symptomatic SMA (3 copies of the SMN2 gene) listing","AUTHORITY_REQUIRED","15112","15123","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment of a patient commenced on this drug under the pre-symptomatic SMA (3 copies of the SMN2 gene) listing</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or initiated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Patient must not be undergoing treatment through this ''Continuing treatment'' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be eligible for continuing PBS-subsidised treatment with risdiplam for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must have been 18 years of age or younger at the time of initial treatment with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">In a patient who wishes to switch from PBS-subsidised risdiplam to PBS-subsidised nusinersen for this condition a wash out period may be required.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment of a patient commenced on this drug under the pre-symptomatic SMA (3 copies of the SMN2 gene) listing</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or initiated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Patient must not be undergoing treatment through this ''Continuing treatment'' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be eligible for continuing PBS-subsidised treatment with risdiplam for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must have been 18 years of age or younger at the time of initial treatment with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">In a patient who wishes to switch from PBS-subsidised risdiplam to PBS-subsidised nusinersen for this condition a wash out period may be required.</p>","N","N","N","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15134_15071_R","Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","15071","15134","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>The treatment must not exceed a maximum of 16 weeks duration under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p> <p align=""justify"">The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>The treatment must not exceed a maximum of 16 weeks duration under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p> <p align=""justify"">The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15136_15158_R","Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","15158","15136","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p> <p align=""justify"">The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.</p><p align=""justify"">State in the application whether a loading dose regimen is intended or not.</p><p align=""justify"">Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant &apos;Balance of supply&apos; listing.</p><p align=""justify"">Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p> <p align=""justify"">The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.</p><p align=""justify"">State in the application whether a loading dose regimen is intended or not.</p><p align=""justify"">Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant &apos;Balance of supply&apos; listing.</p><p align=""justify"">Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15136_C","null","null","null","null","null","<p align=""justify"">Naltrexone hydrochloride is contraindicated in patients receiving opioid drugs.</p>","N","Y","N","null","null","N","2015-07-01","N","4708"
"15139_15118_R","null","STREAMLINED","15118","15139","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15143_15063_R","Continuing treatment - 3 weekly treatment regimen","STREAMLINED","15063","15143","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment - 3 weekly treatment regimen</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first.</p>","N","N","N","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15145_15069_R","Continuing/maintenance treatment of either symptomatic Type I, II or IIIa SMA, or of a patient commenced on this drug under the pre-symptomatic SMA (1 or 2 copies of the SMN2 gene) listing","AUTHORITY_REQUIRED","15069","15145","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment of either symptomatic Type I, II or IIIa SMA, or of a patient commenced on this drug under the pre-symptomatic SMA (1 or 2 copies of the SMN2 gene) listing</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or initiated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Patient must not be undergoing treatment through this ''Continuing treatment'' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be eligible for continuing PBS-subsidised treatment with risdiplam for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must have been 18 years of age or younger at the time of initial treatment with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">In a patient who wishes to switch from PBS-subsidised risdiplam to PBS-subsidised nusinersen for this condition a wash out period may be required.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment of either symptomatic Type I, II or IIIa SMA, or of a patient commenced on this drug under the pre-symptomatic SMA (1 or 2 copies of the SMN2 gene) listing</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or initiated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Patient must not be undergoing treatment through this ''Continuing treatment'' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be eligible for continuing PBS-subsidised treatment with risdiplam for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must have been 18 years of age or younger at the time of initial treatment with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">In a patient who wishes to switch from PBS-subsidised risdiplam to PBS-subsidised nusinersen for this condition a wash out period may be required.</p>","N","N","N","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15147_15138_R","null","STREAMLINED","15138","15147","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.</p>","N","N","N","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15156_10436_R","Initial 1 (New patient), Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","10436","15156","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial 1 (New patient), Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial 1 (New patient), Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-04-01","N","4708"
"15171_15171_R","Initial treatment","AUTHORITY_REQUIRED","15171","15171","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe pruritus (itching) associated with chronic kidney disease</p><br/><p>Initial treatment</p><br/><p>Patient must be on optimised haemodialysis; AND</p> <p>Patient must be on haemodialysis for at least 3 months; AND</p> <p>The condition must be confirmed based on both physical examination and patient history to exclude any factors that may be triggering the pruritus; AND</p> <p>Patient must have experienced itch that persists for at least 6 weeks despite best supportive care; AND</p> <p>Patient must have a 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) baseline score of more than 4; AND</p> <p>Patient must not receive more than 12 weeks of treatment under this restriction; AND</p> <p>Must be treated by a nephrologist; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Prescriber must exclude any other causes of pruritus which include any of the following:</p><p align=""justify"">(i) drug/dialysis related (e.g., opioid-related pruritus);</p><p align=""justify"">(ii) drug hypersensitivity or adverse effect; contact dermatitis; allergy;</p><p align=""justify"">(iii) differential diagnoses (e.g., xerosis; infestations; iron deficiency; liver disease; polycythaemia vera/leukemia/lymphoma; hypothyroidism; uncontrolled diabetes).</p> <p align=""justify"">Best supportive care for patients with chronic kidney disease-associated pruritus is not limited to but includes:</p><p align=""justify"">(i) optimisation of dialysis;</p><p align=""justify"">(ii) skin hydration and nutrition (with the use of moisturiser, emollients, barrier creams or oils);</p><p align=""justify"">(iii) patient education on the importance of avoiding or minimising scratching.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug, based on the dry body weight of the patient (in kg), adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). Up to a maximum of 2 repeats will be authorised. No more than 4 doses per week will be authorised even if the number of haemodialysis treatments in a week exceeds 4.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe pruritus (itching) associated with chronic kidney disease</p><br/><p>Initial treatment</p><br/><p>Patient must be on optimised haemodialysis; AND</p> <p>Patient must be on haemodialysis for at least 3 months; AND</p> <p>The condition must be confirmed based on both physical examination and patient history to exclude any factors that may be triggering the pruritus; AND</p> <p>Patient must have experienced itch that persists for at least 6 weeks despite best supportive care; AND</p> <p>Patient must have a 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) baseline score of more than 4; AND</p> <p>Patient must not receive more than 12 weeks of treatment under this restriction; AND</p> <p>Must be treated by a nephrologist; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Prescriber must exclude any other causes of pruritus which include any of the following:</p><p align=""justify"">(i) drug/dialysis related (e.g., opioid-related pruritus);</p><p align=""justify"">(ii) drug hypersensitivity or adverse effect; contact dermatitis; allergy;</p><p align=""justify"">(iii) differential diagnoses (e.g., xerosis; infestations; iron deficiency; liver disease; polycythaemia vera/leukemia/lymphoma; hypothyroidism; uncontrolled diabetes).</p> <p align=""justify"">Best supportive care for patients with chronic kidney disease-associated pruritus is not limited to but includes:</p><p align=""justify"">(i) optimisation of dialysis;</p><p align=""justify"">(ii) skin hydration and nutrition (with the use of moisturiser, emollients, barrier creams or oils);</p><p align=""justify"">(iii) patient education on the importance of avoiding or minimising scratching.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug, based on the dry body weight of the patient (in kg), adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). Up to a maximum of 2 repeats will be authorised. No more than 4 doses per week will be authorised even if the number of haemodialysis treatments in a week exceeds 4.</p>","N","N","N","IMMEDIATE","ALL","N","2024-05-01","N","4708"
"15180_15193_R","null","STREAMLINED","15193","15180","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with radiotherapy being used to treat malignancy; or</p> <p>The condition must be associated with chemotherapy (including methotrexate) being used in the treatment of malignancy and juvenile autoimmune conditions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with radiotherapy being used to treat malignancy; or</p> <p>The condition must be associated with chemotherapy (including methotrexate) being used in the treatment of malignancy and juvenile autoimmune conditions.</p>","N","N","N","IMMEDIATE","ALL","N","2024-05-01","N","4708"
"15183_15163_R","Initial treatment covering the first 6 treatment cycles","STREAMLINED","15163","15183","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Initial treatment covering the first 6 treatment cycles</p><br/><p>Patient must have deficient mismatch repair (dMMR) endometrial cancer, as determined by immunohistochemistry test; AND</p> <p>The condition must be unsuitable for at least one of the following: (i) curative surgical resection, (ii) curative radiotherapy; AND</p> <p>The treatment must be initiated in combination with platinum-containing chemotherapy; AND</p> <p>The condition must be, at treatment initiation with this drug, either: (i) untreated with systemic therapy, (ii) treated with neoadjuvant/adjuvant systemic therapy, but the cancer has recurred or progressed after more than 6 months from the last dose of systemic therapy; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Initial treatment covering the first 6 treatment cycles</p><br/><p>Patient must have deficient mismatch repair (dMMR) endometrial cancer, as determined by immunohistochemistry test; AND</p> <p>The condition must be unsuitable for at least one of the following: (i) curative surgical resection, (ii) curative radiotherapy; AND</p> <p>The treatment must be initiated in combination with platinum-containing chemotherapy; AND</p> <p>The condition must be, at treatment initiation with this drug, either: (i) untreated with systemic therapy, (ii) treated with neoadjuvant/adjuvant systemic therapy, but the cancer has recurred or progressed after more than 6 months from the last dose of systemic therapy; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation.</p>","N","N","N","IMMEDIATE","ALL","N","2024-05-01","N","4708"
"15211_15211_R","Continuing treatment","AUTHORITY_REQUIRED","15211","15211","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe pruritus (itching) associated with chronic kidney disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug including at least a 3-point improvement from baseline in 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) score; AND</p> <p>Must be treated by a nephrologist; or</p> <p>Must be treated by a medical practitioner in consultation with a nephrologist.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug, based on the dry body weight of the patient (in kg), adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). Up to a maximum of 5 repeats will be authorised. No more than 4 doses per week will be authorised even if the number of haemodialysis treatments in a week exceeds 4.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe pruritus (itching) associated with chronic kidney disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug including at least a 3-point improvement from baseline in 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) score; AND</p> <p>Must be treated by a nephrologist; or</p> <p>Must be treated by a medical practitioner in consultation with a nephrologist.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug, based on the dry body weight of the patient (in kg), adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). Up to a maximum of 5 repeats will be authorised. No more than 4 doses per week will be authorised even if the number of haemodialysis treatments in a week exceeds 4.</p>","N","N","N","IMMEDIATE","ALL","N","2024-05-01","N","4708"
"15224_15173_R","Continuing treatment - Second line treatment","AUTHORITY_REQUIRED","15173","15224","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe aplastic anaemia</p><br/><p>Continuing treatment - Second line treatment</p><br/><p>The condition must be severe aplastic anaemia; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction; AND</p> <p>Patient must have demonstrated a response to PBS-subsidised treatment with this drug.</p> <p align=""justify"">Platelet, haemoglobin and neutrophil counts must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Once platelet count is greater than 50 x 10<sup>9</sup>/L, haemoglobin is greater than 100 g/L in the absence of red blood cell (RBC) transfusion, and absolute neutrophil (ANC) is greater than 1 x 10<sup>9</sup>/L for more than 8 weeks, the dose of eltrombopag should be reduced as per the Product Information.</p> <p align=""justify"">For the purposes of this restriction, a response is defined as no longer meeting the criteria for severe aplastic anaemia.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe aplastic anaemia</p><br/><p>Continuing treatment - Second line treatment</p><br/><p>The condition must be severe aplastic anaemia; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction; AND</p> <p>Patient must have demonstrated a response to PBS-subsidised treatment with this drug.</p> <p align=""justify"">Platelet, haemoglobin and neutrophil counts must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Once platelet count is greater than 50 x 10<sup>9</sup>/L, haemoglobin is greater than 100 g/L in the absence of red blood cell (RBC) transfusion, and absolute neutrophil (ANC) is greater than 1 x 10<sup>9</sup>/L for more than 8 weeks, the dose of eltrombopag should be reduced as per the Product Information.</p> <p align=""justify"">For the purposes of this restriction, a response is defined as no longer meeting the criteria for severe aplastic anaemia.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-05-01","N","4708"
"15231_15205_R","Continuing treatment","STREAMLINED","15205","15231","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 36 cumulative months from the first administered dose, once in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 36 cumulative months from the first administered dose, once in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2024-05-01","N","4708"
"15263_15263_R","Subsequent PBS-prescriptions for any GLP-1 receptor agonist","STREAMLINED","15263","15263","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>Subsequent PBS-prescriptions for any GLP-1 receptor agonist</p><br/><p>Patient must not be undergoing concomitant PBS-subsidised treatment for type 2 diabetes mellitus with any of: an SGLT2 inhibitor, a DPP4 inhibitor, another GLP-1 receptor agonist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>Subsequent PBS-prescriptions for any GLP-1 receptor agonist</p><br/><p>Patient must not be undergoing concomitant PBS-subsidised treatment for type 2 diabetes mellitus with any of: an SGLT2 inhibitor, a DPP4 inhibitor, another GLP-1 receptor agonist.</p> <p align=""justify"">Abbreviations used in the restriction are as follows:</p><p align=""justify"">SGLT2 - sodium glucose co-transporter-2 inhibitor (drug names ending in &apos;flozin&apos;)</p><p align=""justify"">DPP4 - dipeptidyl peptidase-4 inhibitor (drug names ending in &apos;gliptin&apos;)</p><p align=""justify"">GLP-1 - glucagon-like peptide-1 receptor agonist</p> <p align=""justify"">Where an SGLT2 inhibitor is being accessed through a PBS indication other than diabetes, the clinical criterion excluding concomitant treatment with an SGLT2 inhibitor is in relation to diabetes mellitus type 2 only.</p>","N","N","N","IMMEDIATE","ALL","N","2024-06-01","N","4708"
"15273_15271_R","Continuing treatment","AUTHORITY_REQUIRED","15271","15273","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic thromboembolic pulmonary hypertension (CTEPH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must demonstrate stable or responding disease; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated in a centre with expertise in the management of CTEPH; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Response to this drug is defined as follows:</p><p align=""justify"">For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease.</p><p align=""justify"">For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease.</p><p align=""justify"">For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease.</p><p align=""justify"">Test requirements to establish response to treatment for continuation of treatment are as follows:</p><p align=""justify"">The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:</p><p align=""justify"">(1) RHC plus ECHO composite assessments plus 6MWT;</p><p align=""justify"">(2) RHC plus ECHO composite assessments;</p><p align=""justify"">(3) RHC composite assessment plus 6MWT;</p><p align=""justify"">(4) ECHO composite assessment plus 6MWT;</p><p align=""justify"">(5) RHC composite assessment only;</p><p align=""justify"">(6) ECHO composite assessment only.</p><p align=""justify"">The results of the same tests as conducted at baseline should be documented in the patient&apos;s medical record with each continuing treatment application (i.e., every 6 months), except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be documented in the patient&apos;s medical records.</p><p align=""justify"">The test results conducted for continuing treatment must be no more than 2 months old at the time of application.</p> <p align=""justify"">The assessment of the patient&apos;s response to the continuing 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.</p> <p align=""justify"">The maximum quantity per prescription must be based on the dosage recommendations in the TGA-approved Product Information and be limited to provide sufficient supply for 1 month of treatment.</p> <p align=""justify"">A maximum of 5 repeats will be authorised.</p> <p align=""justify"">Patients who fail to demonstrate disease stability or improvement to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic thromboembolic pulmonary hypertension (CTEPH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must demonstrate stable or responding disease; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated in a centre with expertise in the management of CTEPH; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Response to this drug is defined as follows:</p><p align=""justify"">For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease.</p><p align=""justify"">For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease.</p><p align=""justify"">For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease.</p><p align=""justify"">Test requirements to establish response to treatment for continuation of treatment are as follows:</p><p align=""justify"">The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:</p><p align=""justify"">(1) RHC plus ECHO composite assessments plus 6MWT;</p><p align=""justify"">(2) RHC plus ECHO composite assessments;</p><p align=""justify"">(3) RHC composite assessment plus 6MWT;</p><p align=""justify"">(4) ECHO composite assessment plus 6MWT;</p><p align=""justify"">(5) RHC composite assessment only;</p><p align=""justify"">(6) ECHO composite assessment only.</p><p align=""justify"">The results of the same tests as conducted at baseline should be documented in the patient&apos;s medical record with each continuing treatment application (i.e., every 6 months), except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be documented in the patient&apos;s medical records.</p><p align=""justify"">The test results conducted for continuing treatment must be no more than 2 months old at the time of application.</p> <p align=""justify"">The assessment of the patient&apos;s response to the continuing 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated.</p> <p align=""justify"">The maximum quantity per prescription must be based on the dosage recommendations in the TGA-approved Product Information and be limited to provide sufficient supply for 1 month of treatment.</p> <p align=""justify"">A maximum of 5 repeats will be authorised.</p> <p align=""justify"">Patients who fail to demonstrate disease stability or improvement to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-06-01","N","4708"
"15277_C","null","null","null","null","null","<p align=""justify"">Contraindications to treatment include known sensitivity to botulinum toxin.</p>","N","Y","N","null","null","N","2015-07-01","N","4708"
"15291_15272_R","Balance of supply","AUTHORITY_REQUIRED","15272","15291","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic thromboembolic pulmonary hypertension (CTEPH)</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete a maximum of 20 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete a maximum of 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 or 24 weeks of treatment available under the above respective restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated in a centre with expertise in the management of CTEPH; AND</p> <p>Patient must be at least 18 years of age.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic thromboembolic pulmonary hypertension (CTEPH)</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete a maximum of 20 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete a maximum of 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 or 24 weeks of treatment available under the above respective restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated in a centre with expertise in the management of CTEPH; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-06-01","N","4708"
"15301_15301_R","First PBS-prescription for this drug","AUTHORITY_REQUIRED","15301","15301","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>First PBS-prescription for this drug</p><br/><p>The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>Patient must not have achieved a clinically meaningful glycaemic response with an SGLT2 inhibitor; or</p> <p>Patient must have a contraindication/intolerance requiring treatment discontinuation of an SGLT2 inhibitor; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment for type 2 diabetes mellitus with any of: an SGLT2 inhibitor, a DPP4 inhibitor, another GLP-1 receptor agonist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>First PBS-prescription for this drug</p><br/><p>The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>Patient must not have achieved a clinically meaningful glycaemic response with an SGLT2 inhibitor; or</p> <p>Patient must have a contraindication/intolerance requiring treatment discontinuation of an SGLT2 inhibitor; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment for type 2 diabetes mellitus with any of: an SGLT2 inhibitor, a DPP4 inhibitor, another GLP-1 receptor agonist.</p> <p align=""justify"">Definition:</p><p align=""justify"">A HbA1c measurement greater than 7% despite treatment with the specified prior therapy/therapies indicates inadequate responsiveness. Where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2-week period indicates inadequate responsiveness.</p><p align=""justify"">Blood glucose monitoring is an alternative to HbA1c measurement where at least one of the following circumstances applies:</p><p align=""justify"">(a) A clinical condition with reduced red blood cell survival (inclusive of haemolytic anaemias, haemoglobinopathies),</p><p align=""justify"">(b) Red cell transfusion within the previous 3 months.</p><p align=""justify"">Document HbA1c measurements (blood glucose measurements where relevant), as well as any intolerances/contraindications in the patient&apos;s medical records.</p> <p align=""justify"">Abbreviations used in the restriction are as follows:</p><p align=""justify"">SGLT2 - sodium glucose co-transporter-2 inhibitor (drug names ending in &apos;flozin&apos;)</p><p align=""justify"">DPP4 - dipeptidyl peptidase-4 inhibitor (drug names ending in &apos;gliptin&apos;)</p><p align=""justify"">GLP-1 - glucagon-like peptide-1 receptor agonist</p> <p align=""justify"">Where an SGLT2 inhibitor is being accessed through a PBS indication other than diabetes, the clinical criterion excluding concomitant treatment with an SGLT2 inhibitor is in relation to diabetes mellitus type 2 only.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 888 333.</p>","N","N","N","IMMEDIATE","ALL","N","2024-06-01","N","4708"
"15312_15290_R","null","RESTRICTED","15290","15312","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-06-01","N","4708"
"15317_N","null","null","null","null","null","<p align=""justify"">Bandage can be left in situ for up to 7 days as per manufacturer&apos;s instructions.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"15321_15321_R","null","RESTRICTED","15321","15321","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p>","N","N","N","IMMEDIATE","ALL","N","2024-06-01","N","4708"
"15327_15303_R","Second and subsequent PBS-subsidised prescriptions for this drug","AUTHORITY_REQUIRED","15303","15327","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Transthyretin amyloid cardiomyopathy</p><br/><p>Second and subsequent PBS-subsidised prescriptions for this drug</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have an estimated glomerular filtration rate (eGFR) greater than 25 mL/minute/1.73 m2; AND</p> <p>The treatment must be ceased where the patient''s heart failure has worsened to persistent New York Heart Association (NYHA) Class III/IV heart failure; AND</p> <p>The treatment must be ceased where the patient has received any of: (i) a heart transplant, (ii) a liver transplant, (iii) an implanted ventricular assist device; AND</p> <p>Must be treated by a medical practitioner who is any of the following: (i) a cardiologist, (ii) a consultant physician with experience in the management of amyloid disorders; this authority application must be sought by the same medical practitioner providing treatment.</p> <p align=""justify"">Confirm whether heart failure has worsened to NYHA Class III/IV since the last authority application (yes/no).</p><p align=""justify"">If &apos;no&apos;, continued PBS subsidy is available.</p><p align=""justify"">If &apos;yes&apos;, continued PBS subsidy is available, but the prescriber must undertake a review of the patient within 3 months to determine whether the worsening heart failure was transient or persistent.</p><p align=""justify"">Where this subsequent clinical review finds that the heart failure persists as NYHA Class III/IV heart failure despite active treatment with this drug, then PBS subsidy is not available.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">If heart failure has worsened to NYHA Class III/IV since the last authority application, no more than 2 repeat prescriptions must be prescribed.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Transthyretin amyloid cardiomyopathy</p><br/><p>Second and subsequent PBS-subsidised prescriptions for this drug</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have an estimated glomerular filtration rate (eGFR) greater than 25 mL/minute/1.73 m2; AND</p> <p>The treatment must be ceased where the patient''s heart failure has worsened to persistent New York Heart Association (NYHA) Class III/IV heart failure; AND</p> <p>The treatment must be ceased where the patient has received any of: (i) a heart transplant, (ii) a liver transplant, (iii) an implanted ventricular assist device; AND</p> <p>Must be treated by a medical practitioner who is any of the following: (i) a cardiologist, (ii) a consultant physician with experience in the management of amyloid disorders; this authority application must be sought by the same medical practitioner providing treatment.</p> <p align=""justify"">Confirm whether heart failure has worsened to NYHA Class III/IV since the last authority application (yes/no).</p><p align=""justify"">If &apos;no&apos;, continued PBS subsidy is available.</p><p align=""justify"">If &apos;yes&apos;, continued PBS subsidy is available, but the prescriber must undertake a review of the patient within 3 months to determine whether the worsening heart failure was transient or persistent.</p><p align=""justify"">Where this subsequent clinical review finds that the heart failure persists as NYHA Class III/IV heart failure despite active treatment with this drug, then PBS subsidy is not available.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">If heart failure has worsened to NYHA Class III/IV since the last authority application, no more than 2 repeat prescriptions must be prescribed.</p>","N","N","Y","IMMEDIATE","ALL","Y","2024-06-01","N","4708"
"15332_15333_R","Initial","AUTHORITY_REQUIRED","15333","15332","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Insomnia</p><br/><p>Initial</p><br/><p>Patient must have Smith-Magenis Syndrome confirmed by genetic testing; AND</p> <p>The condition must be inadequately responsive to sleep hygiene measures, resulting in the patient experiencing a period of at least 12 consecutive weeks of impaired sleep (see definition of impaired sleep below); AND</p> <p>Must be treated by a medical practitioner identifying as at least one of: (i) a paediatrician, (ii) a sleep physician, (iii) neurologist, (iv) a psychiatrist, (v) a developmental specialist (see NOTE); this authority approval is being sought by one of these 5 prescriber types; AND</p> <p>Patient must be at least 2 years of age, but yet to turn 18 years of age, at treatment initiation with this drug.</p> <p align=""justify"">Definition:</p><p align=""justify"">For the purposes of administering this restriction, Smith-Magenis Syndrome is confirmed by the deletion or variation of the retinoic acid induced 1 (RAI1) gene on chromosome 17p11.2</p> <p align=""justify"">Definition:<br/>For the purposes of administering this restriction, impaired sleep is at least one of:<br/>(i) less than 6 hours of continuous sleep on at least 3 occasions over a given 5-day interval; <br/>(ii) taking at least half an hour to fall asleep on at least 3 occasions over a given 5-day interval.</p><p align=""justify"">Prior to seeking authorisation for this pharmaceutical benefit, document the amount of continuous sleep/sleep latency in the patient&apos;s medical records for a period of 2 consecutive weeks, but ensure the impairment has been observed for at least 12 consecutive weeks. The documented values (averages) will form baseline measurements upon which the extent of response to treatment is to be considered under the Continuing treatment listing.</p><p align=""justify"">The observations of continuous sleep/sleep latency may be based on any of the following, including a mix of: patient self-reporting, parental observation, documented medical history, sleep studies conducted by health professionals.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Insomnia</p><br/><p>Initial</p><br/><p>Patient must have Smith-Magenis Syndrome confirmed by genetic testing; AND</p> <p>The condition must be inadequately responsive to sleep hygiene measures, resulting in the patient experiencing a period of at least 12 consecutive weeks of impaired sleep (see definition of impaired sleep below); AND</p> <p>Must be treated by a medical practitioner identifying as at least one of: (i) a paediatrician, (ii) a sleep physician, (iii) neurologist, (iv) a psychiatrist, (v) a developmental specialist (see NOTE); this authority approval is being sought by one of these 5 prescriber types; AND</p> <p>Patient must be at least 2 years of age, but yet to turn 18 years of age, at treatment initiation with this drug.</p> <p align=""justify"">Definition:</p><p align=""justify"">For the purposes of administering this restriction, Smith-Magenis Syndrome is confirmed by the deletion or variation of the retinoic acid induced 1 (RAI1) gene on chromosome 17p11.2</p> <p align=""justify"">Definition:<br/>For the purposes of administering this restriction, impaired sleep is at least one of:<br/>(i) less than 6 hours of continuous sleep on at least 3 occasions over a given 5-day interval; <br/>(ii) taking at least half an hour to fall asleep on at least 3 occasions over a given 5-day interval.</p><p align=""justify"">Prior to seeking authorisation for this pharmaceutical benefit, document the amount of continuous sleep/sleep latency in the patient&apos;s medical records for a period of 2 consecutive weeks, but ensure the impairment has been observed for at least 12 consecutive weeks. The documented values (averages) will form baseline measurements upon which the extent of response to treatment is to be considered under the Continuing treatment listing.</p><p align=""justify"">The observations of continuous sleep/sleep latency may be based on any of the following, including a mix of: patient self-reporting, parental observation, documented medical history, sleep studies conducted by health professionals.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15334_15363_R","Continuing","AUTHORITY_REQUIRED","15363","15334","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Insomnia</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have experienced/maintained a clinically meaningful response (as defined below) to the preceding supply of this drug - document the response improvement in the patient''s medical records; AND</p> <p>The treatment must have commenced between the ages of 2 to 17 years inclusive; AND</p> <p>Must be treated by a medical practitioner identifying as at least one of: (i) a paediatrician, (ii) a sleep physician, (iii) neurologist, (iv) a psychiatrist, (v) a developmental specialist (see NOTE); this authority approval is being sought by one of these 5 prescriber types; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Treatment must cease if a patient is unable to achieve a clinically meaningful response on the maximum dose of melatonin specified in the Product Information.</p> <p align=""justify"">Definition:</p><p align=""justify"">A clinically meaningful response to this drug is defined as at least one of:</p><p align=""justify"">(i) an increase in total sleep time of at least 45 minutes per night on average from baseline;</p><p align=""justify"">(ii) a decrease in the time it takes to fall asleep by at least 15 minutes per night on average from baseline.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Insomnia</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have experienced/maintained a clinically meaningful response (as defined below) to the preceding supply of this drug - document the response improvement in the patient''s medical records; AND</p> <p>The treatment must have commenced between the ages of 2 to 17 years inclusive; AND</p> <p>Must be treated by a medical practitioner identifying as at least one of: (i) a paediatrician, (ii) a sleep physician, (iii) neurologist, (iv) a psychiatrist, (v) a developmental specialist (see NOTE); this authority approval is being sought by one of these 5 prescriber types; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Treatment must cease if a patient is unable to achieve a clinically meaningful response on the maximum dose of melatonin specified in the Product Information.</p> <p align=""justify"">Definition:</p><p align=""justify"">A clinically meaningful response to this drug is defined as at least one of:</p><p align=""justify"">(i) an increase in total sleep time of at least 45 minutes per night on average from baseline;</p><p align=""justify"">(ii) a decrease in the time it takes to fall asleep by at least 15 minutes per night on average from baseline.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15335_15440_R","Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets","AUTHORITY_REQUIRED","15440","15335","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets</p><br/><p>The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND</p> <p>The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; or</p> <p>The condition must have both: (i) been in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug class for the first time; or</p> <p>Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of homologous recombination deficiency (genomic instability) must be derived through a test that has been validated against the Myriad MyChoice HRD assay, which uses a score of 42 or greater as the threshold for HRD (genomic instability) positivity.</p><p align=""justify"">Evidence that BRCA1/2 gene mutations are absent must also be derived through a validated test as described above.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets</p><br/><p>The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND</p> <p>The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; or</p> <p>The condition must have both: (i) been in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug class for the first time; or</p> <p>Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of homologous recombination deficiency (genomic instability) must be derived through a test that has been validated against the Myriad MyChoice HRD assay, which uses a score of 42 or greater as the threshold for HRD (genomic instability) positivity.</p><p align=""justify"">Evidence that BRCA1/2 gene mutations are absent must also be derived through a validated test as described above.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15339_15339_R","null","AUTHORITY_REQUIRED","15339","15339","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Preservation of bone mineral density</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be on long-term glucocorticoid therapy; AND</p> <p>Patient must be undergoing continuous treatment with a dose equal to or greater than 7.5 mg of prednisone or equivalent per day; AND</p> <p>Patient must be osteopenic (bone mineral density t-score of less than -1.0).</p> <p>Prescribers need to demonstrate that the patient has been on continuous therapy for 3 months or more.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Preservation of bone mineral density</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be on long-term glucocorticoid therapy; AND</p> <p>Patient must be undergoing continuous treatment with a dose equal to or greater than 7.5 mg of prednisone or equivalent per day; AND</p> <p>Patient must be osteopenic (bone mineral density t-score of less than -1.0).</p> <p>Prescribers need to demonstrate that the patient has been on continuous therapy for 3 months or more.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15349_15376_R","Balance of supply","AUTHORITY_REQUIRED","15376","15349","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Balance of supply</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; or</p> <p>The treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Balance of supply</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; or</p> <p>The treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15359_15360_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","15360","15359","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriasis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>The condition must be ineffective to other systemic therapies; or</p> <p>The condition must be inappropriate for other systemic therapies; AND</p> <p>The condition must have caused significant interference with quality of life; AND</p> <p>Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; or</p> <p>Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar.</p> <p align=""justify"">For patients who do not demonstrate an adequate response to ciclosporin, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to &apos;biological medicines&apos; for the treatment of &apos;severe chronic plaque psoriasis&apos;.</p><p align=""justify"">This assessment must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Severe psoriasis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>The condition must be ineffective to other systemic therapies; or</p> <p>The condition must be inappropriate for other systemic therapies; AND</p> <p>The condition must have caused significant interference with quality of life; AND</p> <p>Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; or</p> <p>Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar.</p> <p align=""justify"">For patients who do not demonstrate an adequate response to ciclosporin, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to &apos;biological medicines&apos; for the treatment of &apos;severe chronic plaque psoriasis&apos;.</p><p align=""justify"">This assessment must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15365_15441_R","Initial first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets","AUTHORITY_REQUIRED","15441","15365","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets</p><br/><p>The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug class for the first time; or</p> <p>Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets</p><br/><p>The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug class for the first time; or</p> <p>Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15372_15372_R","null","RESTRICTED","15372","15372","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15373_15373_R","null","RESTRICTED","15373","15373","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven calcium malabsorption</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven calcium malabsorption</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15374_15374_R","null","AUTHORITY_REQUIRED","15374","15374","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have lower urinary tract symptoms.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have lower urinary tract symptoms.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15379_15347_R","Continuing treatment","AUTHORITY_REQUIRED","15347","15379","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An adequate response to omalizumab treatment is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).</p> <p align=""justify"">All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated.</p><p align=""justify"">The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient&apos;s response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.</p><p align=""justify"">A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of this biological medicine consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for up to 24 weeks of therapy.</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(b) If applicable, maintenance oral corticosteroid dose; and</p><p align=""justify"">(c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An adequate response to omalizumab treatment is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).</p> <p align=""justify"">All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated.</p><p align=""justify"">The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient&apos;s response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.</p><p align=""justify"">A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of this biological medicine consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for up to 24 weeks of therapy.</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(b) If applicable, maintenance oral corticosteroid dose; and</p><p align=""justify"">(c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15387_15387_R","Continuing or recommencement of treatment (within 12 months of a treatment break)","AUTHORITY_REQUIRED","15387","15387","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic lupus erythematosus</p><br/><p>Continuing or recommencement of treatment (within 12 months of a treatment break)</p><br/><p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>Patient must be responding to treatment if they have received less than 12 months of treatment with this drug for this condition; or</p> <p>Patient must have attained a Lupus Low Disease Activity State (LLDAS) and maintained this state while on treatment; AND</p> <p>Must be treated by a specialist physician experienced in the management of this condition.</p> <p align=""justify"">Lupus Low Disease Activity State (LLDAS) is defined as:</p><p align=""justify"">(a) Total SLEDAI-2K of not greater than 4, with no major activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever); and</p><p align=""justify"">(b) No new features of lupus disease activity compared with the previous assessment, and</p><p align=""justify"">(c) Physician Global Assessment (PGA) of not greater than 1, and</p><p align=""justify"">(d) Current prednisolone (or equivalent) dose of not greater than 7.5 mg daily, and</p><p align=""justify"">(e) Well tolerated standard maintenance doses of anti-malarial and immunosuppressive drugs are allowed.</p> <p align=""justify"">Where retreatment with anifrolumab after a break in PBS-subsidised treatment with anifrolumab is being sought, the date of cessation of the previous treatment course with anifrolumab must be included in the application. Recommencement of treatment with anifrolumab for severe SLE is within 12 months from the date that treatment was ceased.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic lupus erythematosus</p><br/><p>Continuing or recommencement of treatment (within 12 months of a treatment break)</p><br/><p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>Patient must be responding to treatment if they have received less than 12 months of treatment with this drug for this condition; or</p> <p>Patient must have attained a Lupus Low Disease Activity State (LLDAS) and maintained this state while on treatment; AND</p> <p>Must be treated by a specialist physician experienced in the management of this condition.</p> <p align=""justify"">Lupus Low Disease Activity State (LLDAS) is defined as:</p><p align=""justify"">(a) Total SLEDAI-2K of not greater than 4, with no major activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever); and</p><p align=""justify"">(b) No new features of lupus disease activity compared with the previous assessment, and</p><p align=""justify"">(c) Physician Global Assessment (PGA) of not greater than 1, and</p><p align=""justify"">(d) Current prednisolone (or equivalent) dose of not greater than 7.5 mg daily, and</p><p align=""justify"">(e) Well tolerated standard maintenance doses of anti-malarial and immunosuppressive drugs are allowed.</p> <p align=""justify"">Where retreatment with anifrolumab after a break in PBS-subsidised treatment with anifrolumab is being sought, the date of cessation of the previous treatment course with anifrolumab must be included in the application. Recommencement of treatment with anifrolumab for severe SLE is within 12 months from the date that treatment was ceased.</p> <p align=""justify"">SLEDAI-2K can be accessed via Gladman 2002 J. Rheumatol. 29 (2) 288-291 or from AstraZeneca Medical Information on 1800 805 342.</p> <p align=""justify"">PGA can be accessed via Petri 2005 N Engl J Med 353: 2550-8.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15392_15414_R","Initial first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets","AUTHORITY_REQUIRED","15414","15392","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets</p><br/><p>The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug class for the first time; or</p> <p>Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets</p><br/><p>The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug class for the first time; or</p> <p>Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15397_15397_R","null","RESTRICTED","15397","15397","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be associated with chronic renal failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be associated with chronic renal failure.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15398_15340_R","Balance of supply or change of therapy","AUTHORITY_REQUIRED","15340","15398","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Balance of supply or change of therapy</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; or</p> <p>Patient must be changing therapy from romiplostim or eltrombopag to this drug for this condition; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.</p> <p align=""justify"">Patients receiving treatment with romiplostim or eltrombopag may change to avatrombopag under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Balance of supply or change of therapy</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; or</p> <p>Patient must be changing therapy from romiplostim or eltrombopag to this drug for this condition; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.</p> <p align=""justify"">Patients receiving treatment with romiplostim or eltrombopag may change to avatrombopag under this restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15399_15375_R","First Continuing treatment or Re-initiation of interrupted continuing treatment","AUTHORITY_REQUIRED","15375","15399","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>First Continuing treatment or Re-initiation of interrupted continuing treatment</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have changed treatment from either romiplostim or eltrombopag to this drug under the Balance of Supply/Change of Therapy restriction and demonstrated a sustained response; or</p> <p>Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.</p> <p align=""justify"">The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>First Continuing treatment or Re-initiation of interrupted continuing treatment</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have changed treatment from either romiplostim or eltrombopag to this drug under the Balance of Supply/Change of Therapy restriction and demonstrated a sustained response; or</p> <p>Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.</p> <p align=""justify"">The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15405_15361_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","15361","15405","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriasis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>The condition must be ineffective to other systemic therapies; or</p> <p>The condition must be inappropriate for other systemic therapies; AND</p> <p>The condition must have caused significant interference with quality of life; AND</p> <p>Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; or</p> <p>Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar.</p> <p align=""justify"">For patients who do not demonstrate an adequate response to ciclosporin, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to &apos;biological medicines&apos; for the treatment of &apos;severe chronic plaque psoriasis&apos;.</p><p align=""justify"">This assessment must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Severe psoriasis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>The condition must be ineffective to other systemic therapies; or</p> <p>The condition must be inappropriate for other systemic therapies; AND</p> <p>The condition must have caused significant interference with quality of life; AND</p> <p>Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; or</p> <p>Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar.</p> <p align=""justify"">For patients who do not demonstrate an adequate response to ciclosporin, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to &apos;biological medicines&apos; for the treatment of &apos;severe chronic plaque psoriasis&apos;.</p><p align=""justify"">This assessment must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15415_15408_R","Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets","AUTHORITY_REQUIRED","15408","15415","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets</p><br/><p>The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND</p> <p>The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; or</p> <p>The condition must have both: (i) been in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug class for the first time; or</p> <p>Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of homologous recombination deficiency (genomic instability) must be derived through a test that has been validated against the Myriad MyChoice HRD assay, which uses a score of 42 or greater as the threshold for HRD (genomic instability) positivity.</p><p align=""justify"">Evidence that BRCA1/2 gene mutations are absent must also be derived through a validated test as described above.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets</p><br/><p>The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND</p> <p>The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND</p> <p>Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; or</p> <p>The condition must have both: (i) been in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug class for the first time; or</p> <p>Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p> <p align=""justify"">Evidence of homologous recombination deficiency (genomic instability) must be derived through a test that has been validated against the Myriad MyChoice HRD assay, which uses a score of 42 or greater as the threshold for HRD (genomic instability) positivity.</p><p align=""justify"">Evidence that BRCA1/2 gene mutations are absent must also be derived through a validated test as described above.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15419_15419_R","null","RESTRICTED","15419","15419","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypocalcaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypocalcaemia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15420_15420_R","null","RESTRICTED","15420","15420","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-07-01","N","4708"
"15449_15446_R","Continuing treatment","AUTHORITY_REQUIRED","15446","15449","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vision threatening non-infectious uveitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must demonstrated or sustained an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed 24 weeks under this restriction per authority application; AND</p> <p>Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or</p><p align=""justify"">(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or</p><p align=""justify"">(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or</p><p align=""justify"">(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet&apos;s disease only)</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vision threatening non-infectious uveitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must demonstrated or sustained an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed 24 weeks under this restriction per authority application; AND</p> <p>Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or</p><p align=""justify"">(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or</p><p align=""justify"">(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or</p><p align=""justify"">(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet&apos;s disease only)</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15451_15490_R","Initial treatment","AUTHORITY_REQUIRED","15490","15451","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neurofibromatosis type 1</p><br/><p>Initial treatment</p><br/><p>Patient must have plexiform neurofibroma(s) (PN) that is causing/likely to cause at least one of: (i) significant symptoms/morbidity, (ii) disability, (iii) disfigurement, (iv) impairment of normal body function; AND</p> <p>Patient must have PN for which complete resection cannot be performed; AND</p> <p>Patient must have either a: (i) Karnofsky, (ii) Lansky Performance Score of at least 70%; AND</p> <p>Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be aged between 2 to 18 years; AND</p> <p>Patient must be able to swallow the whole capsule form of this drug.</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised<b>.</b></p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, significant symptoms/morbidity are defined as, but not limited to:</p><p align=""justify"">1. head and neck PN that can compromise the airway or great vessels;</p><p align=""justify"">2. paraspinal PN that can cause myelopathy;</p><p align=""justify"">3. brachial or lumbar plexus PN that can cause nerve compression and loss of function;</p><p align=""justify"">4. PN that can result in major deformity or significant disfiguring (e.g. orbital PN);</p><p align=""justify"">5. PN of the extremity that can cause limb hypertrophy or loss of function; and</p><p align=""justify"">6. painful PN.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neurofibromatosis type 1</p><br/><p>Initial treatment</p><br/><p>Patient must have plexiform neurofibroma(s) (PN) that is causing/likely to cause at least one of: (i) significant symptoms/morbidity, (ii) disability, (iii) disfigurement, (iv) impairment of normal body function; AND</p> <p>Patient must have PN for which complete resection cannot be performed; AND</p> <p>Patient must have either a: (i) Karnofsky, (ii) Lansky Performance Score of at least 70%; AND</p> <p>Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be aged between 2 to 18 years; AND</p> <p>Patient must be able to swallow the whole capsule form of this drug.</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised<b>.</b></p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, significant symptoms/morbidity are defined as, but not limited to:</p><p align=""justify"">1. head and neck PN that can compromise the airway or great vessels;</p><p align=""justify"">2. paraspinal PN that can cause myelopathy;</p><p align=""justify"">3. brachial or lumbar plexus PN that can cause nerve compression and loss of function;</p><p align=""justify"">4. PN that can result in major deformity or significant disfiguring (e.g. orbital PN);</p><p align=""justify"">5. PN of the extremity that can cause limb hypertrophy or loss of function; and</p><p align=""justify"">6. painful PN.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-08-01","Y","4708"
"15452_15491_R","Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements","AUTHORITY_REQUIRED","15491","15452","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neurofibromatosis type 1</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must have previously received treatment with this drug for this condition prior to 1 August 2024; or</p> <p>Patient must have previously received treatment with another mitogen-activated protein kinase (MEK) inhibitor for this condition prior to 1 August 2024; AND</p> <p>Patient must have met all other PBS eligibility criteria that a non-''Grandfather'' patient would ordinarily be required to meet, meaning that at the time non-PBS-subsidised supply of a MEK inhibitor (including selumetinib) was commenced, the patient: (i) had PN that caused/was likely to cause at least one of: (a) significant symptoms/morbidity, (b) disability, (c) disfigurement, (d) impairment of normal body function; (ii) had PN for which complete PN resection could not be performed either: (a) safely, (b) without causing unacceptable morbidity; (iii) had either a: (a) Karnofsky, (b) Lansky Performance Score of at least 70%; (iv) was aged between 2 to 18 years; (v) was able to swallow the whole capsule form if received non-PBS supply with selumetinib; AND</p> <p>Patient must be tolerating treatment; AND</p> <p>Patient must have achieved either: (i) stabilisation of disease, (ii) adequate response to treatment, if have received at least 12 months of treatment; AND</p> <p>Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation.</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised<b>.</b></p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, significant symptoms/morbidity are defined as, but not limited to:</p><p align=""justify"">1. head and neck PN that can compromise the airway or great vessels;</p><p align=""justify"">2. paraspinal PN that can cause myelopathy;</p><p align=""justify"">3. brachial or lumbar plexus PN that can cause nerve compression and loss of function;</p><p align=""justify"">4. PN that can result in major deformity or significant disfiguring (e.g. orbital PN);</p><p align=""justify"">5. PN of the extremity that can cause limb hypertrophy or loss of function; and</p><p align=""justify"">6. painful PN.</p> <p align=""justify"">For the purpose of administering this restriction, adequate response is defined as:</p><p align=""justify"">1. stability or improvement of the initial baseline measurements prior to initiating treatment with this drug;</p><p align=""justify"">2. relevant imaging has not shown an increase in tumour size of 20% or more.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neurofibromatosis type 1</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must have previously received treatment with this drug for this condition prior to 1 August 2024; or</p> <p>Patient must have previously received treatment with another mitogen-activated protein kinase (MEK) inhibitor for this condition prior to 1 August 2024; AND</p> <p>Patient must have met all other PBS eligibility criteria that a non-''Grandfather'' patient would ordinarily be required to meet, meaning that at the time non-PBS-subsidised supply of a MEK inhibitor (including selumetinib) was commenced, the patient: (i) had PN that caused/was likely to cause at least one of: (a) significant symptoms/morbidity, (b) disability, (c) disfigurement, (d) impairment of normal body function; (ii) had PN for which complete PN resection could not be performed either: (a) safely, (b) without causing unacceptable morbidity; (iii) had either a: (a) Karnofsky, (b) Lansky Performance Score of at least 70%; (iv) was aged between 2 to 18 years; (v) was able to swallow the whole capsule form if received non-PBS supply with selumetinib; AND</p> <p>Patient must be tolerating treatment; AND</p> <p>Patient must have achieved either: (i) stabilisation of disease, (ii) adequate response to treatment, if have received at least 12 months of treatment; AND</p> <p>Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation.</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised<b>.</b></p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, significant symptoms/morbidity are defined as, but not limited to:</p><p align=""justify"">1. head and neck PN that can compromise the airway or great vessels;</p><p align=""justify"">2. paraspinal PN that can cause myelopathy;</p><p align=""justify"">3. brachial or lumbar plexus PN that can cause nerve compression and loss of function;</p><p align=""justify"">4. PN that can result in major deformity or significant disfiguring (e.g. orbital PN);</p><p align=""justify"">5. PN of the extremity that can cause limb hypertrophy or loss of function; and</p><p align=""justify"">6. painful PN.</p> <p align=""justify"">For the purpose of administering this restriction, adequate response is defined as:</p><p align=""justify"">1. stability or improvement of the initial baseline measurements prior to initiating treatment with this drug;</p><p align=""justify"">2. relevant imaging has not shown an increase in tumour size of 20% or more.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-08-01","Y","4708"
"15465_15526_R","Initial treatment","AUTHORITY_REQUIRED","15526","15465","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory Acute Myeloid Leukaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The condition must not be acute promyelocytic leukaemia; AND</p> <p>The condition must be internal tandem duplication (ITD) and/or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 prior to treatment initiation; AND</p> <p>The treatment must not be for maintenance therapy post-transplant.</p> <p align=""justify"">The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient&apos;s file.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory Acute Myeloid Leukaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The condition must not be acute promyelocytic leukaemia; AND</p> <p>The condition must be internal tandem duplication (ITD) and/or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 prior to treatment initiation; AND</p> <p>The treatment must not be for maintenance therapy post-transplant.</p> <p align=""justify"">The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient&apos;s file.</p>","N","N","N","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15467_C","null","null","null","null","null","<p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p>","N","Y","N","null","null","N","2015-07-01","N","4708"
"15471_15471_R","null","STREAMLINED","15471","15471","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resectable non-small cell lung cancer (NSCLC)</p><br/><p>The condition must be at least one of: (i) node positive, (ii) at least 4 cm in size; AND</p> <p>The treatment must be for neoadjuvant use in a patient preparing for surgical resection; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be in combination with platinum-based chemotherapy; AND</p> <p>Patient must not be undergoing treatment with more than 3 PBS-subsidised doses of this drug per lifetime for this indication.</p> <p align=""justify"">In non-squamous type NSCLC where any of the following is known to be present, this drug must not be a PBS benefit: (i) activating epidermal growth factor receptor (EGFR) gene mutation, (ii) anaplastic lymphoma kinase (ALK) gene rearrangement.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resectable non-small cell lung cancer (NSCLC)</p><br/><p>The condition must be at least one of: (i) node positive, (ii) at least 4 cm in size; AND</p> <p>The treatment must be for neoadjuvant use in a patient preparing for surgical resection; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be in combination with platinum-based chemotherapy; AND</p> <p>Patient must not be undergoing treatment with more than 3 PBS-subsidised doses of this drug per lifetime for this indication.</p> <p align=""justify"">In non-squamous type NSCLC where any of the following is known to be present, this drug must not be a PBS benefit: (i) activating epidermal growth factor receptor (EGFR) gene mutation, (ii) anaplastic lymphoma kinase (ALK) gene rearrangement.</p>","N","N","N","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15472_15489_R","Recommencement of treatment","AUTHORITY_REQUIRED","15489","15472","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vision threatening non-infectious uveitis</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have a documented history of non-infectious uveitis that is vision threatening; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment prior to having a break in therapy with this drug for this condition; AND</p> <p>The treatment must not exceed 25 weeks under this restriction; AND</p> <p>Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or</p><p align=""justify"">(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or</p><p align=""justify"">(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or</p><p align=""justify"">(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet&apos;s disease only)</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vision threatening non-infectious uveitis</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have a documented history of non-infectious uveitis that is vision threatening; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment prior to having a break in therapy with this drug for this condition; AND</p> <p>The treatment must not exceed 25 weeks under this restriction; AND</p> <p>Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or</p><p align=""justify"">(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or</p><p align=""justify"">(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or</p><p align=""justify"">(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet&apos;s disease only)</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15473_15473_R","Balance of Supply","AUTHORITY_REQUIRED","15473","15473","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vision threatening non-infectious uveitis</p><br/><p>Balance of Supply</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition to complete one of the following: (i) 25 weeks for initial treatment; (ii) 25 weeks for recommencement treatment; (iii) 24 weeks for continuing treatment; (iv) 24 weeks for transitioning from non-PBS to PBS-subsidised treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vision threatening non-infectious uveitis</p><br/><p>Balance of Supply</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition to complete one of the following: (i) 25 weeks for initial treatment; (ii) 25 weeks for recommencement treatment; (iii) 24 weeks for continuing treatment; (iv) 24 weeks for transitioning from non-PBS to PBS-subsidised treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15477_15477_R","Continuing treatment","AUTHORITY_REQUIRED","15477","15477","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neurofibromatosis type 1</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be tolerating treatment; AND</p> <p>Patient must have achieved either: (i) stabilisation of disease, (ii) adequate response to treatment, if have received at least 12 months of treatment with this drug; AND</p> <p>Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation.</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised<b>.</b></p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, adequate response is defined as:</p><p align=""justify"">1. stability or improvement of the initial baseline measurements prior to initiating treatment with this drug;</p><p align=""justify"">2. relevant imaging has not shown an increase in tumour size of 20% or more.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neurofibromatosis type 1</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be tolerating treatment; AND</p> <p>Patient must have achieved either: (i) stabilisation of disease, (ii) adequate response to treatment, if have received at least 12 months of treatment with this drug; AND</p> <p>Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation.</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised<b>.</b></p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, adequate response is defined as:</p><p align=""justify"">1. stability or improvement of the initial baseline measurements prior to initiating treatment with this drug;</p><p align=""justify"">2. relevant imaging has not shown an increase in tumour size of 20% or more.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15480_15454_R","Initial treatment","STREAMLINED","15454","15480","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic differentiated thyroid cancer</p><br/><p>Initial treatment</p><br/><p>The condition must be refractory to radioactive iodine; or</p> <p>Patient must be deemed ineligible for treatment with radioactive iodine; AND</p> <p>Patient must have progressive disease according to Response Evaluation Criteria in Solid Tumours (RECIST) whilst on treatment with a vascular endothelial growth factor (VEGF)-targeted tyrosine kinase inhibitor (TKI) for this indication; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to prior VEGF-targeted TKI therapy; AND</p> <p>Patient must have a WHO performance status of no higher than 2; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have thyroid stimulating hormone adequately suppressed.</p> <p align=""justify"">Radioactive iodine refractory is defined as:</p><p align=""justify"">(i) a lesion without iodine uptake on a radioactive iodine (RAI) scan; or</p><p align=""justify"">(ii) having received a cumulative RAI dose of greater than or equal to 600 mCi; or</p><p align=""justify"">(iii) progression within 12 months of a single RAI treatment; or</p><p align=""justify"">(iv) progression after two RAI treatments administered within 12 months of each other.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic differentiated thyroid cancer</p><br/><p>Initial treatment</p><br/><p>The condition must be refractory to radioactive iodine; or</p> <p>Patient must be deemed ineligible for treatment with radioactive iodine; AND</p> <p>Patient must have progressive disease according to Response Evaluation Criteria in Solid Tumours (RECIST) whilst on treatment with a vascular endothelial growth factor (VEGF)-targeted tyrosine kinase inhibitor (TKI) for this indication; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to prior VEGF-targeted TKI therapy; AND</p> <p>Patient must have a WHO performance status of no higher than 2; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have thyroid stimulating hormone adequately suppressed.</p> <p align=""justify"">Radioactive iodine refractory is defined as:</p><p align=""justify"">(i) a lesion without iodine uptake on a radioactive iodine (RAI) scan; or</p><p align=""justify"">(ii) having received a cumulative RAI dose of greater than or equal to 600 mCi; or</p><p align=""justify"">(iii) progression within 12 months of a single RAI treatment; or</p><p align=""justify"">(iv) progression after two RAI treatments administered within 12 months of each other.</p>","N","N","N","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15483_15456_R","Continuing treatment","AUTHORITY_REQUIRED","15456","15483","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Generalized convulsive status epilepticus</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of the authority application, practitioners should request the appropriate quantity to cater for the patient&apos;s circumstances.</p><p align=""justify"">Up to a maximum of 10 syringes for each prescription can be authorised for patients with high frequency seizures.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Generalized convulsive status epilepticus</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of the authority application, practitioners should request the appropriate quantity to cater for the patient&apos;s circumstances.</p><p align=""justify"">Up to a maximum of 10 syringes for each prescription can be authorised for patients with high frequency seizures.</p>","N","N","N","IMMEDIATE","ALL","Y","2024-08-01","N","4708"
"15487_15525_R","Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag","AUTHORITY_REQUIRED","15525","15487","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag</p><br/><p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">The authority application for selexipag must be approved prior to the authority application for this agent.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align=""justify"">PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) is defined as follows:</p><p align=""justify"">(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or</p><p align=""justify"">(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.</p> <p align=""justify"">The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient&apos;s medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient&apos;s medical record.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag</p><br/><p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">The authority application for selexipag must be approved prior to the authority application for this agent.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align=""justify"">PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) is defined as follows:</p><p align=""justify"">(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or</p><p align=""justify"">(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.</p> <p align=""justify"">The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient&apos;s medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient&apos;s medical record.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p> <p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p>","N","N","Y","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15488_15474_R","Initial treatment","AUTHORITY_REQUIRED","15474","15488","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vision threatening non-infectious uveitis</p><br/><p>Initial treatment</p><br/><p>Patient must have non-infectious uveitis that is vision threatening with the diagnosis confirmed by an ophthalmologist, rheumatologist, or immunologist; AND</p> <p>Patient must have failed to achieve an adequate response to corticosteroid therapy in combination with at least 1 immunosuppressive agent; or</p> <p>Patient must have flared when corticosteroid therapy was tapered to a dose of less than or equal to 7.5 mg per day of prednisone or equivalent while on immunomodulatory therapy; or</p> <p>Patient must have failed to achieve an adequate response to at least one immunosuppressive agent in patients for whom corticosteroids are not clinically appropriate; or</p> <p>Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to corticosteroid and immunomodulatory therapy; AND</p> <p>The treatment must not exceed 25 weeks under this restriction; AND</p> <p>Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Vision threatening disease is defined as at least 1 of the following:</p><p align=""justify"">(a) A decrease in visual acuity of at least 10 letters using an ETDRS chart or equivalent;</p><p align=""justify"">(b) A 2-step increase in anterior chamber cells or vitreous haze;</p><p align=""justify"">(c) New retinal vasculitis;</p><p align=""justify"">(d) New retinal or choroidal lesions;</p><p align=""justify"">(e) Other signs of disease progression including visual field changes or electroretinogram changes</p> <p align=""justify"">A failure to achieve an adequate response is defined as failure to meet one or more of the below criteria:</p><p align=""justify"">(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or</p><p align=""justify"">(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or</p><p align=""justify"">(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or</p><p align=""justify"">(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet&apos;s disease only)</p> <p align=""justify"">Details of prior immunomodulatory agent and corticosteroid treatment, or details of contraindications or developed intolerances necessitating treatment withdrawal, must be documented in the patient&apos;s medical record.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include details of vision threatening disease.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vision threatening non-infectious uveitis</p><br/><p>Initial treatment</p><br/><p>Patient must have non-infectious uveitis that is vision threatening with the diagnosis confirmed by an ophthalmologist, rheumatologist, or immunologist; AND</p> <p>Patient must have failed to achieve an adequate response to corticosteroid therapy in combination with at least 1 immunosuppressive agent; or</p> <p>Patient must have flared when corticosteroid therapy was tapered to a dose of less than or equal to 7.5 mg per day of prednisone or equivalent while on immunomodulatory therapy; or</p> <p>Patient must have failed to achieve an adequate response to at least one immunosuppressive agent in patients for whom corticosteroids are not clinically appropriate; or</p> <p>Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to corticosteroid and immunomodulatory therapy; AND</p> <p>The treatment must not exceed 25 weeks under this restriction; AND</p> <p>Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Vision threatening disease is defined as at least 1 of the following:</p><p align=""justify"">(a) A decrease in visual acuity of at least 10 letters using an ETDRS chart or equivalent;</p><p align=""justify"">(b) A 2-step increase in anterior chamber cells or vitreous haze;</p><p align=""justify"">(c) New retinal vasculitis;</p><p align=""justify"">(d) New retinal or choroidal lesions;</p><p align=""justify"">(e) Other signs of disease progression including visual field changes or electroretinogram changes</p> <p align=""justify"">A failure to achieve an adequate response is defined as failure to meet one or more of the below criteria:</p><p align=""justify"">(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or</p><p align=""justify"">(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or</p><p align=""justify"">(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or</p><p align=""justify"">(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet&apos;s disease only)</p> <p align=""justify"">Details of prior immunomodulatory agent and corticosteroid treatment, or details of contraindications or developed intolerances necessitating treatment withdrawal, must be documented in the patient&apos;s medical record.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include details of vision threatening disease.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-08-01","Y","4708"
"15492_15455_R","1,875 mg administered once every 3 weeks","STREAMLINED","15455","15492","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC)</p><br/><p>1,875 mg administered once every 3 weeks</p><br/><p>Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or</p> <p>Patient must be continuing existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND</p> <p>The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND</p> <p>The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words ''cancelled'' where (i)/(ii) has occurred.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC)</p><br/><p>1,875 mg administered once every 3 weeks</p><br/><p>Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or</p> <p>Patient must be continuing existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND</p> <p>The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND</p> <p>The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words ''cancelled'' where (i)/(ii) has occurred.</p>","N","N","N","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15496_15509_R","Continuing treatment","AUTHORITY_REQUIRED","15509","15496","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be either: (i) non-small cell lung cancer, (ii) soft tissue sarcoma, (iii) glioma, (iv), glioneuronal tumour, (v) glioblastoma; AND</p> <p>The treatment must cease to be a PBS benefit upon radiographic progression; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where radiographic progression is observed, mark any remaining repeat prescriptions with the word &apos;cancelled&apos;.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be either: (i) non-small cell lung cancer, (ii) soft tissue sarcoma, (iii) glioma, (iv), glioneuronal tumour, (v) glioblastoma; AND</p> <p>The treatment must cease to be a PBS benefit upon radiographic progression; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where radiographic progression is observed, mark any remaining repeat prescriptions with the word &apos;cancelled&apos;.</p>","N","N","N","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15497_15467_R","Initial treatment","AUTHORITY_REQUIRED","15467","15497","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion</p><br/><p>Initial treatment</p><br/><p>The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND</p> <p>The condition must be non-small cell lung cancer confirmed through a pathology report from an Approved Pathology Authority (of any date); or</p> <p>The condition must be soft tissue sarcoma confirmed through a pathology report from an Approved Pathology Authority (of any date); or</p> <p>The condition must be confirmed through a pathology report from an Approved Pathology Authority (of any date) as either: (i) glioma, (ii) glioneuronal tumour, (iii) glioblastoma; AND</p> <p>The condition must be metastatic disease; or</p> <p>The condition must be both: (i) locally advanced, (ii) unresectable; or</p> <p>The condition must be locally advanced where surgical resection is likely to result in severe morbidity; AND</p> <p>Patient must have received prior systemic treatment for this disease; or</p> <p>Patient must have a condition that predisposes them to an unacceptable risk of intolerance to other systemic therapies; AND</p> <p>The treatment must be the sole PBS-subsidised anti-cancer therapy for this condition; AND</p> <p>Patient must not receive more than 3 months of treatment under this restriction; AND</p> <p>Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:</p><p align=""justify"">(a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date.</p><p align=""justify"">(b) details of the pathology report establishing the carcinoma type (non-small cell lung cancer, soft tissue sarcoma or either glioma/ glioneuronal tumour/ glioblastoma) being treated, if different to the pathology report provided to substantiate the NTRK gene fusion.</p><p align=""justify"">(c) details of prior systemic treatment for this disease or details of the condition that predisposes the patient to an unacceptable risk of intolerance to other systemic therapies.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion</p><br/><p>Initial treatment</p><br/><p>The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND</p> <p>The condition must be non-small cell lung cancer confirmed through a pathology report from an Approved Pathology Authority (of any date); or</p> <p>The condition must be soft tissue sarcoma confirmed through a pathology report from an Approved Pathology Authority (of any date); or</p> <p>The condition must be confirmed through a pathology report from an Approved Pathology Authority (of any date) as either: (i) glioma, (ii) glioneuronal tumour, (iii) glioblastoma; AND</p> <p>The condition must be metastatic disease; or</p> <p>The condition must be both: (i) locally advanced, (ii) unresectable; or</p> <p>The condition must be locally advanced where surgical resection is likely to result in severe morbidity; AND</p> <p>Patient must have received prior systemic treatment for this disease; or</p> <p>Patient must have a condition that predisposes them to an unacceptable risk of intolerance to other systemic therapies; AND</p> <p>The treatment must be the sole PBS-subsidised anti-cancer therapy for this condition; AND</p> <p>Patient must not receive more than 3 months of treatment under this restriction; AND</p> <p>Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:</p><p align=""justify"">(a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date.</p><p align=""justify"">(b) details of the pathology report establishing the carcinoma type (non-small cell lung cancer, soft tissue sarcoma or either glioma/ glioneuronal tumour/ glioblastoma) being treated, if different to the pathology report provided to substantiate the NTRK gene fusion.</p><p align=""justify"">(c) details of prior systemic treatment for this disease or details of the condition that predisposes the patient to an unacceptable risk of intolerance to other systemic therapies.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2024-08-01","Y","4708"
"15499_15445_R","Continuing treatment","STREAMLINED","15445","15499","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vision threatening non-infectious uveitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed 24 weeks under this restriction per authority application; AND</p> <p>Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or</p><p align=""justify"">(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or</p><p align=""justify"">(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or</p><p align=""justify"">(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet&apos;s disease only)</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vision threatening non-infectious uveitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed 24 weeks under this restriction per authority application; AND</p> <p>Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or</p><p align=""justify"">(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or</p><p align=""justify"">(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or</p><p align=""justify"">(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet&apos;s disease only)</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15504_15485_R","Maintenance therapy - Initial treatment","STREAMLINED","15485","15504","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer</p><br/><p>Maintenance therapy - Initial treatment</p><br/><p>Patient must have received first-line platinum-based chemotherapy; AND</p> <p>Patient must not have progressive disease following first-line platinum-based chemotherapy; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer</p><br/><p>Maintenance therapy - Initial treatment</p><br/><p>Patient must have received first-line platinum-based chemotherapy; AND</p> <p>Patient must not have progressive disease following first-line platinum-based chemotherapy; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15506_15463_R","Initial 3 - changing to this drug in combination therapy (dual or triple therapy)","AUTHORITY_REQUIRED","15463","15506","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 3 - changing to this drug in combination therapy (dual or triple therapy)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 3 - changing to this drug in combination therapy (dual or triple therapy)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15516_15500_R","Initial treatment","STREAMLINED","15500","15516","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III non-small cell lung cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have received platinum based chemoradiation therapy; AND</p> <p>The condition must not have progressed following platinum based chemoradiation therapy; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must be untreated with immunotherapy at commencement of this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III non-small cell lung cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have received platinum based chemoradiation therapy; AND</p> <p>The condition must not have progressed following platinum based chemoradiation therapy; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must be untreated with immunotherapy at commencement of this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15520_15495_R","Continuing treatment","AUTHORITY_REQUIRED","15495","15520","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15528_15469_R","null","STREAMLINED","15469","15528","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy; AND</p> <p>Patient must be at least 18 years of age.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy; AND</p> <p>Patient must be at least 18 years of age.</p>","N","N","N","IMMEDIATE","ALL","N","2024-08-01","N","4708"
"15533_15585_R","null","RESTRICTED","15585","15533","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be paraplegic or quadriplegic or have severe neurogenic impairment of bowel function.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be paraplegic or quadriplegic or have severe neurogenic impairment of bowel function.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15534_15734_R","null","RESTRICTED","15734","15534","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15537_15659_R","null","RESTRICTED","15659","15537","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic bronchitis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 8 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic bronchitis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 8 years or older.</p> <p align=""justify"">Pharmaceutical benefits that have the forms doxycycline tablet 50 mg (as hyclate (hydrochloride)), doxycycline tablet 50 mg (as monohydrate) and doxycycline modified release capsule 50 mg (as hyclate (hydrochloride)) are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15538_15539_R","null","RESTRICTED","15539","15538","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15540_15658_R","null","STREAMLINED","15658","15540","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Scleroderma oesophagus</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Scleroderma oesophagus</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15541_15542_R","Maintenance therapy","STREAMLINED","15542","15541","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>Patient must have been commenced on treatment in a specialist unit in a hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>Patient must have been commenced on treatment in a specialist unit in a hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15544_15600_R","null","RESTRICTED","15600","15544","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be unable to achieve co-ordinated use of other metered dose inhalers containing this drug.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be unable to achieve co-ordinated use of other metered dose inhalers containing this drug.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15545_15548_R","null","STREAMLINED","15548","15545","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND</p> <p>Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND</p> <p>Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months.</p> <p/><p align=""justify"">This product is not indicated for the initiation of bronchodilator therapy in COPD. </p><p/> <p align=""justify"">The treatment must not be used in combination with LABA monotherapy or LAMA/LABA combination therapy.</p> <p align=""justify"">A LAMA/LABA includes aclidinium/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, or umeclidinium/vilanterol.</p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15547_15543_R","null","STREAMLINED","15543","15547","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months, with significant symptoms despite regular bronchodilator therapy with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonist (LABA) or an inhaled corticosteroid (ICS) and a LABA; or</p> <p>Patient must have been stabilised on a combination of a LAMA, LABA and an ICS for this condition; AND</p> <p>Patient must not be undergoing treatment with this product in each of the following circumstances: (i) treatment of asthma in the absence of a COPD diagnosis, (ii) initiation of bronchodilator therapy in COPD, (iii) use as reliever therapy for asthma, (iv) dosed at an interval/frequency that differs to that recommended in the approved Product Information.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months, with significant symptoms despite regular bronchodilator therapy with a long acting muscarinic antagonist (LAMA) and a long acting beta-2 agonist (LABA) or an inhaled corticosteroid (ICS) and a LABA; or</p> <p>Patient must have been stabilised on a combination of a LAMA, LABA and an ICS for this condition; AND</p> <p>Patient must not be undergoing treatment with this product in each of the following circumstances: (i) treatment of asthma in the absence of a COPD diagnosis, (ii) initiation of bronchodilator therapy in COPD, (iii) use as reliever therapy for asthma, (iv) dosed at an interval/frequency that differs to that recommended in the approved Product Information.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15549_15607_R","null","RESTRICTED","15607","15549","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must experience frequent episodes of the condition; AND</p> <p>Patient must be currently receiving treatment with oral corticosteroids; or</p> <p>Patient must be currently receiving treatment with optimal doses of inhaled corticosteroids.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must experience frequent episodes of the condition; AND</p> <p>Patient must be currently receiving treatment with oral corticosteroids; or</p> <p>Patient must be currently receiving treatment with optimal doses of inhaled corticosteroids.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15549_N","null","null","null","null","null","<p>Pharmaceutical benefits that have the form ondansetron tablet (orally disintegrating) 4 mg and pharmaceutical benefits that have the form ondansetron 4 mg wafer are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"15550_N","null","null","null","null","null","<p>Pharmaceutical benefits that have the form ondansetron tablet (orally disintegrating) 8 mg and pharmaceutical benefits that have the form ondansetron 8 mg wafer are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"15552_15606_R","null","RESTRICTED","15606","15552","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15555_15559_R","null","STREAMLINED","15559","15555","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe dry eye syndrome</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be sensitive to preservatives in multi-dose eye drops.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe dry eye syndrome</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be sensitive to preservatives in multi-dose eye drops.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15557_15558_R","null","RESTRICTED","15558","15557","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Elevated intra-ocular pressure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must have been inadequately controlled with monotherapy; AND</p> <p>Patient must have open-angle glaucoma; or</p> <p>Patient must have ocular hypertension.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Elevated intra-ocular pressure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must have been inadequately controlled with monotherapy; AND</p> <p>Patient must have open-angle glaucoma; or</p> <p>Patient must have ocular hypertension.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15561_15560_R","null","RESTRICTED","15560","15561","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe dry eye syndrome</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe dry eye syndrome</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15563_15643_R","First-line prevention","STREAMLINED","15643","15563","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>First-line prevention</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be frequent intermittent; or</p> <p>The condition must be mild persistent; AND</p> <p>The treatment must be the single preventer agent; AND</p> <p>The treatment must be an alternative to sodium cromoglycate; or</p> <p>The treatment must be an alternative to nedocromil sodium; AND</p> <p>Patient must be aged 6 to 14 years inclusive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>First-line prevention</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be frequent intermittent; or</p> <p>The condition must be mild persistent; AND</p> <p>The treatment must be the single preventer agent; AND</p> <p>The treatment must be an alternative to sodium cromoglycate; or</p> <p>The treatment must be an alternative to nedocromil sodium; AND</p> <p>Patient must be aged 6 to 14 years inclusive.</p> <p align=""justify"">This drug is not PBS-subsidised for use in a patient aged 15 years or older, or for use in addition to a long-acting beta-agonist in any age group, or for use as a single second line preventer, as an alternative to corticosteroids, in a child aged 6 to 14 years with moderate to severe asthma.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15571_15530_R","null","STREAMLINED","15530","15571","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastro-oesophageal reflux disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be for long-term maintenance of gastro-oesophageal reflux disease in a patient with symptoms inadequately controlled using a low dose proton pump inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastro-oesophageal reflux disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be for long-term maintenance of gastro-oesophageal reflux disease in a patient with symptoms inadequately controlled using a low dose proton pump inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15573_15678_R","null","STREAMLINED","15678","15573","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Zollinger-Ellison syndrome</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Zollinger-Ellison syndrome</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15576_15617_R","null","STREAMLINED","15617","15576","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.</p> <p align=""justify"">Patient must be aged 18 years or older.</p> <p align=""justify"">Budesonide/formoterol fumarate dihydrate powder for inhalation 400/12 microgram strength inhalers are not recommended nor PBS-subsidised for use as &apos;maintenance and reliever&apos; therapy.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15579_15653_R","null","STREAMLINED","15653","15579","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">This product is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15581_15666_R","null","RESTRICTED","15666","15581","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depressive disorders</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depressive disorders</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15588_15536_R","Continuing treatment","STREAMLINED","15536","15588","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months therapy; AND</p> <p>Must be treated by a specialist; or</p> <p>Must be treated by a consultant physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months therapy; AND</p> <p>Must be treated by a specialist; or</p> <p>Must be treated by a consultant physician.</p> <p>Up to a maximum of 18 pens will be reimbursed through the PBS. </p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15589_15657_R","null","RESTRICTED","15657","15589","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must not be responding to other tetracyclines.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">There are concerns about the incidence of benign intracranial hypertension associated with this drug.</p> <p>Severe acne</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must not be responding to other tetracyclines.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15590_15596_R","null","RESTRICTED","15596","15590","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchiectasis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 8 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchiectasis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 8 years or older.</p> <p align=""justify"">Pharmaceutical benefits that have the forms doxycycline tablet 50 mg (as hyclate (hydrochloride)), doxycycline tablet 50 mg (as monohydrate) and doxycycline modified release capsule 50 mg (as hyclate (hydrochloride)) are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15592_15709_R","null","RESTRICTED","15709","15592","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Faecal impaction</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Faecal impaction</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15595_15686_R","null","RESTRICTED","15686","15595","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p> <p align=""justify"">Pharmaceutical benefits that have the forms doxycycline tablet 50 mg (as hyclate (hydrochloride)), doxycycline tablet 50 mg (as monohydrate) and doxycycline modified release capsule 50 mg (as hyclate (hydrochloride)) are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15597_15574_R","null","RESTRICTED","15574","15597","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastro-oesophageal reflux disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastro-oesophageal reflux disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15598_15599_R","null","STREAMLINED","15599","15598","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy; AND</p> <p>Patient must be at least 18 years of age.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy; AND</p> <p>Patient must be at least 18 years of age.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15605_15751_R","null","RESTRICTED","15751","15605","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15613_15633_R","null","RESTRICTED","15633","15613","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Scleroderma oesophagus</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Scleroderma oesophagus</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15614_15575_R","null","RESTRICTED","15575","15614","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Zollinger-Ellison syndrome</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Zollinger-Ellison syndrome</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15616_15680_R","null","STREAMLINED","15680","15616","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15619_15722_R","null","RESTRICTED","15722","15619","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Panic disorder</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Panic disorder</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15620_15582_R","null","RESTRICTED","15582","15620","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Obsessive-compulsive disorder</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Obsessive-compulsive disorder</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15621_15583_R","null","RESTRICTED","15583","15621","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Panic disorder</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be for use when other treatments have failed; or</p> <p>The treatment must be for use when other treatments are inappropriate.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Panic disorder</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be for use when other treatments have failed; or</p> <p>The treatment must be for use when other treatments are inappropriate.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15626_15586_R","null","RESTRICTED","15586","15626","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15627_15629_R","null","RESTRICTED","15629","15627","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15628_15572_R","null","RESTRICTED","15572","15628","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Terminal malignant neoplasia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Terminal malignant neoplasia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15630_15727_R","null","RESTRICTED","15727","15630","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Megacolon</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Megacolon</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15632_15593_R","null","RESTRICTED","15593","15632","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15637_15634_R","null","RESTRICTED","15634","15637","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p> <p align=""justify"">The treatment must not be used in combination with a LAMA/LABA or SAMA</p> <p align=""justify"">A LAMA/LABA includes aclidinium/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, or umeclidinium/vilanterol.</p> <p align=""justify"">A SAMA includes ipratropium</p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15638_15698_R","null","RESTRICTED","15698","15638","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15641_15642_R","First-line prevention","STREAMLINED","15642","15641","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>First-line prevention</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 2 to 5 years inclusive; AND</p> <p>The condition must be frequent intermittent; or</p> <p>The condition must be mild persistent; AND</p> <p>The treatment must be the single preventer agent; AND</p> <p>The treatment must be an alternative to sodium cromoglycate; or</p> <p>The treatment must be an alternative to nedocromil sodium.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>First-line prevention</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be aged 2 to 5 years inclusive; AND</p> <p>The condition must be frequent intermittent; or</p> <p>The condition must be mild persistent; AND</p> <p>The treatment must be the single preventer agent; AND</p> <p>The treatment must be an alternative to sodium cromoglycate; or</p> <p>The treatment must be an alternative to nedocromil sodium.</p> <p>This drug is not PBS-subsidised for use in a child aged 2 to 5 years with moderate to severe asthma. It is not intended as an alternative for a child aged 2 to 5 years who requires a corticosteroid as a preventer medication.</p> <p align=""justify"">This drug is not subsidised in a child aged 2 to 5 years for use in combination with other preventer medications. PBS subsidy for this drug will therefore cease for a child aged 2 to 5 years who requires a preventer medication in addition to this drug.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15645_15691_R","null","STREAMLINED","15691","15645","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA); or</p> <p>Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting beta 2 agonist (LABA); or</p> <p>Patient must have been stabilised on a combination of a LAMA and a LABA.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA); or</p> <p>Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting beta 2 agonist (LABA); or</p> <p>Patient must have been stabilised on a combination of a LAMA and a LABA.</p> <p/><p align=""justify"">This product is not PBS-subsidised for the treatment of asthma.</p><p/> <p/><p align=""justify"">This product is not indicated for the initiation of bronchodilator therapy in COPD. </p><p/> <p align=""justify"">The treatment must not be used in combination with an ICS/LABA, LAMA, LABA, or SAMA</p> <p/><p align=""justify"">A LAMA includes tiotropium, glycopyrronium, aclidinium or umeclidinium.</p><p/> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">A SAMA includes ipratropium</p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15646_15699_R","null","RESTRICTED","15699","15646","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15647_15648_R","null","RESTRICTED","15648","15647","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15650_15707_R","null","RESTRICTED","15707","15650","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anorectal congenital abnormalities</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anorectal congenital abnormalities</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15651_15702_R","null","STREAMLINED","15702","15651","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15652_15577_R","null","STREAMLINED","15577","15652","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition; AND</p> <p>Must be treated by a respiratory physician; or</p> <p>Must be treated by a paediatrician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition; AND</p> <p>Must be treated by a respiratory physician; or</p> <p>Must be treated by a paediatrician.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15660_15729_R","null","RESTRICTED","15729","15660","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have malignant neoplasia.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have malignant neoplasia.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15663_15635_R","null","STREAMLINED","15635","15663","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">Flutiform is not recommended nor PBS-subsidised for use as &apos;maintenance and reliever&apos; therapy.</p> <p align=""justify"">Flutiform is not indicated or PBS-subsidised for bronchodilator therapy in COPD. </p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15664_15601_R","null","STREAMLINED","15601","15664","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15665_15715_R","null","STREAMLINED","15715","15665","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 4 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 4 years or older.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15667_15669_R","null","RESTRICTED","15669","15667","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15668_15550_R","null","RESTRICTED","15550","15668","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15671_15556_R","null","RESTRICTED","15556","15671","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe dry eye syndrome</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe dry eye syndrome</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15672_15644_R","Prevention of condition","STREAMLINED","15644","15672","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Prevention of condition</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be exercise-induced; AND</p> <p>The treatment must be as an alternative to adding salmeterol xinafoate; or</p> <p>The treatment must be an alternative to adding formoterol fumarate; AND</p> <p>The condition must be otherwise well controlled while receiving optimal dose inhaled corticosteroid; AND</p> <p>Patient must require short-acting beta-2 agonist 3 or more times per week for prevention or relief of residual exercise-related symptoms; AND</p> <p>Patient must be aged 6 to 14 years inclusive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Prevention of condition</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be exercise-induced; AND</p> <p>The treatment must be as an alternative to adding salmeterol xinafoate; or</p> <p>The treatment must be an alternative to adding formoterol fumarate; AND</p> <p>The condition must be otherwise well controlled while receiving optimal dose inhaled corticosteroid; AND</p> <p>Patient must require short-acting beta-2 agonist 3 or more times per week for prevention or relief of residual exercise-related symptoms; AND</p> <p>Patient must be aged 6 to 14 years inclusive.</p> <p align=""justify"">This drug is not PBS-subsidised for use in a patient aged 15 years or older, or for use in addition to a long-acting beta-agonist in any age group, or for use as a single second line preventer, as an alternative to corticosteroids, in a child aged 6 to 14 years with moderate to severe asthma.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15674_15566_R","null","RESTRICTED","15566","15674","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND</p> <p>The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND</p> <p>The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.</p> <p align=""justify"">Formal assessment and correction of inhaler technique should be performed in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique (available at www.humanservices.gov.au or www.nationalasthma.org.au); the assessment and adherence to correct technique should be documented in the patient&apos;s medical records. Patients can obtain support with inhaler technique through their local Asthma Foundation (1800 645 130).</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15676_15611_R","null","RESTRICTED","15611","15676","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p> <p align=""justify"">The treatment must not be used in combination with a LAMA/LABA or SAMA</p> <p align=""justify"">A LAMA/LABA includes aclidinium/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, or umeclidinium/vilanterol.</p> <p align=""justify"">A SAMA includes ipratropium</p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15679_15615_R","null","STREAMLINED","15615","15679","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">Unlike Symbicort Turbuhaler 200/6, Symbicort Rapihaler 200/6 is not recommended nor PBS-subsidised for use as &apos;maintenance and reliever&apos; therapy as the approved Product Information does not specify such use.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15681_15578_R","null","STREAMLINED","15578","15681","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must require long-term steroid therapy; AND</p> <p>Patient must not be able to use other forms of inhaled steroid therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must require long-term steroid therapy; AND</p> <p>Patient must not be able to use other forms of inhaled steroid therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15683_15708_R","null","RESTRICTED","15708","15683","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15684_15535_R","null","RESTRICTED","15535","15684","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Terminal malignant neoplasia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Terminal malignant neoplasia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15685_15587_R","null","RESTRICTED","15587","15685","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15689_15682_R","null","STREAMLINED","15682","15689","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15690_15710_R","null","STREAMLINED","15710","15690","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be one in which tetracycline therapy is inappropriate.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be one in which tetracycline therapy is inappropriate.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15694_15551_R","null","RESTRICTED","15551","15694","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15695_15696_R","null","RESTRICTED","15696","15695","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15697_15670_R","null","RESTRICTED","15670","15697","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15706_15726_R","null","RESTRICTED","15726","15706","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anorectal congenital abnormalities</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anorectal congenital abnormalities</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15712_15692_R","null","STREAMLINED","15692","15712","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">This drug is not recommended nor PBS-subsidised for use as &apos;maintenance and reliever&apos; therapy.</p> <p align=""justify"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15713_15604_R","null","STREAMLINED","15604","15713","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 4 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 4 years or older.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15716_15639_R","null","RESTRICTED","15639","15716","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depressive disorders</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depressive disorders</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15720_15754_R","null","STREAMLINED","15754","15720","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a respiratory physician, paediatric respiratory physician, clinical immunologist, allergist, paediatrician or general physician experienced in the management of patients with severe asthma; or in consultation with one of these specialists; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND</p> <p>Patient must have experienced at least one severe exacerbation prior to receiving PBS-subsidised treatment with this drug for this condition, which has required documented use of systemic corticosteroids in the previous 12 months while receiving optimised asthma therapy; or</p> <p>Patient must have experienced frequent episodes of moderate asthma exacerbations prior to receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of a medium to high dose ICS and a LABA. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a respiratory physician, paediatric respiratory physician, clinical immunologist, allergist, paediatrician or general physician experienced in the management of patients with severe asthma; or in consultation with one of these specialists; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND</p> <p>Patient must have experienced at least one severe exacerbation prior to receiving PBS-subsidised treatment with this drug for this condition, which has required documented use of systemic corticosteroids in the previous 12 months while receiving optimised asthma therapy; or</p> <p>Patient must have experienced frequent episodes of moderate asthma exacerbations prior to receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of a medium to high dose ICS and a LABA. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative</p> <p align=""justify"">Formal assessment and correction of inhaler technique should be performed in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique (available at www.humanservices.gov.au or www.nationalasthma.org.au); the assessment and adherence to correct technique should be documented in the patient&apos;s medical records. Patients can obtain support with inhaler technique through their local Asthma Foundation (1800 645 130).</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15721_15755_R","null","STREAMLINED","15755","15721","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15723_15736_R","null","RESTRICTED","15736","15723","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p> <p>This drug is not PBS-subsidised for the treatment of asthma.</p> <p align=""justify"">The treatment must not be used in combination with an ICS/LABA, or LAMA/LABA</p> <p align=""justify"">A LAMA/LABA includes aclidinium/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, or umeclidinium/vilanterol.</p> <p align=""justify"">An ICS/LABA includes budesonide/formoterol, fluticasone/salmeterol, or fluticasone/vilanterol</p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15728_15735_R","null","RESTRICTED","15735","15728","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Megacolon</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Megacolon</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15731_15693_R","null","STREAMLINED","15693","15731","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15740_15656_R","null","STREAMLINED","15656","15740","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 18 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 18 years or older.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15741_15661_R","null","RESTRICTED","15661","15741","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; AND</p> <p>The condition must be unresponsive to other oral therapies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; AND</p> <p>The condition must be unresponsive to other oral therapies.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15748_15546_R","null","STREAMLINED","15546","15748","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">This drug is not recommended nor PBS-subsidised for use as &apos;maintenance and reliever&apos; therapy.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15750_15714_R","null","STREAMLINED","15714","15750","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15752_15753_R","Long-term maintenance treatment","RESTRICTED","15753","15752","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease</p><br/><p>Long-term maintenance treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease</p><br/><p>Long-term maintenance treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p> <p align=""justify"">The treatment must not be used in combination with a LAMA/LABA or SAMA</p> <p align=""justify"">A LAMA/LABA includes aclidinium/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, or umeclidinium/vilanterol.</p> <p align=""justify"">A SAMA includes ipratropium</p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15758_15774_R","Initial treatment","STREAMLINED","15774","15758","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be each of: (i) classified as having an intermediate to poor survival risk score according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), (ii) untreated with a tyrosine kinase inhibitor; or</p> <p>Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) despite treatment with a tyrosine kinase inhibitor, irrespective of the current IMDC survival risk score; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be undergoing treatment with this drug for the first time at the time of the first PBS prescription.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be each of: (i) classified as having an intermediate to poor survival risk score according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), (ii) untreated with a tyrosine kinase inhibitor; or</p> <p>Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) despite treatment with a tyrosine kinase inhibitor, irrespective of the current IMDC survival risk score; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be undergoing treatment with this drug for the first time at the time of the first PBS prescription.</p> <p align=""justify""><i>A</i> prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk score can be calculated here: https://www.mdcalc.com/imdc-international-metastatic-rcc-database-consortium-risk-model-metastatic-renal-cell-carcinoma.</p><p align=""justify"">One point is assigned for each of:</p><p align=""justify"">(i) a time of diagnosis to systemic therapy of less than 1 year</p><p align=""justify"">(ii) a Karnofsky Performance Status of less than 80%</p><p align=""justify"">(iii) a haemoglobin less than the lower limit of normal</p><p align=""justify"">(iv) a corrected calcium level greater than the upper limit of normal</p><p align=""justify"">(v) a neutrophil count greater than the upper limit of normal</p><p align=""justify"">(vi) a platelet count greater than the upper limit of normal</p><p align=""justify"">Stated normal reference ranges may vary depending on the laboratory providing the measurement. &apos;Normal&apos; here refers to the individual laboratory&apos;s stated normal reference range.</p><p align=""justify"">Favourable IMDC risk is a score of 0.</p><p align=""justify"">Intermediate IMDC risk is a score of 1 to 2.</p><p align=""justify"">Poor IMDC risk is a score of 3 to 6.</p><p align=""justify"">Document any IMDC risk score assessment in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15760_15776_R","Initial treatment","AUTHORITY_REQUIRED","15776","15760","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; or</p> <p>Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; or</p> <p>Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-09-01","Y","4708"
"15769_15807_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","15807","15769","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment; AND</p> <p>Must be treated by a dermatologist.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15770_15781_R","Continuing treatment","AUTHORITY_REQUIRED","15781","15770","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solid tumours with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion</p><br/><p>Continuing treatment</p><br/><p>Patient must be undergoing continuing PBS-subsidised treatment commenced through an ''Initial treatment'' listing for solid tumours (of any type) with confirmed NTRK gene fusion where treatment with this drug is/was initiated in a child; or</p> <p>Patient must be undergoing continuing PBS-subsidised treatment commenced through an ''Initial treatment'' listing for solid tumours (of certain specified types) with confirmed NTRK gene fusion which either includes: (i) mammary analogue secretory carcinoma of the salivary gland, (ii) secretory breast carcinoma; AND</p> <p>The treatment must cease to be a PBS benefit upon radiographic progression; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.</p> <p align=""justify"">Where radiographic progression is observed, mark any remaining repeat prescriptions with the word &apos;cancelled&apos;.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solid tumours with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion</p><br/><p>Continuing treatment</p><br/><p>Patient must be undergoing continuing PBS-subsidised treatment commenced through an ''Initial treatment'' listing for solid tumours (of any type) with confirmed NTRK gene fusion where treatment with this drug is/was initiated in a child; or</p> <p>Patient must be undergoing continuing PBS-subsidised treatment commenced through an ''Initial treatment'' listing for solid tumours (of certain specified types) with confirmed NTRK gene fusion which either includes: (i) mammary analogue secretory carcinoma of the salivary gland, (ii) secretory breast carcinoma; AND</p> <p>The treatment must cease to be a PBS benefit upon radiographic progression; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.</p> <p align=""justify"">Where radiographic progression is observed, mark any remaining repeat prescriptions with the word &apos;cancelled&apos;.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15771_15814_R","null","STREAMLINED","15814","15771","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15773_15800_R","null","STREAMLINED","15800","15773","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15783_15784_R","null","STREAMLINED","15784","15783","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15785_15782_R","null","STREAMLINED","15782","15785","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15789_15788_R","Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years), or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","15788","15789","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years), or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A maximum of 12 weeks of treatment will be authorised under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years), or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A maximum of 12 weeks of treatment will be authorised under this restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15802_15759_R","Initial treatment","AUTHORITY_REQUIRED","15759","15802","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.</p>","N","N","N","IMMEDIATE","ALL","N","2024-09-01","N","4708"
"15821_15831_R","Initial treatment (weekly regimen)","STREAMLINED","15831","15821","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Initial treatment (weekly regimen)</p><br/><p>Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p> <p align=""justify"">HER2 positivity must be demonstrated by in situ hybridisation (ISH).</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Initial treatment (weekly regimen)</p><br/><p>Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p> <p align=""justify"">HER2 positivity must be demonstrated by in situ hybridisation (ISH).</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","N","N","N","IMMEDIATE","ALL","Y","2024-09-01","N","4708"
"15822_15820_R","Initial treatment (3 weekly regimen)","STREAMLINED","15820","15822","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Initial treatment (3 weekly regimen)</p><br/><p>Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p> <p align=""justify"">HER2 positivity must be demonstrated by in situ hybridisation (ISH).</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Initial treatment (3 weekly regimen)</p><br/><p>Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; or</p> <p>Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.</p> <p align=""justify"">HER2 positivity must be demonstrated by in situ hybridisation (ISH).</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","N","N","N","IMMEDIATE","ALL","Y","2024-09-01","N","4708"
"15823_15826_R","null","AUTHORITY_REQUIRED","15826","15823","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Patient must have evidence of human epidermal growth factor (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) in either the primary tumour/a metastatic lesion - establish this finding once only with the first PBS prescription; AND</p> <p>The condition must have progressed following treatment with at least one prior HER2 directed regimen for metastatic breast cancer; or</p> <p>The condition must have, at the time of treatment initiation with this drug, progressed during/within 6 months following adjuvant treatment with a HER2 directed therapy; AND</p> <p>Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only; AND</p> <p>Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; or</p> <p>Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions.</p> <p align=""justify"">Confirm that the following information is documented/retained in the patient&apos;s medical records once only with the first PBS prescription:</p><p align=""justify"">1) Evidence of HER2 gene amplification (evidence obtained in relation to past PBS treatment is acceptable).</p><p align=""justify"">2) Details of prior HER2 directed drug regimens prescribed for the patient.</p><p align=""justify"">3) Cardiac function test results (evidence obtained in relation to past PBS treatment is acceptable).</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Patient must have evidence of human epidermal growth factor (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) in either the primary tumour/a metastatic lesion - establish this finding once only with the first PBS prescription; AND</p> <p>The condition must have progressed following treatment with at least one prior HER2 directed regimen for metastatic breast cancer; or</p> <p>The condition must have, at the time of treatment initiation with this drug, progressed during/within 6 months following adjuvant treatment with a HER2 directed therapy; AND</p> <p>Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only; AND</p> <p>Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; or</p> <p>Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions.</p> <p align=""justify"">Confirm that the following information is documented/retained in the patient&apos;s medical records once only with the first PBS prescription:</p><p align=""justify"">1) Evidence of HER2 gene amplification (evidence obtained in relation to past PBS treatment is acceptable).</p><p align=""justify"">2) Details of prior HER2 directed drug regimens prescribed for the patient.</p><p align=""justify"">3) Cardiac function test results (evidence obtained in relation to past PBS treatment is acceptable).</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","N","N","N","IMMEDIATE","ALL","Y","2024-09-01","N","4708"
"15824_15827_R","Continuing treatment","AUTHORITY_REQUIRED","15827","15824","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for metastatic (Stage IV) HER2 positive breast cancer; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">The treatment must not exceed a lifetime total of one continuous course for this PBS indication.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for metastatic (Stage IV) HER2 positive breast cancer; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">The treatment must not exceed a lifetime total of one continuous course for this PBS indication.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","N","N","N","IMMEDIATE","ALL","Y","2024-09-01","N","4708"
"15825_15819_R","Continuing adjuvant treatment","AUTHORITY_REQUIRED","15819","15825","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Continuing adjuvant treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Continuing adjuvant treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","N","N","Y","IMMEDIATE","ALL","Y","2024-09-01","N","4708"
"15829_15818_R","Initial adjuvant treatment","AUTHORITY_REQUIRED","15818","15829","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Initial adjuvant treatment</p><br/><p>The treatment must be prescribed within 12 weeks after surgery; AND</p> <p>Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND</p> <p>Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.</p> <p align=""justify"">Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery.</p><p align=""justify"">The pathology report must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Initial adjuvant treatment</p><br/><p>The treatment must be prescribed within 12 weeks after surgery; AND</p> <p>Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND</p> <p>Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.</p> <p align=""justify"">Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery.</p><p align=""justify"">The pathology report must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","N","N","Y","FULL","ALL","Y","2024-09-01","Y","4708"
"15830_15832_R","null","AUTHORITY_REQUIRED","15832","15830","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable and/or metastatic HER2-low breast cancer</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2)-low disease; AND</p> <p>Patient must have received prior chemotherapy in the metastatic setting; or</p> <p>Patient must have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; AND</p> <p>Patient must have received or be ineligible for endocrine therapy in the metastatic setting, if hormone receptor positive; AND</p> <p>Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only; AND</p> <p>Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; or</p> <p>Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions.</p> <p align=""justify"">HER2-low is defined as an immunohistochemical (IHC) score of 1+ or an IHC score of 2+ and a negative result on in situ hybridization (ISH).</p> <p align=""justify"">Confirm that the following information is documented/retained in the patient&apos;s medical records once only with the first PBS prescription:</p><p align=""justify"">1) Evidence of HER2-low status</p><p align=""justify"">2) Details of prior drug regimens prescribed for the patient</p><p align=""justify"">3) Cardiac function test results</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable and/or metastatic HER2-low breast cancer</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2)-low disease; AND</p> <p>Patient must have received prior chemotherapy in the metastatic setting; or</p> <p>Patient must have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; AND</p> <p>Patient must have received or be ineligible for endocrine therapy in the metastatic setting, if hormone receptor positive; AND</p> <p>Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only; AND</p> <p>Patient must be undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; or</p> <p>Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions.</p> <p align=""justify"">HER2-low is defined as an immunohistochemical (IHC) score of 1+ or an IHC score of 2+ and a negative result on in situ hybridization (ISH).</p> <p align=""justify"">Confirm that the following information is documented/retained in the patient&apos;s medical records once only with the first PBS prescription:</p><p align=""justify"">1) Evidence of HER2-low status</p><p align=""justify"">2) Details of prior drug regimens prescribed for the patient</p><p align=""justify"">3) Cardiac function test results</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","N","N","N","IMMEDIATE","ALL","Y","2024-09-01","N","4708"
"15833_15828_R","Initial treatment","AUTHORITY_REQUIRED","15828","15833","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; or</p> <p>The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH).</p><p align=""justify"">(b) dates of treatment with trastuzumab and pertuzumab;</p><p align=""justify"">(c) date of demonstration of progression following treatment with trastuzumab and pertuzumab; or</p><p align=""justify"">(d) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment.</p><p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; or</p> <p>The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH).</p><p align=""justify"">(b) dates of treatment with trastuzumab and pertuzumab;</p><p align=""justify"">(c) date of demonstration of progression following treatment with trastuzumab and pertuzumab; or</p><p align=""justify"">(d) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment.</p><p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum amounts may only be authorised where a patient&apos;s weight is greater than 125 kg.</p>","N","N","N","IMMEDIATE","ALL","Y","2024-09-01","N","4708"
"15834_15892_R","Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply of first-line therapy","AUTHORITY_REQUIRED","15892","15834","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply of first-line therapy</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 October 2024; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The condition must have been untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line treatment of CLL/SLL at the time of receiving non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses).</p> <p>A patient may qualify for PBS-subsidised treatment under this restriction once only.</p> <p align=""justify"">For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the next relevant treatment phase.</p> <p align=""justify"">There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply of first-line therapy</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 October 2024; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The condition must have been untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line treatment of CLL/SLL at the time of receiving non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses).</p> <p>A patient may qualify for PBS-subsidised treatment under this restriction once only.</p> <p align=""justify"">For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the next relevant treatment phase.</p> <p align=""justify"">There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15).</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15835_15836_R","Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply of first-line therapy","AUTHORITY_REQUIRED","15836","15835","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply of first-line therapy</p><br/><p>Patient must have received non-PBS-subsidised treatment with ibrutinib for this condition prior to 1 October 2024; AND</p> <p>Patient must not have developed disease progression while receiving treatment for this condition; AND</p> <p>The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses).</p> <p>A patient may qualify for PBS-subsidised treatment under this restriction once only.</p> <p align=""justify"">For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the next relevant treatment phase.</p> <p align=""justify"">A patient may also qualify for treatment under this listing if they have previously received non-PBS-subsidised treatment with venetoclax for this condition prior to 1 October 2024 from Cycle 4.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply of first-line therapy</p><br/><p>Patient must have received non-PBS-subsidised treatment with ibrutinib for this condition prior to 1 October 2024; AND</p> <p>Patient must not have developed disease progression while receiving treatment for this condition; AND</p> <p>The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses).</p> <p>A patient may qualify for PBS-subsidised treatment under this restriction once only.</p> <p align=""justify"">For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the next relevant treatment phase.</p> <p align=""justify"">A patient may also qualify for treatment under this listing if they have previously received non-PBS-subsidised treatment with venetoclax for this condition prior to 1 October 2024 from Cycle 4.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15841_15923_R","Continuing treatment","AUTHORITY_REQUIRED","15923","15841","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the vedolizumab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose. </p> <p>Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the vedolizumab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose. </p> <p>Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15842_15909_R","Balance of supply","AUTHORITY_REQUIRED","15909","15842","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 3 doses therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 3 doses therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15843_15844_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","15844","15843","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A partial Mayo clinic assessment of the patient&apos;s response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A partial Mayo clinic assessment of the patient&apos;s response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15848_15849_R","Initial treatment - Initial 2 (Change of treatment)","AUTHORITY_REQUIRED","15849","15848","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND</p> <p>Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; or</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and</p><p align=""justify"">(b) details (date and duration of treatment) of prior biological medicine treatment; and</p><p align=""justify"">(c) eosinophil count and date; and</p><p align=""justify"">(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and</p><p align=""justify"">(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND</p> <p>Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; or</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and</p><p align=""justify"">(b) details (date and duration of treatment) of prior biological medicine treatment; and</p><p align=""justify"">(c) eosinophil count and date; and</p><p align=""justify"">(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and</p><p align=""justify"">(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","N","N","N","FULL","ALL","N","2024-10-01","Y","4708"
"15850_15947_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","15947","15850","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15855_15856_R","One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control","AUTHORITY_REQUIRED","15856","15855","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex gastro-oesophageal reflux disease (GORD)</p><br/><p>One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a surgeon with expertise in the upper gastrointestinal tract; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialists in relation to this current PBS benefit being sought, with the specialist''s name documented in the patient''s medical records for auditing purposes; or</p> <p>Must be treated by a medical practitioner who has not consulted a specialist, but only if treatment continues therapy initiated under this restriction with involvement by a specialist (i.e. continuing treatment initiated for non-complex GORD does not meet this criterion), with the specialist''s name documented in the patient''s medical records for auditing purposes; AND</p> <p>The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND</p> <p>Patient must must have symptoms inadequately controlled with each of: (i) a standard dose proton pump inhibitor (PPI) administered once daily, (ii) a low dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; or</p> <p>Patient must be assessed for the risks/benefits of a step-down in dosing from standard dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; or</p> <p>Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; or</p> <p>Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 2 packs per dispensing.</p> <p align=""justify"">Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex gastro-oesophageal reflux disease (GORD)</p><br/><p>One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a surgeon with expertise in the upper gastrointestinal tract; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialists in relation to this current PBS benefit being sought, with the specialist''s name documented in the patient''s medical records for auditing purposes; or</p> <p>Must be treated by a medical practitioner who has not consulted a specialist, but only if treatment continues therapy initiated under this restriction with involvement by a specialist (i.e. continuing treatment initiated for non-complex GORD does not meet this criterion), with the specialist''s name documented in the patient''s medical records for auditing purposes; AND</p> <p>The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND</p> <p>Patient must must have symptoms inadequately controlled with each of: (i) a standard dose proton pump inhibitor (PPI) administered once daily, (ii) a low dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; or</p> <p>Patient must be assessed for the risks/benefits of a step-down in dosing from standard dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; or</p> <p>Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; or</p> <p>Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 2 packs per dispensing.</p> <p align=""justify"">Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15857_15857_R","Initial 1 (new patient)","AUTHORITY_REQUIRED","15857","15857","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted for the purposes of administering this restriction can be found on the Services Australia website at www.servicesaustralia.gov.au</p> <p align=""justify"">For details on the appropriate minimum exercise program that will be accepted for the purposes of administering this restriction, please refer to the Services Australia website at www.servicesaustralia.gov.au</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15858_15891_R","Initial treatment - Initial 1 (New patient)","AUTHORITY_REQUIRED","15891","15858","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 1 (New patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""left"">The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The baseline BASDAI score and CRP level must also be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 1 (New patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""left"">The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The baseline BASDAI score and CRP level must also be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15860_15916_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","15916","15860","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15862_15864_R","Initial treatment in first-line therapy (treatment cycles 1 to 3 inclusive)","AUTHORITY_REQUIRED","15864","15862","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Initial treatment in first-line therapy (treatment cycles 1 to 3 inclusive)</p><br/><p>The condition must be untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses).</p> <p align=""justify"">There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Initial treatment in first-line therapy (treatment cycles 1 to 3 inclusive)</p><br/><p>The condition must be untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses).</p> <p align=""justify"">There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15).</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15867_15944_R","Initial treatment with subcutaneous form","AUTHORITY_REQUIRED","15944","15867","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment with subcutaneous form</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 1 (new patient); or</p> <p>Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years); or</p> <p>Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); or</p> <p>Patient must have a concurrent authority application for the intravenous infusion for this condition under either Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where two initial doses of vedolizumab (at weeks 0 and 2) are administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 6. The maximum listed quantity and 2 repeats should be requested to provide for weeks 6, 8, 10, 12, 14 and 16.</p> <p align=""justify"">Where three initial doses of vedolizumab (at weeks 0, 2 and 6) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 14 (8 weeks after the third dose). A maximum quantity with no repeats should be requested to provide for weeks 14 and 16.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment with subcutaneous form</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 1 (new patient); or</p> <p>Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years); or</p> <p>Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); or</p> <p>Patient must have a concurrent authority application for the intravenous infusion for this condition under either Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where two initial doses of vedolizumab (at weeks 0 and 2) are administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 6. The maximum listed quantity and 2 repeats should be requested to provide for weeks 6, 8, 10, 12, 14 and 16.</p> <p align=""justify"">Where three initial doses of vedolizumab (at weeks 0, 2 and 6) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 14 (8 weeks after the third dose). A maximum quantity with no repeats should be requested to provide for weeks 14 and 16.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15869_15933_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","15933","15869","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A partial Mayo clinic assessment of the patient&apos;s response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A partial Mayo clinic assessment of the patient&apos;s response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15874_15874_R","Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","15874","15874","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15876_9064_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","9064","15876","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15877_15903_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","15903","15877","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15879_15905_R","Initial treatment in first-line therapy with ibrutinib - Dose titration (cycle 4)","AUTHORITY_REQUIRED","15905","15879","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Initial treatment in first-line therapy with ibrutinib - Dose titration (cycle 4)</p><br/><p>The condition must be untreated with venetoclax at the time of the first dose of this drug; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Initial treatment in first-line therapy with ibrutinib - Dose titration (cycle 4)</p><br/><p>The condition must be untreated with venetoclax at the time of the first dose of this drug; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses).</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15883_15870_R","Initial treatment - Initial 2 (Change of treatment)","AUTHORITY_REQUIRED","15870","15883","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND</p> <p>Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.</p><p align=""justify"">At the time of the authority application, medical practitioners should request an appropriate maximum quantity based on IgE level and body weight (refer to the TGA-approved Product Information) to be administered every 2 to 4 weeks and up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and</p><p align=""justify"">(b) details (date and duration of treatment) of prior biological medicine treatment; and</p><p align=""justify"">(c) the IgE results and date; and</p><p align=""justify"">(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and</p><p align=""justify"">(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND</p> <p>Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.</p><p align=""justify"">At the time of the authority application, medical practitioners should request an appropriate maximum quantity based on IgE level and body weight (refer to the TGA-approved Product Information) to be administered every 2 to 4 weeks and up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and</p><p align=""justify"">(b) details (date and duration of treatment) of prior biological medicine treatment; and</p><p align=""justify"">(c) the IgE results and date; and</p><p align=""justify"">(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and</p><p align=""justify"">(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","N","N","N","FULL","ALL","N","2024-10-01","Y","4708"
"15885_15886_R","Initial treatment - Initial 2 (Change of treatment)","AUTHORITY_REQUIRED","15886","15885","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND</p> <p>Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; or</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; or</p> <p>Patient must have had a total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma, that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter.</p><p align=""justify"">A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and</p><p align=""justify"">(b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and</p><p align=""justify"">(c) if applicable, the eosinophil count and date; and</p><p align=""justify"">(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and</p><p align=""justify"">(e) if applicable, the IgE result and date; and</p><p align=""justify"">(f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND</p> <p>Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; or</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; or</p> <p>Patient must have had a total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma, that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter.</p><p align=""justify"">A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and</p><p align=""justify"">(b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and</p><p align=""justify"">(c) if applicable, the eosinophil count and date; and</p><p align=""justify"">(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and</p><p align=""justify"">(e) if applicable, the IgE result and date; and</p><p align=""justify"">(f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","N","N","N","FULL","ALL","N","2024-10-01","Y","4708"
"15889_15889_R","Initial treatment","STREAMLINED","15889","15889","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established atherosclerotic cardiovascular disease with hypertriglyceridaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must have at least one of (i) coronary artery disease, (ii) cerebrovascular or carotid disease, (iii) peripheral arterial disease; AND</p> <p>Patient must be treated with a stable dose of a HMG CoA reductase inhibitor (statin) to achieve target secondary prevention LDL-c levels for at least 12 consecutive weeks; or</p> <p>Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment; or</p> <p>Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND</p> <p>Patient must have LDL cholesterol level between 1.0 millimoles per litre and 2.6 millimoles per litre; or</p> <p>Patient must have a non-HDL cholesterol between 1.5 millimoles per litre and 3.5 millimoles per litre if LDL cannot be measured/detected; AND</p> <p>Patient must have fasting triglyceride level between 1.7 millimoles per litre and 5.6 millimoles per litre.</p> <p align=""justify"">The qualifying fasting triglyceride level and LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, dietary therapy and exercise should be documented in the patient&apos;s medical records and must be no more than 8 weeks old.</p> <p align=""justify"">A clinically important product-related adverse event is defined as follows: </p><p align=""justify"">(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or </p><p align=""justify"">(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or </p><p align=""justify"">(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.</p> <p align=""justify"">Atherosclerotic cardiovascular disease is defined as:</p><p align=""justify"">(i) Documented coronary artery disease (CAD); one or more of the following primary criteria must have been satisfied:</p><p align=""justify"">a) Documented multi-vessel CAD (at least 50% stenosis in at least two major epicardial coronary arteries, with or without antecedent revascularisation).</p><p align=""justify"">b) Documented prior MI.</p><p align=""justify"">c) Hospitalisation for high-risk non-ST-segment elevation acute coronary syndrome, with objective evidence of ischemia: ST-segment deviation or biomarker positivity.</p><p align=""justify"">(ii) Documented cerebrovascular or carotid disease; one of the following primary criteria must have been satisfied:</p><p align=""justify"">a) Documented prior ischemic stroke.</p><p align=""justify"">b) Symptomatic carotid artery disease with at least 50% carotid arterial stenosis.</p><p align=""justify"">c) Asymptomatic carotid artery disease with at least 70% carotid arterial stenosis per angiography or duplex ultrasound.</p><p align=""justify"">d) History of carotid revascularisation (catheter-based or surgical).</p><p align=""justify"">(iii) Documented peripheral arterial disease; one or more of the following primary criteria must have been satisfied:</p><p align=""justify"">a) Ankle brachial index (ABI) less than 0.9 with symptoms of intermittent claudication.</p><p align=""justify"">b) History of aorto-iliac or peripheral arterial intervention (catheter-based or surgical).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established atherosclerotic cardiovascular disease with hypertriglyceridaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must have at least one of (i) coronary artery disease, (ii) cerebrovascular or carotid disease, (iii) peripheral arterial disease; AND</p> <p>Patient must be treated with a stable dose of a HMG CoA reductase inhibitor (statin) to achieve target secondary prevention LDL-c levels for at least 12 consecutive weeks; or</p> <p>Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment; or</p> <p>Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND</p> <p>Patient must have LDL cholesterol level between 1.0 millimoles per litre and 2.6 millimoles per litre; or</p> <p>Patient must have a non-HDL cholesterol between 1.5 millimoles per litre and 3.5 millimoles per litre if LDL cannot be measured/detected; AND</p> <p>Patient must have fasting triglyceride level between 1.7 millimoles per litre and 5.6 millimoles per litre.</p> <p align=""justify"">The qualifying fasting triglyceride level and LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, dietary therapy and exercise should be documented in the patient&apos;s medical records and must be no more than 8 weeks old.</p> <p align=""justify"">A clinically important product-related adverse event is defined as follows: </p><p align=""justify"">(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or </p><p align=""justify"">(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or </p><p align=""justify"">(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.</p> <p align=""justify"">Atherosclerotic cardiovascular disease is defined as:</p><p align=""justify"">(i) Documented coronary artery disease (CAD); one or more of the following primary criteria must have been satisfied:</p><p align=""justify"">a) Documented multi-vessel CAD (at least 50% stenosis in at least two major epicardial coronary arteries, with or without antecedent revascularisation).</p><p align=""justify"">b) Documented prior MI.</p><p align=""justify"">c) Hospitalisation for high-risk non-ST-segment elevation acute coronary syndrome, with objective evidence of ischemia: ST-segment deviation or biomarker positivity.</p><p align=""justify"">(ii) Documented cerebrovascular or carotid disease; one of the following primary criteria must have been satisfied:</p><p align=""justify"">a) Documented prior ischemic stroke.</p><p align=""justify"">b) Symptomatic carotid artery disease with at least 50% carotid arterial stenosis.</p><p align=""justify"">c) Asymptomatic carotid artery disease with at least 70% carotid arterial stenosis per angiography or duplex ultrasound.</p><p align=""justify"">d) History of carotid revascularisation (catheter-based or surgical).</p><p align=""justify"">(iii) Documented peripheral arterial disease; one or more of the following primary criteria must have been satisfied:</p><p align=""justify"">a) Ankle brachial index (ABI) less than 0.9 with symptoms of intermittent claudication.</p><p align=""justify"">b) History of aorto-iliac or peripheral arterial intervention (catheter-based or surgical).</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15894_15894_R","Induction treatment","AUTHORITY_REQUIRED","15894","15894","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis</p><br/><p>Induction treatment</p><br/><p>The condition must be severe granulomatosis with polyangiitis; or</p> <p>The condition must be severe microscopic polyangiitis; AND</p> <p>The condition must be active at the time of the first prescription for this drug per treatment cycle; AND</p> <p>Patient must have ANCA associated vasculitis that is either: (i) organ-threatening, (ii) life-threatening disease; AND</p> <p>Patient must be undergoing concomitant therapy with at least another drug therapy as part of a regimen specified in this drug''s approved Product Information; AND</p> <p>Patient must not receive more than 12 months of PBS-subsidised treatment with this drug per induction.</p> <p align=""justify"">A prescriber may apply for more than one induction treatment for their patient</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis</p><br/><p>Induction treatment</p><br/><p>The condition must be severe granulomatosis with polyangiitis; or</p> <p>The condition must be severe microscopic polyangiitis; AND</p> <p>The condition must be active at the time of the first prescription for this drug per treatment cycle; AND</p> <p>Patient must have ANCA associated vasculitis that is either: (i) organ-threatening, (ii) life-threatening disease; AND</p> <p>Patient must be undergoing concomitant therapy with at least another drug therapy as part of a regimen specified in this drug''s approved Product Information; AND</p> <p>Patient must not receive more than 12 months of PBS-subsidised treatment with this drug per induction.</p> <p align=""justify"">A prescriber may apply for more than one induction treatment for their patient</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15897_5710_R","null","STREAMLINED","5710","15897","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic Paget disease of bone</p> <p>Only 1 treatment each year per patient will be PBS-subsidised</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic Paget disease of bone</p> <p>Only 1 treatment each year per patient will be PBS-subsidised</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15898_6308_R","null","STREAMLINED","6308","15898","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition; AND</p> <p>Patient must not receive more than one PBS-subsidised treatment per year.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition; AND</p> <p>Patient must not receive more than one PBS-subsidised treatment per year.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15898_C","null","null","null","null","null","<p align=""justify"">Progressive multifocal leukoencephalopathy has been reported with this drug.</p>","N","Y","N","null","null","N","2016-04-01","N","4708"
"15899_15936_R","One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control","AUTHORITY_REQUIRED","15936","15899","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex gastro-oesophageal reflux disease (GORD)</p><br/><p>One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a surgeon with expertise in the upper gastrointestinal tract; AND</p> <p>The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND</p> <p>Patient must have symptoms inadequately controlled with each of: (i) a high dose proton pump inhibitor (PPI) administered once daily, (ii) a standard dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; or</p> <p>Patient must be assessed for the risks/benefits of a step-down in dosing from a high dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; or</p> <p>Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; or</p> <p>Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 2 packs per dispensing.</p> <p align=""justify"">Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex gastro-oesophageal reflux disease (GORD)</p><br/><p>One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a surgeon with expertise in the upper gastrointestinal tract; AND</p> <p>The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND</p> <p>Patient must have symptoms inadequately controlled with each of: (i) a high dose proton pump inhibitor (PPI) administered once daily, (ii) a standard dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; or</p> <p>Patient must be assessed for the risks/benefits of a step-down in dosing from a high dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; or</p> <p>Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; or</p> <p>Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 2 packs per dispensing.</p> <p align=""justify"">Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15900_15940_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","15940","15900","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15901_15902_R","Continuing treatment","AUTHORITY_REQUIRED","15902","15901","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15911_15884_R","Initial treatment - Initial 2 (Change of treatment)","AUTHORITY_REQUIRED","15884","15911","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND</p> <p>Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; or</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course sufficient for up to 32 weeks of therapy, based on a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter (refer to the TGA-approved Product Information).</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and</p><p align=""justify"">(b) details (date and duration of treatment) of prior biological medicine treatment; and</p><p align=""justify"">(c) eosinophil count and date; and</p><p align=""justify"">(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and</p><p align=""justify"">(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND</p> <p>Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; or</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course sufficient for up to 32 weeks of therapy, based on a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter (refer to the TGA-approved Product Information).</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and</p><p align=""justify"">(b) details (date and duration of treatment) of prior biological medicine treatment; and</p><p align=""justify"">(c) eosinophil count and date; and</p><p align=""justify"">(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and</p><p align=""justify"">(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","N","N","N","FULL","ALL","N","2024-10-01","Y","4708"
"15912_15888_R","Continuing treatment","AUTHORITY_REQUIRED","15888","15912","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15913_6313_R","null","STREAMLINED","6313","15913","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition; AND</p> <p>Patient must not receive more than one PBS-subsidised treatment per year.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition; AND</p> <p>Patient must not receive more than one PBS-subsidised treatment per year.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15914_6318_R","null","STREAMLINED","6318","15914","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition; AND</p> <p>Patient must not receive more than one PBS-subsidised treatment per year.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition; AND</p> <p>Patient must not receive more than one PBS-subsidised treatment per year.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15920_15904_R","Second and final continuing treatment prescription (treatment cycles 10 to 15 inclusive) of first-line therapy","AUTHORITY_REQUIRED","15904","15920","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Second and final continuing treatment prescription (treatment cycles 10 to 15 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses); AND</p> <p>The treatment must cease upon disease progression; or</p> <p>The treatment must cease upon completion of 12 cycles of treatment with this drug for this condition, whichever comes first.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Second and final continuing treatment prescription (treatment cycles 10 to 15 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses); AND</p> <p>The treatment must cease upon disease progression; or</p> <p>The treatment must cease upon completion of 12 cycles of treatment with this drug for this condition, whichever comes first.</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15922_15910_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","15910","15922","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition if relevant; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose. </p> <p>Up to a maximum of 2 repeats will be authorised.</p> <p>Authority approval for sufficient therapy to complete a maximum of 3 initial doses of treatment may be requested by telephone by contacting the Department of Human Services.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition if relevant; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose. </p> <p>Up to a maximum of 2 repeats will be authorised.</p> <p>Authority approval for sufficient therapy to complete a maximum of 3 initial doses of treatment may be requested by telephone by contacting the Department of Human Services.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15925_15946_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","15946","15925","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15927_15927_R","Continuing treatment","STREAMLINED","15927","15927","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established atherosclerotic cardiovascular disease with hypertriglyceridaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>The treatment must be co-administered with a HMG CoA reductase inhibitor (statin), unless the patient is contraindicated to statins or has developed statin related adverse events necessitating withdrawal of statin treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established atherosclerotic cardiovascular disease with hypertriglyceridaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>The treatment must be co-administered with a HMG CoA reductase inhibitor (statin), unless the patient is contraindicated to statins or has developed statin related adverse events necessitating withdrawal of statin treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15929_15907_R","First continuing treatment (treatment cycles 5 to 9 inclusive) of first-line therapy","AUTHORITY_REQUIRED","15907","15929","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First continuing treatment (treatment cycles 5 to 9 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses); AND</p> <p>The treatment must cease upon disease progression.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First continuing treatment (treatment cycles 5 to 9 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with ibrutinib (refer to Product Information for timing of ibrutinib and venetoclax doses); AND</p> <p>The treatment must cease upon disease progression.</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15932_15943_R","Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form","AUTHORITY_REQUIRED","15943","15932","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the intravenous form as their most recent course of PBS-subsidised biological medicine for this condition under the vedolizumab intravenous form continuing treatment restriction; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the intravenous form as their most recent course of PBS-subsidised biological medicine for this condition under the vedolizumab intravenous form continuing treatment restriction; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15934_15887_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","15887","15934","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15935_15926_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","15926","15935","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15937_15937_R","Continuing treatment","AUTHORITY_REQUIRED","15937","15937","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15938_15938_R","Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","15938","15938","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15939_15939_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","15939","15939","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15941_15918_R","Initial treatment","AUTHORITY_REQUIRED","15918","15941","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to age-related macular degeneration (AMD); AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to age-related macular degeneration (AMD); AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","N","N","N","FULL","ALL","N","2024-10-01","Y","4708"
"15945_15851_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","15851","15945","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy).</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy).</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-10-01","Y","4708"
"15948_15854_R","null","STREAMLINED","15854","15948","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The treatment must not be a PBS benefit where this 50 microgram strength is being initiated in a patient over the age of 6.00 years; AND</p> <p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The treatment must not be a PBS benefit where this 50 microgram strength is being initiated in a patient over the age of 6.00 years; AND</p> <p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15949_15949_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","15949","15949","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-10-01","N","4708"
"15954_16024_R","Initial treatment","STREAMLINED","16024","15954","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting; AND</p> <p>The condition must be active; AND</p> <p>Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND</p> <p>The treatment must be after failure of other therapy including dopamine agonists; or</p> <p>The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or</p> <p>The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised pegvisomant.</p> <p align=""justify"">In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting; AND</p> <p>The condition must be active; AND</p> <p>Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND</p> <p>The treatment must be after failure of other therapy including dopamine agonists; or</p> <p>The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or</p> <p>The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised pegvisomant.</p> <p align=""justify"">In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. </p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15955_15955_R","Continuing treatment","STREAMLINED","15955","15955","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months'' therapy at a dose of 120 mg every 28 days.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months'' therapy at a dose of 120 mg every 28 days.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15956_15956_R","null","RESTRICTED","15956","15956","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For prescribing by certain health practitioners</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For prescribing by certain health practitioners</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15957_4269_R","null","STREAMLINED","4269","15957","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of stroke or systemic embolism</p><br/><p>Patient must have non-valvular atrial fibrillation; AND</p> <p>Patient must have one or more risk factors for developing stroke or systemic embolism.</p> <p align=""justify"">Risk factors for developing stroke or systemic ischaemic embolism are:</p><p align=""justify"">(i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism;</p><p align=""justify"">(ii) age 75 years or older;</p><p align=""justify"">(iii) hypertension;</p><p align=""justify"">(iv) diabetes mellitus;</p><p align=""justify"">(v) heart failure and/or left ventricular ejection fraction 35% or less.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of stroke or systemic embolism</p><br/><p>Patient must have non-valvular atrial fibrillation; AND</p> <p>Patient must have one or more risk factors for developing stroke or systemic embolism.</p> <p align=""justify"">Risk factors for developing stroke or systemic ischaemic embolism are:</p><p align=""justify"">(i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism;</p><p align=""justify"">(ii) age 75 years or older;</p><p align=""justify"">(iii) hypertension;</p><p align=""justify"">(iv) diabetes mellitus;</p><p align=""justify"">(v) heart failure and/or left ventricular ejection fraction 35% or less.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15958_14301_R","null","STREAMLINED","14301","15958","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of stroke or systemic embolism</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have non-valvular atrial fibrillation; AND</p> <p>Patient must have one or more risk factors for developing stroke or systemic embolism.</p> <p align=""justify"">Risk factors for developing stroke or systemic ischaemic embolism are:</p><p align=""justify"">(i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism;</p><p align=""justify"">(ii) age 75 years or older;</p><p align=""justify"">(iii) hypertension;</p><p align=""justify"">(iv) diabetes mellitus;</p><p align=""justify"">(v) heart failure and/or left ventricular ejection fraction 35% or less.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of stroke or systemic embolism</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have non-valvular atrial fibrillation; AND</p> <p>Patient must have one or more risk factors for developing stroke or systemic embolism.</p> <p align=""justify"">Risk factors for developing stroke or systemic ischaemic embolism are:</p><p align=""justify"">(i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism;</p><p align=""justify"">(ii) age 75 years or older;</p><p align=""justify"">(iii) hypertension;</p><p align=""justify"">(iv) diabetes mellitus;</p><p align=""justify"">(v) heart failure and/or left ventricular ejection fraction 35% or less.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15959_5781_R","null","STREAMLINED","5781","15959","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing major hip surgery.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing major hip surgery.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15960_5808_R","null","STREAMLINED","5808","15960","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total knee replacement.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total knee replacement.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15961_14240_R","null","STREAMLINED","14240","15961","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute coronary syndrome (myocardial infarction or unstable angina)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be in combination with aspirin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute coronary syndrome (myocardial infarction or unstable angina)</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be in combination with aspirin.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15962_16111_R","null","STREAMLINED","16111","15962","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Angina</p><br/><p>The condition must not be responding to other therapy; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Angina</p><br/><p>The condition must not be responding to other therapy; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15963_6254_R","null","RESTRICTED","6254","15963","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Granulomata</p><br/><p>The condition must be dermal.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Granulomata</p><br/><p>The condition must be dermal.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15968_16029_R","null","RESTRICTED","16029","15968","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Septicaemia, proven</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Septicaemia, proven</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15969_15964_R","null","RESTRICTED","15964","15969","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15970_16030_R","null","RESTRICTED","16030","15970","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Septicaemia, suspected</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Septicaemia, suspected</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15971_16114_R","null","STREAMLINED","16114","15971","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fungal infection</p><br/><p>The condition must be serious or life-threatening; AND</p> <p>Patient must be unable to take a solid dose form of fluconazole; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fungal infection</p><br/><p>The condition must be serious or life-threatening; AND</p> <p>Patient must be unable to take a solid dose form of fluconazole; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15972_15979_R","Treatment and maintenance therapy","AUTHORITY_REQUIRED","15979","15972","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious Candida infections</p><br/><p>Treatment and maintenance therapy</p><br/><p>The condition must be caused by species not susceptible to fluconazole; or</p> <p>The condition must be resistant to fluconazole; or</p> <p>Patient must be unable to tolerate fluconazole; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious Candida infections</p><br/><p>Treatment and maintenance therapy</p><br/><p>The condition must be caused by species not susceptible to fluconazole; or</p> <p>The condition must be resistant to fluconazole; or</p> <p>Patient must be unable to tolerate fluconazole; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15974_15975_R","null","STREAMLINED","15975","15974","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cryptococcal meningitis</p><br/><p>The treatment must be maintenance therapy; AND</p> <p>Patient must be immunosuppressed; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cryptococcal meningitis</p><br/><p>The treatment must be maintenance therapy; AND</p> <p>Patient must be immunosuppressed; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15976_16073_R","null","STREAMLINED","16073","15976","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oropharyngeal candidiasis</p><br/><p>Patient must be immunosuppressed; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oropharyngeal candidiasis</p><br/><p>Patient must be immunosuppressed; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15977_16102_R","null","STREAMLINED","16102","15977","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oesophageal candidiasis</p><br/><p>Patient must be immunosuppressed; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oesophageal candidiasis</p><br/><p>Patient must be immunosuppressed; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15980_16115_R","null","AUTHORITY_REQUIRED","16115","15980","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prophylaxis of invasive fungal infections including both yeasts and moulds</p><br/><p>Patient must be considered at high risk of developing an invasive fungal infection due to anticipated neutropenia (an absolute neutrophil count less than 500 cells per cubic millimetre) for at least 10 days whilst receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome; or</p> <p>Patient must be considered at high risk of developing an invasive fungal infection due to having acute graft versus host disease (GVHD) grade II, III or IV, or, extensive chronic GVHD, whilst receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant; or</p> <p>Patient must be undergoing allogeneic haematopoietic stem cell transplant using either bone marrow from an unrelated donor or umbilical cord blood (related or unrelated), and, be considered to be at high risk of developing an invasive fungal infection during the neutropenic phase prior to engraftment; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prophylaxis of invasive fungal infections including both yeasts and moulds</p><br/><p>Patient must be considered at high risk of developing an invasive fungal infection due to anticipated neutropenia (an absolute neutrophil count less than 500 cells per cubic millimetre) for at least 10 days whilst receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome; or</p> <p>Patient must be considered at high risk of developing an invasive fungal infection due to having acute graft versus host disease (GVHD) grade II, III or IV, or, extensive chronic GVHD, whilst receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant; or</p> <p>Patient must be undergoing allogeneic haematopoietic stem cell transplant using either bone marrow from an unrelated donor or umbilical cord blood (related or unrelated), and, be considered to be at high risk of developing an invasive fungal infection during the neutropenic phase prior to engraftment; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15982_6023_R","null","STREAMLINED","6023","15982","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oropharyngeal candidiasis</p><br/><p>Patient must be immunosuppressed.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oropharyngeal candidiasis</p><br/><p>Patient must be immunosuppressed.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15983_5989_R","null","STREAMLINED","5989","15983","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oesophageal candidiasis</p><br/><p>Patient must be immunosuppressed.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oesophageal candidiasis</p><br/><p>Patient must be immunosuppressed.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15983_N","null","null","null","null","null","<p>Pharmaceutical benefits that have the form perindopril erbumine 8 mg tablet and pharmaceutical benefits that have the form perindopril arginine 10 mg tablet are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"15984_N","null","null","null","null","null","<p>Pharmaceutical benefits that have the form perindopril erbumine 2 mg tablet and pharmaceutical benefits that have the form perindopril arginine 2.5 mg tablet are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"15985_N","null","null","null","null","null","<p>Pharmaceutical benefits that have the form perindopril erbumine 4 mg tablet and pharmaceutical benefits that have the form perindopril arginine 5 mg tablet are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"15986_N","null","null","null","null","null","<p>Pharmaceutical benefits that have the form ramipril 1.25 mg tablet and pharmaceutical benefits that have the form ramipril 1.25 mg capsule are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"15987_16045_R","Use in a patient untreated with disease modifying therapies for this condition","AUTHORITY_REQUIRED","16045","15987","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Use in a patient untreated with disease modifying therapies for this condition</p><br/><p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>The condition must be pre-symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; AND</p> <p>The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND</p> <p>Patient must not be undergoing treatment with this pharmaceutical benefit through this listing where prior treatment has occurred with any of: (i) nusinersen, (ii) risdiplam; AND</p> <p>Patient must be no older than 9 months of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.</p><p align=""justify"">Confirm that genetic testing has been completed to demonstrate the following in support of an SMA diagnosis:</p><p align=""justify"">(i) 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p><p align=""justify"">(ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.</p><p align=""justify"">Confirm that there is a genetic test finding that substantiates the number of SMN2 gene copies to be 3 and has been determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).</p><p align=""justify"">Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Use in a patient untreated with disease modifying therapies for this condition</p><br/><p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>The condition must be pre-symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; AND</p> <p>The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND</p> <p>Patient must not be undergoing treatment with this pharmaceutical benefit through this listing where prior treatment has occurred with any of: (i) nusinersen, (ii) risdiplam; AND</p> <p>Patient must be no older than 9 months of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.</p><p align=""justify"">Confirm that genetic testing has been completed to demonstrate the following in support of an SMA diagnosis:</p><p align=""justify"">(i) 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p><p align=""justify"">(ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.</p><p align=""justify"">Confirm that there is a genetic test finding that substantiates the number of SMN2 gene copies to be 3 and has been determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).</p><p align=""justify"">Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient.</p> <p align=""justify"">An outcome on the authority application is not immediate, but will follow in due course. Electronic upload is encouraged to reduce processing time.</p>","N","N","N","FULL","ALL","N","2024-11-01","Y","4708"
"15987_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form ramipril 10 mg tablet and pharmaceutical benefits that have the form ramipril 10 mg capsule are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"15988_15989_R","Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec)","AUTHORITY_REQUIRED","15989","15988","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec)</p><br/><p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit with the intent that treatment with the replaced disease modifying agent is/has ceased; AND</p> <p>Patient must be no older than 9 months of age; AND</p> <p>Patient must have pre-symptomatic SMA with 3 copies of the SMN2 gene.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.</p><p align=""justify"">Confirm that a previous PBS authority application has been approved for pre-symptomatic SMA with 3 copies of SMN2 gene.</p><p align=""justify"">State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.</p> <p align=""justify"">Adhere to any Product Information or local treatment guidelines with respect to treatment-free (&apos;wash out&apos;) periods prior to administering this benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec)</p><br/><p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit with the intent that treatment with the replaced disease modifying agent is/has ceased; AND</p> <p>Patient must be no older than 9 months of age; AND</p> <p>Patient must have pre-symptomatic SMA with 3 copies of the SMN2 gene.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.</p><p align=""justify"">Confirm that a previous PBS authority application has been approved for pre-symptomatic SMA with 3 copies of SMN2 gene.</p><p align=""justify"">State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.</p> <p align=""justify"">Adhere to any Product Information or local treatment guidelines with respect to treatment-free (&apos;wash out&apos;) periods prior to administering this benefit.</p> <p align=""justify"">An outcome on the authority application is not immediate, but will follow in due course. Electronic upload is encouraged to reduce processing time.</p>","N","N","N","FULL","ALL","N","2024-11-01","Y","4708"
"15988_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form ramipril 2.5 mg tablet and pharmaceutical benefits that have the form ramipril 2.5 mg capsule are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"15989_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form ramipril 5 mg tablet and pharmaceutical benefits that have the form ramipril 5 mg capsule are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"15991_8921_R","null","STREAMLINED","8921","15991","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic gout</p><br/><p>The condition must be either chronic gouty arthritis or chronic tophaceous gout; AND</p> <p>Patient must have a medical contraindication to allopurinol; or</p> <p>Patient must have a documented history of allopurinol hypersensitivity syndrome; or</p> <p>Patient must have an intolerance to allopurinol necessitating permanent treatment discontinuation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic gout</p><br/><p>The condition must be either chronic gouty arthritis or chronic tophaceous gout; AND</p> <p>Patient must have a medical contraindication to allopurinol; or</p> <p>Patient must have a documented history of allopurinol hypersensitivity syndrome; or</p> <p>Patient must have an intolerance to allopurinol necessitating permanent treatment discontinuation.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15992_5522_R","null","RESTRICTED","5522","15992","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Breast cancer</p><br/><p>The condition must be hormone receptor positive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Breast cancer</p><br/><p>The condition must be hormone receptor positive.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15995_15996_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months","STREAMLINED","15996","15995","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must not be opioid naive; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must not be opioid naive; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2024-11-01","N","4708"
"15997_6027_R","Continuing treatment","AUTHORITY_REQUIRED","6027","15997","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Breakthrough pain</p><br/><p>Continuing treatment</p><br/><p>Patient must have cancer; AND</p> <p>Patient must have pain directly attributable to cancer; AND</p> <p>Patient must be assessed as receiving adequate management of their persistent pain with opioids; AND</p> <p>Patient must have previously experienced inadequate pain relief following adequate doses of short acting opioids for the treatment of breakthrough pain; or</p> <p>The treatment must be used as short acting opioids are considered clinically inappropriate; or</p> <p>Patient must have previously experienced adverse effects following the use of short acting opioids for breakthrough pain; AND</p> <p>Patient must be undergoing palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Breakthrough pain</p><br/><p>Continuing treatment</p><br/><p>Patient must have cancer; AND</p> <p>Patient must have pain directly attributable to cancer; AND</p> <p>Patient must be assessed as receiving adequate management of their persistent pain with opioids; AND</p> <p>Patient must have previously experienced inadequate pain relief following adequate doses of short acting opioids for the treatment of breakthrough pain; or</p> <p>The treatment must be used as short acting opioids are considered clinically inappropriate; or</p> <p>Patient must have previously experienced adverse effects following the use of short acting opioids for breakthrough pain; AND</p> <p>Patient must be undergoing palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"15998_16000_R","Continuing PBS treatment after 1 June 2020","STREAMLINED","16000","15998","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) is less than 12 months; or</p><p align=""justify"">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Continuing PBS treatment after 1 June 2020</p><br/><p>Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) is less than 12 months; or</p><p align=""justify"">(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(iii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iv) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2024-11-01","N","4708"
"15999_15994_R","Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months","STREAMLINED","15994","15999","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must not be opioid naive; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(ii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iii) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months</p><br/><p>The condition must require daily, continuous, long term opioid treatment; AND</p> <p>Patient must not be opioid naive; AND</p> <p>Patient must have cancer pain; or</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p> <p align=""justify"">Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment:</p><p align=""justify"">(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or</p><p align=""justify"">(ii) exceeds 12 months and the patient&apos;s clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or</p><p align=""justify"">(iii) has exceeded 12 months prior to 1 June 2020 and the patient&apos;s clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.</p> <p align=""justify"">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align=""justify"">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>","N","N","N","IMMEDIATE","ALL","Y","2024-11-01","N","4708"
"16001_6026_R","Initial treatment for dose titration","AUTHORITY_REQUIRED","6026","16001","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Breakthrough pain</p><br/><p>Initial treatment for dose titration</p><br/><p>Patient must have cancer; AND</p> <p>Patient must have pain directly attributable to cancer; AND</p> <p>Patient must be assessed as receiving adequate management of their persistent pain with opioids; AND</p> <p>Patient must have previously experienced inadequate pain relief following adequate doses of short acting opioids for the treatment of breakthrough pain; or</p> <p>The treatment must be used as short acting opioids are considered clinically inappropriate; or</p> <p>Patient must have previously experienced adverse effects following the use of short acting opioids for breakthrough pain; AND</p> <p>Patient must be undergoing palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Breakthrough pain</p><br/><p>Initial treatment for dose titration</p><br/><p>Patient must have cancer; AND</p> <p>Patient must have pain directly attributable to cancer; AND</p> <p>Patient must be assessed as receiving adequate management of their persistent pain with opioids; AND</p> <p>Patient must have previously experienced inadequate pain relief following adequate doses of short acting opioids for the treatment of breakthrough pain; or</p> <p>The treatment must be used as short acting opioids are considered clinically inappropriate; or</p> <p>Patient must have previously experienced adverse effects following the use of short acting opioids for breakthrough pain; AND</p> <p>Patient must be undergoing palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16002_5869_R","null","STREAMLINED","5869","16002","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bipolar I disorder</p><br/><p>The treatment must be maintenance therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bipolar I disorder</p><br/><p>The treatment must be maintenance therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16003_5773_R","null","STREAMLINED","5773","16003","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute mania or mixed episodes</p><br/><p>The condition must be associated with bipolar I disorder; AND</p> <p>The treatment must be limited to up to 6 months per episode.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute mania or mixed episodes</p><br/><p>The condition must be associated with bipolar I disorder; AND</p> <p>The treatment must be limited to up to 6 months per episode.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16004_4246_R","null","STREAMLINED","4246","16004","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16005_5907_R","null","STREAMLINED","5907","16005","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute mania</p><br/><p>The condition must be associated with bipolar I disorder; AND</p> <p>The treatment must be as adjunctive therapy to mood stabilisers; AND</p> <p>The treatment must be limited to up to 6 months per episode.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute mania</p><br/><p>The condition must be associated with bipolar I disorder; AND</p> <p>The treatment must be as adjunctive therapy to mood stabilisers; AND</p> <p>The treatment must be limited to up to 6 months per episode.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16006_5611_R","null","STREAMLINED","5611","16006","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute mania</p><br/><p>The condition must be associated with bipolar I disorder; AND</p> <p>The treatment must be as monotherapy; AND</p> <p>The treatment must be limited to up to 6 months per episode.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute mania</p><br/><p>The condition must be associated with bipolar I disorder; AND</p> <p>The treatment must be as monotherapy; AND</p> <p>The treatment must be limited to up to 6 months per episode.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16007_16048_R","Continuing treatment","STREAMLINED","16048","16007","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe behavioural disturbances</p><br/><p>Continuing treatment</p><br/><p>Patient must have autism spectrum disorder; AND</p> <p>Patient must have been commenced on PBS-subsidised treatment with risperidone prior to turning 18 years of age; AND</p> <p>The treatment must be under the supervision of a paediatrician or psychiatrist; AND</p> <p>The treatment must be in combination with non-pharmacological measures; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.</p> <p align=""justify"">The diagnosis of autism spectrum disorder must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD-10 international classification of mental and behavioural disorders.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe behavioural disturbances</p><br/><p>Continuing treatment</p><br/><p>Patient must have autism spectrum disorder; AND</p> <p>Patient must have been commenced on PBS-subsidised treatment with risperidone prior to turning 18 years of age; AND</p> <p>The treatment must be under the supervision of a paediatrician or psychiatrist; AND</p> <p>The treatment must be in combination with non-pharmacological measures; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.</p> <p align=""justify"">The diagnosis of autism spectrum disorder must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD-10 international classification of mental and behavioural disorders.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16008_16050_R","null","STREAMLINED","16050","16008","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Opioid dependence</p><br/><p>Must be treated by a health care professional; AND</p> <p>The treatment must be within a framework of medical, social and psychological treatment; AND</p> <p>Patient must be stabilised on sublingual buprenorphine or buprenorphine/naloxone prior to commencing treatment with this drug for this condition.</p> <p align=""justify"">The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient&apos;s needs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Opioid dependence</p><br/><p>Must be treated by a health care professional; AND</p> <p>The treatment must be within a framework of medical, social and psychological treatment; AND</p> <p>Patient must be stabilised on sublingual buprenorphine or buprenorphine/naloxone prior to commencing treatment with this drug for this condition.</p> <p align=""justify"">The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient&apos;s needs.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16010_5491_R","Maintenance following initiation and stabilisation","STREAMLINED","5491","16010","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>Maintenance following initiation and stabilisation</p><br/><p>The condition must not be adequately controlled by calcium; AND</p> <p>Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or</p> <p>The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND</p> <p>The treatment must not be used in combination with any other non-calcium phosphate binding agents; AND</p> <p>Patient must be undergoing dialysis for chronic kidney disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>Maintenance following initiation and stabilisation</p><br/><p>The condition must not be adequately controlled by calcium; AND</p> <p>Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or</p> <p>The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND</p> <p>The treatment must not be used in combination with any other non-calcium phosphate binding agents; AND</p> <p>Patient must be undergoing dialysis for chronic kidney disease.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16011_16015_R","null","STREAMLINED","16015","16011","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Opioid dependence</p><br/><p>Must be treated by a health care professional; AND</p> <p>The treatment must be within a framework of medical, social and psychological treatment; AND</p> <p>Patient must be stabilised on one of the following prior to commencing treatment with this drug for this condition: (i) weekly prolonged release buprenorphine (Buvidal Weekly) (ii) sublingual buprenorphine (iii) buprenorphine/naloxone.</p> <p align=""justify"">The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient&apos;s needs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Opioid dependence</p><br/><p>Must be treated by a health care professional; AND</p> <p>The treatment must be within a framework of medical, social and psychological treatment; AND</p> <p>Patient must be stabilised on one of the following prior to commencing treatment with this drug for this condition: (i) weekly prolonged release buprenorphine (Buvidal Weekly) (ii) sublingual buprenorphine (iii) buprenorphine/naloxone.</p> <p align=""justify"">The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient&apos;s needs.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16012_16009_R","null","STREAMLINED","16009","16012","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Opioid dependence</p><br/><p>The treatment must be within a framework of medical, social and psychological treatment.</p> <p align=""justify"">The prescriber must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient&apos;s daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient&apos;s needs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Opioid dependence</p><br/><p>The treatment must be within a framework of medical, social and psychological treatment.</p> <p align=""justify"">The prescriber must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient&apos;s daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient&apos;s needs.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16013_14872_R","Maintenance following initiation and stabilisation","STREAMLINED","14872","16013","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>Maintenance following initiation and stabilisation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must not be adequately controlled by calcium; AND</p> <p>Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or</p> <p>The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND</p> <p>The treatment must not be used in combination with any other non-calcium phosphate binding agents; AND</p> <p>Patient must be undergoing dialysis for chronic kidney disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>Maintenance following initiation and stabilisation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must not be adequately controlled by calcium; AND</p> <p>Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or</p> <p>The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND</p> <p>The treatment must not be used in combination with any other non-calcium phosphate binding agents; AND</p> <p>Patient must be undergoing dialysis for chronic kidney disease.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16014_16083_R","null","STREAMLINED","16083","16014","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Opioid dependence</p><br/><p>The treatment must be within a framework of medical, social and psychological treatment.</p> <p align=""justify"">The prescriber must request a quantity (in millilitres) sufficient for up to 28 days of supply per dispensing according to the patient&apos;s daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient&apos;s needs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Opioid dependence</p><br/><p>The treatment must be within a framework of medical, social and psychological treatment.</p> <p align=""justify"">The prescriber must request a quantity (in millilitres) sufficient for up to 28 days of supply per dispensing according to the patient&apos;s daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient&apos;s needs.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16016_5965_R","null","RESTRICTED","5965","16016","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes simplex keratitis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes simplex keratitis</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16017_16104_R","Initial treatment","STREAMLINED","16104","16017","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment-resistant migraine</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist; AND</p> <p>Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND</p> <p>Patient must have experienced at least 8 migraine headache days per month, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND</p> <p>Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND</p> <p>Patient must be appropriately managed by their practitioner for medication overuse headache, prior to initiation of treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.</p> <p align=""justify"">Patient must have the number of migraine headache days per month documented in their medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment-resistant migraine</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist; AND</p> <p>Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND</p> <p>Patient must have experienced at least 8 migraine headache days per month, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND</p> <p>Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND</p> <p>Patient must be appropriately managed by their practitioner for medication overuse headache, prior to initiation of treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.</p> <p align=""justify"">Patient must have the number of migraine headache days per month documented in their medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16019_7927_R","null","STREAMLINED","7927","16019","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute mania</p><br/><p>The condition must be associated with bipolar I disorder; AND</p> <p>The treatment must be as monotherapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute mania</p><br/><p>The condition must be associated with bipolar I disorder; AND</p> <p>The treatment must be as monotherapy.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16020_16022_R","Continuing treatment - First-line therapy","AUTHORITY_REQUIRED","16022","16020","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Continuing treatment - First-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition as first-line therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND</p> <p>Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Continuing treatment - First-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition as first-line therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND</p> <p>Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16025_14300_R","Continuing treatment","STREAMLINED","14300","16025","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of recurrent venous thromboembolism</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have a history of venous thromboembolism.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of recurrent venous thromboembolism</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have a history of venous thromboembolism.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16026_16123_R","null","STREAMLINED","16123","16026","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk of unstable angina</p><br/><p>Patient must have new transient or persistent ST-T ischaemic changes; AND</p> <p>Patient must have pain lasting longer than 20 minutes; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk of unstable angina</p><br/><p>Patient must have new transient or persistent ST-T ischaemic changes; AND</p> <p>Patient must have pain lasting longer than 20 minutes; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16027_6210_R","null","RESTRICTED","6210","16027","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Keloid</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Keloid</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16028_6281_R","null","RESTRICTED","6281","16028","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Lichen planus hypertrophic</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Lichen planus hypertrophic</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16031_15965_R","null","RESTRICTED","15965","16031","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious supra-ventricular cardiac arrhythmias</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious supra-ventricular cardiac arrhythmias</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16032_16141_R","null","STREAMLINED","16141","16032","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cryptococcal meningitis</p><br/><p>Patient must be unable to take a solid dose form of fluconazole; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cryptococcal meningitis</p><br/><p>Patient must be unable to take a solid dose form of fluconazole; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16033_15973_R","null","AUTHORITY_REQUIRED","15973","16033","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Leprosy</p><br/><p>Patient must be an adult; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Leprosy</p><br/><p>Patient must be an adult; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16036_16099_R","Treatment and maintenance therapy","STREAMLINED","16099","16036","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Disseminated pulmonary histoplasmosis infection</p><br/><p>Treatment and maintenance therapy</p><br/><p>Patient must be diagnosed with acquired immunodeficiency syndrome (AIDS); AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Disseminated pulmonary histoplasmosis infection</p><br/><p>Treatment and maintenance therapy</p><br/><p>Patient must be diagnosed with acquired immunodeficiency syndrome (AIDS); AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16038_16075_R","null","RESTRICTED","16075","16038","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Meningococcal disease</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be a carrier of the disease; or</p> <p>Patient must be in close contact with people who have the disease; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Meningococcal disease</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be a carrier of the disease; or</p> <p>Patient must be in close contact with people who have the disease; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16039_16094_R","Treatment and maintenance therapy","AUTHORITY_REQUIRED","16094","16039","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious fungal infections</p><br/><p>Treatment and maintenance therapy</p><br/><p>The condition must be caused by Scedosporium species; or</p> <p>The condition must be caused by Fusarium species; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious fungal infections</p><br/><p>Treatment and maintenance therapy</p><br/><p>The condition must be caused by Scedosporium species; or</p> <p>The condition must be caused by Fusarium species; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16040_16043_R","null","AUTHORITY_REQUIRED","16043","16040","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycobacterium ulcerans infection (Buruli ulcer)</p><br/><p>The treatment must be used in combination with another antibiotic for the treatment of Buruli ulcer; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycobacterium ulcerans infection (Buruli ulcer)</p><br/><p>The treatment must be used in combination with another antibiotic for the treatment of Buruli ulcer; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16041_16042_R","Treatment and maintenance therapy","AUTHORITY_REQUIRED","16042","16041","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Definite or probable invasive aspergillosis</p><br/><p>Treatment and maintenance therapy</p><br/><p>Patient must be immunocompromised; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Definite or probable invasive aspergillosis</p><br/><p>Treatment and maintenance therapy</p><br/><p>Patient must be immunocompromised; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16044_15986_R","Continuing/maintenance treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene","AUTHORITY_REQUIRED","15986","16044","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must not be undergoing treatment through this ''Continuing treatment'' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must have been 18 years of age or younger at the time of initial treatment with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.</p> <p align=""justify"">The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant &apos;Note&apos; attached to this listing.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must not be undergoing treatment through this ''Continuing treatment'' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must have been 18 years of age or younger at the time of initial treatment with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.</p> <p align=""justify"">The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant &apos;Note&apos; attached to this listing.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16046_16078_R","null","RESTRICTED","16078","16046","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16047_5912_R","null","STREAMLINED","5912","16047","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bipolar I disorder</p><br/><p>The condition must be refractory to treatment; AND</p> <p>The treatment must be in combination with lithium or sodium valproate; AND</p> <p>The treatment must be maintenance therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bipolar I disorder</p><br/><p>The condition must be refractory to treatment; AND</p> <p>The treatment must be in combination with lithium or sodium valproate; AND</p> <p>The treatment must be maintenance therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16049_5742_R","null","STREAMLINED","5742","16049","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute mania or mixed episodes</p><br/><p>The condition must be associated with bipolar I disorder; AND</p> <p>The treatment must be as monotherapy; AND</p> <p>The treatment must be limited to up to 6 months per episode.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute mania or mixed episodes</p><br/><p>The condition must be associated with bipolar I disorder; AND</p> <p>The treatment must be as monotherapy; AND</p> <p>The treatment must be limited to up to 6 months per episode.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16052_5981_R","null","RESTRICTED","5981","16052","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Confirmed or suspected Plasmodium falciparum malaria</p><br/><p>Patient must be aged 3 years or older; AND</p> <p>The treatment must be used where quinine containing regimens are inappropriate.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Confirmed or suspected Plasmodium falciparum malaria</p><br/><p>Patient must be aged 3 years or older; AND</p> <p>The treatment must be used where quinine containing regimens are inappropriate.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16054_16054_R","Continuing treatment","AUTHORITY_REQUIRED","16054","16054","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycosis fungoides cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be treated by at least one of the following prescriber types (i) dermatologist, (ii) haematologist; AND</p> <p>The treatment must be approved for 1 unit if the condition is no more than 10% of the patient''s body surface area to provide 4 weeks of treatment per script; or</p> <p>The treatment must be approved for 2 units if the condition is no more than 25% of the patient''s body surface area to provide 4 weeks of treatment per script.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycosis fungoides cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be treated by at least one of the following prescriber types (i) dermatologist, (ii) haematologist; AND</p> <p>The treatment must be approved for 1 unit if the condition is no more than 10% of the patient''s body surface area to provide 4 weeks of treatment per script; or</p> <p>The treatment must be approved for 2 units if the condition is no more than 25% of the patient''s body surface area to provide 4 weeks of treatment per script.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16055_16055_R","Continuing treatment","STREAMLINED","16055","16055","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be active; AND</p> <p>Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND</p> <p>The treatment must be after failure of other therapy including dopamine agonists; or</p> <p>The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or</p> <p>The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised pegvisomant.</p> <p align=""justify"">In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be active; AND</p> <p>Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND</p> <p>The treatment must be after failure of other therapy including dopamine agonists; or</p> <p>The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or</p> <p>The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised pegvisomant.</p> <p align=""justify"">In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. </p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16058_4098_R","Initial treatment","STREAMLINED","4098","16058","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Deep vein thrombosis</p><br/><p>Initial treatment</p><br/><p>Patient must have confirmed acute symptomatic deep vein thrombosis; AND</p> <p>Patient must not have symptomatic pulmonary embolism.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Deep vein thrombosis</p><br/><p>Initial treatment</p><br/><p>Patient must have confirmed acute symptomatic deep vein thrombosis; AND</p> <p>Patient must not have symptomatic pulmonary embolism.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16059_10992_R","Continuing treatment","STREAMLINED","10992","16059","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic stable atherosclerotic disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with aspirin, but not with any other anti-platelet therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic stable atherosclerotic disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with aspirin, but not with any other anti-platelet therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16060_4381_R","null","STREAMLINED","4381","16060","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total knee replacement; AND</p> <p>Patient must require up to 10 days of therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total knee replacement; AND</p> <p>Patient must require up to 10 days of therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16061_14318_R","Continuing treatment","STREAMLINED","14318","16061","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary embolism</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have confirmed acute symptomatic pulmonary embolism.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary embolism</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have confirmed acute symptomatic pulmonary embolism.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16062_16147_R","null","STREAMLINED","16147","16062","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk of unstable angina</p><br/><p>Patient must have new transient or persistent ST-T ischaemic changes; AND</p> <p>Patient must have repetitive episodes of angina at rest or during minimal exercise in the previous 12 hours; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk of unstable angina</p><br/><p>Patient must have new transient or persistent ST-T ischaemic changes; AND</p> <p>Patient must have repetitive episodes of angina at rest or during minimal exercise in the previous 12 hours; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16064_14264_R","Continuing treatment","STREAMLINED","14264","16064","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Deep vein thrombosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have confirmed acute symptomatic deep vein thrombosis; AND</p> <p>Patient must not have symptomatic pulmonary embolism.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Deep vein thrombosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have confirmed acute symptomatic deep vein thrombosis; AND</p> <p>Patient must not have symptomatic pulmonary embolism.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16065_6211_R","null","RESTRICTED","6211","16065","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic discoid lupus erythematosus</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic discoid lupus erythematosus</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16066_6253_R","null","RESTRICTED","6253","16066","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Alopecia areata</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Alopecia areata</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16068_15966_R","null","RESTRICTED","15966","16068","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious ventricular cardiac arrhythmias</p><br/><p>The treatment must be initiated in a hospital; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious ventricular cardiac arrhythmias</p><br/><p>The treatment must be initiated in a hospital; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16069_16148_R","null","STREAMLINED","16148","16069","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cryptococcal meningitis</p><br/><p>The treatment must be maintenance therapy; AND</p> <p>Patient must be immunosuppressed; AND</p> <p>Patient must be unable to take a solid dose form of fluconazole; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cryptococcal meningitis</p><br/><p>The treatment must be maintenance therapy; AND</p> <p>Patient must be immunosuppressed; AND</p> <p>Patient must be unable to take a solid dose form of fluconazole; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16070_6046_R","null","STREAMLINED","6046","16070","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oesophageal candidiasis</p><br/><p>Patient must be immunosuppressed; AND</p> <p>Patient must be unable to take a solid dose form of fluconazole.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oesophageal candidiasis</p><br/><p>Patient must be immunosuppressed; AND</p> <p>Patient must be unable to take a solid dose form of fluconazole.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16071_16034_R","null","STREAMLINED","16034","16071","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fungal infection</p><br/><p>The condition must be serious or life-threatening; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fungal infection</p><br/><p>The condition must be serious or life-threatening; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16074_16037_R","null","RESTRICTED","16037","16074","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Haemophilus influenzae type B</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be in contact with people who have the disease; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Haemophilus influenzae type B</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be in contact with people who have the disease; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16076_15984_R","null","STREAMLINED","15984","16076","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cryptococcal meningitis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cryptococcal meningitis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16077_5729_R","null","STREAMLINED","5729","16077","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (stage D) carcinoma of the prostate</p><br/><p>The treatment must be in combination with GnRH (LH-RH) analogue therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (stage D) carcinoma of the prostate</p><br/><p>The treatment must be in combination with GnRH (LH-RH) analogue therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16079_14313_R","null","STREAMLINED","14313","16079","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic gout</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be either chronic gouty arthritis or chronic tophaceous gout; AND</p> <p>Patient must have a medical contraindication to allopurinol; or</p> <p>Patient must have a documented history of allopurinol hypersensitivity syndrome; or</p> <p>Patient must have an intolerance to allopurinol necessitating permanent treatment discontinuation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic gout</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be either chronic gouty arthritis or chronic tophaceous gout; AND</p> <p>Patient must have a medical contraindication to allopurinol; or</p> <p>Patient must have a documented history of allopurinol hypersensitivity syndrome; or</p> <p>Patient must have an intolerance to allopurinol necessitating permanent treatment discontinuation.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16080_4941_R","Continuing treatment","AUTHORITY_REQUIRED","4941","16080","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Continuing treatment</p><br/><p>Patient must be receiving palliative care; AND</p> <p>The condition must be unresponsive to non-opioid analgesics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Continuing treatment</p><br/><p>Patient must be receiving palliative care; AND</p> <p>The condition must be unresponsive to non-opioid analgesics.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16081_9248_R","null","RESTRICTED","9248","16081","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Breathlessness</p><br/><p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Breathlessness</p><br/><p>Patient must be receiving palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16082_16051_R","null","STREAMLINED","16051","16082","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Opioid dependence</p><br/><p>Must be treated by a health care professional; AND</p> <p>The treatment must be within a framework of medical, social and psychological treatment.</p> <p align=""justify"">The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient&apos;s needs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Opioid dependence</p><br/><p>Must be treated by a health care professional; AND</p> <p>The treatment must be within a framework of medical, social and psychological treatment.</p> <p align=""justify"">The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient&apos;s needs.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16084_16053_R","Initial treatment","STREAMLINED","16053","16084","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) Merkel Cell Carcinoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a total of 9 doses at a maximum dose of 10 mg per kg every 2 weeks under this restriction; or</p> <p>The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.</p> <p align=""justify"">The patient&apos;s body weight must be documented in the patient&apos;s medical records at the time treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) Merkel Cell Carcinoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a total of 9 doses at a maximum dose of 10 mg per kg every 2 weeks under this restriction; or</p> <p>The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.</p> <p align=""justify"">The patient&apos;s body weight must be documented in the patient&apos;s medical records at the time treatment is initiated.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16086_6168_R","null","AUTHORITY_REQUIRED","6168","16086","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disabling pain</p><br/><p>Patient must be receiving palliative care; AND</p> <p>The condition must be unresponsive to non-opioid analgesics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disabling pain</p><br/><p>Patient must be receiving palliative care; AND</p> <p>The condition must be unresponsive to non-opioid analgesics.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16088_16057_R","Initial treatment","STREAMLINED","16057","16088","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting; AND</p> <p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months'' therapy at a dose of 120 mg every 28 days.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting; AND</p> <p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months'' therapy at a dose of 120 mg every 28 days.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16089_5746_R","null","STREAMLINED","5746","16089","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute coronary syndrome (myocardial infarction or unstable angina)</p><br/><p>The treatment must be in combination with aspirin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute coronary syndrome (myocardial infarction or unstable angina)</p><br/><p>The treatment must be in combination with aspirin.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16091_4402_R","null","STREAMLINED","4402","16091","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total hip replacement; AND</p> <p>Patient must require up to 30 days supply to complete a course of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total hip replacement; AND</p> <p>Patient must require up to 30 days supply to complete a course of treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16092_16063_R","null","STREAMLINED","16063","16092","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-Q-wave myocardial infarction</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-Q-wave myocardial infarction</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16093_6268_R","null","RESTRICTED","6268","16093","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Local intra-articular or peri-articular infiltration</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Local intra-articular or peri-articular infiltration</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16095_16117_R","null","AUTHORITY_REQUIRED","16117","16095","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prophylaxis of invasive fungal infections including both yeasts and moulds</p><br/><p>Patient must be considered at high risk of developing an invasive fungal infection due to anticipated neutropenia (an absolute neutrophil count less than 500 cells per cubic millimetre), for at least 10 days whilst receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome; or</p> <p>Patient must be considered at high risk of developing an invasive fungal infection due to having acute graft versus host disease (GVHD) grade II, III or IV, or extensive chronic GVHD, and receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p> <p align=""justify"">Treatment of neutropenia should continue until recovery of the neutrophil count to at least 500 cells per cubic millimetre.</p> <p align=""justify"">Patients who have had a previous invasive fungal infection should have secondary prophylaxis during subsequent episodes of neutropenia.</p> <p align=""justify"">No more than 6 months therapy per episode will be PBS-subsidised</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prophylaxis of invasive fungal infections including both yeasts and moulds</p><br/><p>Patient must be considered at high risk of developing an invasive fungal infection due to anticipated neutropenia (an absolute neutrophil count less than 500 cells per cubic millimetre), for at least 10 days whilst receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome; or</p> <p>Patient must be considered at high risk of developing an invasive fungal infection due to having acute graft versus host disease (GVHD) grade II, III or IV, or extensive chronic GVHD, and receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p> <p align=""justify"">Treatment of neutropenia should continue until recovery of the neutrophil count to at least 500 cells per cubic millimetre.</p> <p align=""justify"">Patients who have had a previous invasive fungal infection should have secondary prophylaxis during subsequent episodes of neutropenia.</p> <p align=""justify"">No more than 6 months therapy per episode will be PBS-subsidised</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16097_15978_R","null","STREAMLINED","15978","16097","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic sporotrichosis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic sporotrichosis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16098_16035_R","null","STREAMLINED","16035","16098","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic histoplasmosis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic histoplasmosis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16100_16101_R","Treatment and maintenance therapy","STREAMLINED","16101","16100","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic pulmonary histoplasmosis infection</p><br/><p>Treatment and maintenance therapy</p><br/><p>Patient must be diagnosed with acquired immunodeficiency syndrome (AIDS); AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic pulmonary histoplasmosis infection</p><br/><p>Treatment and maintenance therapy</p><br/><p>Patient must be diagnosed with acquired immunodeficiency syndrome (AIDS); AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16103_6030_R","null","STREAMLINED","6030","16103","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oropharyngeal candidiasis</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be immunosuppressed.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oropharyngeal candidiasis</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be immunosuppressed.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16105_16018_R","Initial treatment","STREAMLINED","16018","16105","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic migraine</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist; AND</p> <p>Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND</p> <p>Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND</p> <p>Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND</p> <p>Patient must be appropriately managed by their practitioner for medication overuse headache, prior to initiation of treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.</p> <p align=""justify"">Patient must have the number of migraine days per month documented in their medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic migraine</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist; AND</p> <p>Patient must not be undergoing concurrent treatment with the following PBS benefits: (i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND</p> <p>Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND</p> <p>Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND</p> <p>Patient must be appropriately managed by their practitioner for medication overuse headache, prior to initiation of treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.</p> <p align=""justify"">Patient must have the number of migraine days per month documented in their medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16106_16023_R","Continuing treatment - Second-line therapy","AUTHORITY_REQUIRED","16023","16106","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Continuing treatment - Second-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy; AND</p> <p>The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND</p> <p>Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Continuing treatment - Second-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy; AND</p> <p>The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND</p> <p>Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16108_4132_R","Continuing treatment","STREAMLINED","4132","16108","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of recurrent venous thromboembolism</p><br/><p>Continuing treatment</p><br/><p>Patient must have a history of venous thromboembolism.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of recurrent venous thromboembolism</p><br/><p>Continuing treatment</p><br/><p>Patient must have a history of venous thromboembolism.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16109_5098_R","Initial treatment","STREAMLINED","5098","16109","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary embolism</p><br/><p>Initial treatment</p><br/><p>Patient must have confirmed acute symptomatic pulmonary embolism.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary embolism</p><br/><p>Initial treatment</p><br/><p>Patient must have confirmed acute symptomatic pulmonary embolism.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16110_4382_R","null","STREAMLINED","4382","16110","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total knee replacement; AND</p> <p>Patient must require up to 15 days of therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total knee replacement; AND</p> <p>Patient must require up to 15 days of therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16112_6269_R","null","RESTRICTED","6269","16112","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Necrobiosis lipoidica</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Necrobiosis lipoidica</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16113_6212_R","null","RESTRICTED","6212","16113","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uveitis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uveitis</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16116_15981_R","Treatment and maintenance therapy","AUTHORITY_REQUIRED","15981","16116","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious invasive mycosis infections</p><br/><p>Treatment and maintenance therapy</p><br/><p>The treatment must be for invasive mycosis infections other than definite or probable invasive aspergillosis; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious invasive mycosis infections</p><br/><p>Treatment and maintenance therapy</p><br/><p>The treatment must be for invasive mycosis infections other than definite or probable invasive aspergillosis; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16118_16119_R","null","STREAMLINED","16119","16118","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic aspergillosis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic aspergillosis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16120_5609_R","null","STREAMLINED","5609","16120","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate Pneumocystis carinii pneumonia</p><br/><p>Patient must be an adult; AND</p> <p>Patient must be intolerant of trimethoprim/sulfamethoxazole therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate Pneumocystis carinii pneumonia</p><br/><p>Patient must be an adult; AND</p> <p>Patient must be intolerant of trimethoprim/sulfamethoxazole therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16122_14298_R","Continuing treatment","STREAMLINED","14298","16122","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic stable atherosclerotic disease</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with aspirin, but not with any other anti-platelet therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic stable atherosclerotic disease</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with aspirin, but not with any other anti-platelet therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16124_4409_R","null","STREAMLINED","4409","16124","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total hip replacement; AND</p> <p>Patient must require up to 15 days supply to complete a course of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total hip replacement; AND</p> <p>Patient must require up to 15 days supply to complete a course of treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16125_15967_R","null","RESTRICTED","15967","16125","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cardiac arrhythmias</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cardiac arrhythmias</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16127_6031_R","null","STREAMLINED","6031","16127","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oropharyngeal candidiasis</p><br/><p>Patient must be immunosuppressed; AND</p> <p>Patient must be unable to take a solid dose form of fluconazole.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oropharyngeal candidiasis</p><br/><p>Patient must be immunosuppressed; AND</p> <p>Patient must be unable to take a solid dose form of fluconazole.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16128_4902_R","Initial treatment, for up to 3 months","AUTHORITY_REQUIRED","4902","16128","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial treatment, for up to 3 months</p><br/><p>Patient must be receiving palliative care; AND</p> <p>The condition must be unresponsive to non-opioid analgesics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>Initial treatment, for up to 3 months</p><br/><p>Patient must be receiving palliative care; AND</p> <p>The condition must be unresponsive to non-opioid analgesics.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16129_10386_R","Maintenance therapy","STREAMLINED","10386","16129","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>Patient must have been commenced on treatment in a hospital-based movement disorder clinic; AND</p> <p>Patient must require continuous administration of levodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2000 mg of levodopa.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>Patient must have been commenced on treatment in a hospital-based movement disorder clinic; AND</p> <p>Patient must require continuous administration of levodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2000 mg of levodopa.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16130_5719_R","null","STREAMLINED","5719","16130","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bipolar I disorder</p><br/><p>The treatment must be maintenance therapy; AND</p> <p>The treatment must be as monotherapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bipolar I disorder</p><br/><p>The treatment must be maintenance therapy; AND</p> <p>The treatment must be as monotherapy.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16131_16085_R","Continuing treatment","STREAMLINED","16085","16131","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) Merkel Cell Carcinoma</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 10 mg per kg every 2 weeks under this restriction; or</p> <p>The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) Merkel Cell Carcinoma</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 10 mg per kg every 2 weeks under this restriction; or</p> <p>The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16134_4099_R","Continuing treatment","STREAMLINED","4099","16134","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Deep vein thrombosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have confirmed acute symptomatic deep vein thrombosis; AND</p> <p>Patient must not have symptomatic pulmonary embolism.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Deep vein thrombosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have confirmed acute symptomatic deep vein thrombosis; AND</p> <p>Patient must not have symptomatic pulmonary embolism.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16135_4268_R","Continuing treatment","STREAMLINED","4268","16135","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary embolism</p><br/><p>Continuing treatment</p><br/><p>Patient must have confirmed acute symptomatic pulmonary embolism.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary embolism</p><br/><p>Continuing treatment</p><br/><p>Patient must have confirmed acute symptomatic pulmonary embolism.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16136_4369_R","null","STREAMLINED","4369","16136","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total hip replacement; AND</p> <p>Patient must require up to 20 days supply to complete a course of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total hip replacement; AND</p> <p>Patient must require up to 20 days supply to complete a course of treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16137_4359_R","null","STREAMLINED","4359","16137","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total hip replacement; AND</p> <p>Patient must require up to 10 days supply to complete a course of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of venous thromboembolism</p><br/><p>Patient must be undergoing total hip replacement; AND</p> <p>Patient must require up to 10 days supply to complete a course of treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16138_6255_R","null","RESTRICTED","6255","16138","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Lichen simplex chronicus</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Lichen simplex chronicus</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16139_6287_R","null","RESTRICTED","6287","16139","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Psoriasis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Psoriasis</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16140_6032_R","null","STREAMLINED","6032","16140","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oropharyngeal candidiasis</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be immunosuppressed; AND</p> <p>Patient must be unable to take a solid dose form of fluconazole.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Oropharyngeal candidiasis</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be immunosuppressed; AND</p> <p>Patient must be unable to take a solid dose form of fluconazole.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16142_16072_R","null","AUTHORITY_REQUIRED","16072","16142","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Invasive aspergillosis</p><br/><p>Patient must be unable to tolerate alternative therapy; or</p> <p>Patient must have disease refractory to alternative therapy; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Invasive aspergillosis</p><br/><p>Patient must be unable to tolerate alternative therapy; or</p> <p>Patient must have disease refractory to alternative therapy; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16143_16096_R","null","AUTHORITY_REQUIRED","16096","16143","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fungal infection</p><br/><p>The condition must be fusariosis; or</p> <p>The condition must be zygomycosis; or</p> <p>The condition must be coccidioidomycosis; or</p> <p>The condition must be chromoblastomycosis; or</p> <p>The condition must be mycetoma; AND</p> <p>Patient must be unable to tolerate alternative therapy; or</p> <p>Patient must have disease refractory to alternative therapy; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fungal infection</p><br/><p>The condition must be fusariosis; or</p> <p>The condition must be zygomycosis; or</p> <p>The condition must be coccidioidomycosis; or</p> <p>The condition must be chromoblastomycosis; or</p> <p>The condition must be mycetoma; AND</p> <p>Patient must be unable to tolerate alternative therapy; or</p> <p>Patient must have disease refractory to alternative therapy; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16145_16145_R","Initial treatment","AUTHORITY_REQUIRED","16145","16145","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycosis fungoides cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>The condition must be any of: (i) Stage IA, (ii) IIA, (iii) IB mycosis fungoides cutaneous T-cell lymphoma; AND</p> <p>The condition must have been confirmed through a diagnostic lesion biopsy from an Approved Pathology Authority; AND</p> <p>The condition must cover either of which: (i) no more than 10% of the patient''s body surface area, (ii) no more than 25% of the patient''s body surface area; AND</p> <p>Patient must be treated by at least one of the following prescriber types (i) dermatologist, (ii) haematologist; AND</p> <p>The treatment must be approved for 1 unit if the condition is no more than 10% of the patient''s body surface area to provide 4 weeks of treatment per script; or</p> <p>The treatment must be approved for 2 units if the condition is no more than 25% of the patient''s body surface area to provide 4 weeks of treatment per script; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycosis fungoides cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>The condition must be any of: (i) Stage IA, (ii) IIA, (iii) IB mycosis fungoides cutaneous T-cell lymphoma; AND</p> <p>The condition must have been confirmed through a diagnostic lesion biopsy from an Approved Pathology Authority; AND</p> <p>The condition must cover either of which: (i) no more than 10% of the patient''s body surface area, (ii) no more than 25% of the patient''s body surface area; AND</p> <p>Patient must be treated by at least one of the following prescriber types (i) dermatologist, (ii) haematologist; AND</p> <p>The treatment must be approved for 1 unit if the condition is no more than 10% of the patient''s body surface area to provide 4 weeks of treatment per script; or</p> <p>The treatment must be approved for 2 units if the condition is no more than 25% of the patient''s body surface area to provide 4 weeks of treatment per script; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16150_10197_R","Maintenance therapy","STREAMLINED","10197","16150","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>Patient must have been commenced on treatment in a hospital-based movement disorder clinic.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>Patient must have been commenced on treatment in a hospital-based movement disorder clinic.</p>","N","N","N","IMMEDIATE","ALL","N","2024-11-01","N","4708"
"16157_16220_R","null","STREAMLINED","16220","16157","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The treatment must be in combination with metformin; unless contraindicated/intolerant; AND</p> <p>Patient must have cardiovascular disease; or</p> <p>Patient must be at high risk of a cardiovascular event; or</p> <p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The treatment must be in combination with metformin; unless contraindicated/intolerant; AND</p> <p>Patient must have cardiovascular disease; or</p> <p>Patient must be at high risk of a cardiovascular event; or</p> <p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor.</p> <p align=""justify"">The Australian Absolute Cardiovascular Disease Risk Calculator is available at www.cvdcheck.org.au.</p><p align=""justify"">High cardiovascular risk is defined as an estimated risk of a cardiovascular event of at least 10% over 5 years.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16159_16158_R","null","STREAMLINED","16158","16159","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>Patient must have cardiovascular disease; or</p> <p>Patient must be at high risk of a cardiovascular event; or</p> <p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>Patient must have cardiovascular disease; or</p> <p>Patient must be at high risk of a cardiovascular event; or</p> <p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor.</p> <p align=""justify"">The Australian Absolute Cardiovascular Disease Risk Calculator is available at www.cvdcheck.org.au.</p><p align=""justify"">High cardiovascular risk is defined as an estimated risk of a cardiovascular event of at least 10% over 5 years.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16160_16162_R","null","STREAMLINED","16162","16160","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have cardiovascular disease; or</p> <p>Patient must be at high risk of a cardiovascular event; or</p> <p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have cardiovascular disease; or</p> <p>Patient must be at high risk of a cardiovascular event; or</p> <p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor.</p> <p align=""justify"">The Australian Absolute Cardiovascular Disease Risk Calculator is available at www.cvdcheck.org.au.</p><p align=""justify"">High cardiovascular risk is defined as an estimated risk of a cardiovascular event of at least 10% over 5 years.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16161_15267_R","null","STREAMLINED","15267","16161","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately responsive to metformin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately responsive to metformin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor.</p> <p align=""justify"">Definition:</p><p align=""justify"">A HbA1c measurement greater than 7% despite treatment with the specified prior therapy/therapies indicates inadequate responsiveness. Where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2-week period indicates inadequate responsiveness.</p><p align=""justify"">Blood glucose monitoring is an alternative to HbA1c measurement where at least one of the following circumstances applies:</p><p align=""justify"">(a) A clinical condition with reduced red blood cell survival (inclusive of haemolytic anaemias, haemoglobinopathies),</p><p align=""justify"">(b) Red cell transfusion within the previous 3 months.</p><p align=""justify"">Document HbA1c measurements (blood glucose measurements where relevant), as well as any intolerances/contraindications in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16163_16164_R","null","STREAMLINED","16164","16163","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be in combination with metformin; unless contraindicated/intolerant; AND</p> <p>Patient must have cardiovascular disease; or</p> <p>Patient must be at high risk of a cardiovascular event; or</p> <p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be in combination with metformin; unless contraindicated/intolerant; AND</p> <p>Patient must have cardiovascular disease; or</p> <p>Patient must be at high risk of a cardiovascular event; or</p> <p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment for this condition with any of: (i) a GLP-1 receptor agonist, (ii) another SGLT2 inhibitor.</p> <p align=""justify"">The Australian Absolute Cardiovascular Disease Risk Calculator is available at www.cvdcheck.org.au.</p><p align=""justify"">High cardiovascular risk is defined as an estimated risk of a cardiovascular event of at least 10% over 5 years.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16165_16166_R","null","AUTHORITY_REQUIRED","16166","16165","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>Patient must have an established pituitary or testicular disorder; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>Patient must have an established pituitary or testicular disorder; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16167_16214_R","null","AUTHORITY_REQUIRED","16214","16167","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must not have an established pituitary or testicular disorder; AND</p> <p>The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs; AND</p> <p>Patient must be aged 40 years or older; AND</p> <p>Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">Androgen deficiency is defined as:</p><p align=""justify"">(i) testosterone level of less than 6 nmol per litre; OR</p><p align=""justify"">(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).</p><p align=""justify"">Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.</p> <p>The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must not have an established pituitary or testicular disorder; AND</p> <p>The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs; AND</p> <p>Patient must be aged 40 years or older; AND</p> <p>Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">Androgen deficiency is defined as:</p><p align=""justify"">(i) testosterone level of less than 6 nmol per litre; OR</p><p align=""justify"">(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).</p><p align=""justify"">Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.</p> <p>The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16168_16197_R","Consolidation therapy","AUTHORITY_REQUIRED","16197","16168","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Consolidation therapy</p><br/><p>The treatment must be for consolidation treatment following induction treatment with this product; AND</p> <p>The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND</p> <p>The treatment must not exceed two cycles of consolidation therapy under this restriction.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""left"">The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.</p><p align=""left"">Each prescription must include the amount of daunorubicin with cytarabine (Vyxeos) that is appropriate to be prescribed for the patient. For the purposes of the authority application, the maximum amount requested is based on the daunorubicin dose only. The prescribed amount of daunorubicin must be expressed in milligrams.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Consolidation therapy</p><br/><p>The treatment must be for consolidation treatment following induction treatment with this product; AND</p> <p>The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND</p> <p>The treatment must not exceed two cycles of consolidation therapy under this restriction.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""left"">The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.</p><p align=""left"">Each prescription must include the amount of daunorubicin with cytarabine (Vyxeos) that is appropriate to be prescribed for the patient. For the purposes of the authority application, the maximum amount requested is based on the daunorubicin dose only. The prescribed amount of daunorubicin must be expressed in milligrams.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16169_16169_R","Balance of Supply - Initial 1 treatment (new patient) and Initial 2 treatment (recommencement of treatment after a break in biological medicine)","AUTHORITY_REQUIRED","16169","16169","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe chronic pouchitis</p><br/><p>Balance of Supply - Initial 1 treatment (new patient) and Initial 2 treatment (recommencement of treatment after a break in biological medicine)</p><br/><p>Patient must have received insufficient therapy with this drug under the Initial 1 treatment (new patient) restriction to complete 14 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 2 treatment (recommencement of treatment after a break in biological medicine) to complete 14 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks treatment available under the above treatment phases; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe chronic pouchitis</p><br/><p>Balance of Supply - Initial 1 treatment (new patient) and Initial 2 treatment (recommencement of treatment after a break in biological medicine)</p><br/><p>Patient must have received insufficient therapy with this drug under the Initial 1 treatment (new patient) restriction to complete 14 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 2 treatment (recommencement of treatment after a break in biological medicine) to complete 14 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks treatment available under the above treatment phases; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16174_16223_R","null","STREAMLINED","16223","16174","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must have at least one sign or symptom attributable to COVID-19; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>Patient must satisfy at least one of the following criteria: (i) be moderately to severely immunocompromised with risk of progression to severe COVID-19 disease due to the immunocompromised status, (ii) has experienced past COVID-19 infection resulting in hospitalisation; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">For the purpose of administering this restriction, &apos;moderately to severely immunocompromised&apos; patients are those with:</p><p align=""left"">1. Any primary or acquired immunodeficiency including:</p><p align=""left"">a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders,</p><p align=""left"">b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),</p><p align=""left"">c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR</p><p align=""left"">2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received:</p><p align=""left"">a. Chemotherapy or whole body radiotherapy,</p><p align=""left"">b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,</p><p align=""left"">c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin),</p><p align=""left"">d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR</p><p align=""left"">3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR</p><p align=""left"">4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR</p><p align=""left"">5. People with disability with multiple comorbidities and/or frailty.</p><p align=""left"">Details of the patient&apos;s medical condition necessitating use of this drug must be recorded in the patient&apos;s medical records</p> <p align=""justify"">For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must have at least one sign or symptom attributable to COVID-19; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>Patient must satisfy at least one of the following criteria: (i) be moderately to severely immunocompromised with risk of progression to severe COVID-19 disease due to the immunocompromised status, (ii) has experienced past COVID-19 infection resulting in hospitalisation; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">For the purpose of administering this restriction, &apos;moderately to severely immunocompromised&apos; patients are those with:</p><p align=""left"">1. Any primary or acquired immunodeficiency including:</p><p align=""left"">a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders,</p><p align=""left"">b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),</p><p align=""left"">c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR</p><p align=""left"">2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received:</p><p align=""left"">a. Chemotherapy or whole body radiotherapy,</p><p align=""left"">b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,</p><p align=""left"">c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin),</p><p align=""left"">d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR</p><p align=""left"">3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR</p><p align=""left"">4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR</p><p align=""left"">5. People with disability with multiple comorbidities and/or frailty.</p><p align=""left"">Details of the patient&apos;s medical condition necessitating use of this drug must be recorded in the patient&apos;s medical records</p> <p align=""justify"">For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16175_15265_R","null","STREAMLINED","15265","16175","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor.</p> <p align=""justify"">Definition:</p><p align=""justify"">A HbA1c measurement greater than 7% despite treatment with the specified prior therapy/therapies indicates inadequate responsiveness. Where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2-week period indicates inadequate responsiveness.</p><p align=""justify"">Blood glucose monitoring is an alternative to HbA1c measurement where at least one of the following circumstances applies:</p><p align=""justify"">(a) A clinical condition with reduced red blood cell survival (inclusive of haemolytic anaemias, haemoglobinopathies),</p><p align=""justify"">(b) Red cell transfusion within the previous 3 months.</p><p align=""justify"">Document HbA1c measurements (blood glucose measurements where relevant), as well as any intolerances/contraindications in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16176_16211_R","null","AUTHORITY_REQUIRED","16211","16176","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>Patient must not have an established pituitary or testicular disorder; AND</p> <p>The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs; AND</p> <p>Patient must be aged 40 years or older; AND</p> <p>Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">Androgen deficiency is defined as:</p><p align=""justify"">(i) testosterone level of less than 6 nmol per litre; OR</p><p align=""justify"">(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).</p><p align=""justify"">Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.</p> <p>The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>Patient must not have an established pituitary or testicular disorder; AND</p> <p>The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs; AND</p> <p>Patient must be aged 40 years or older; AND</p> <p>Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">Androgen deficiency is defined as:</p><p align=""justify"">(i) testosterone level of less than 6 nmol per litre; OR</p><p align=""justify"">(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).</p><p align=""justify"">Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.</p> <p>The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16177_16204_R","null","AUTHORITY_REQUIRED","16204","16177","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Micropenis</p><br/><p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Micropenis</p><br/><p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16178_16151_R","Continuing treatment","STREAMLINED","16151","16178","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen.</p> <p align=""left"">The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.</p><p align=""left"">The prescription must include the amount of nivolumab with relatlimab (Opdualag) that is appropriate to be prescribed for the patient. For the purposes of PBS subsidy, the maximum amount requested is based on the nivolumab dose only. The prescribed amount of nivolumab must be expressed in milligrams.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen.</p> <p align=""left"">The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.</p><p align=""left"">The prescription must include the amount of nivolumab with relatlimab (Opdualag) that is appropriate to be prescribed for the patient. For the purposes of PBS subsidy, the maximum amount requested is based on the nivolumab dose only. The prescribed amount of nivolumab must be expressed in milligrams.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16180_16180_R","Continuing treatment","AUTHORITY_REQUIRED","16180","16180","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Von Hippel-Lindau (VHL) disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same tumour type; AND</p> <p>Patient must not have developed VHL-associated metastatic disease; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of the condition while being treated with this drug, the details of which must be kept with the patient''s record; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for VHL disease associated tumours; AND</p> <p>Must be treated by a physician with expertise in the management of VHL disease associated tumours.</p> <p align=""justify"">Patients who cease therapy for reasons other than, clinical disease progression or metastasis, may re-initiate PBS-subsidised treatment through the initiating or recommencing treatment phase.</p> <p align=""justify"">For the purpose of administering this restriction, clinical improvement or stabilisation of the patient&apos;s condition includes but is not limited to:</p><p align=""justify"">(i) avoidance of surgery;</p><p align=""justify"">(ii) avoidance of renal replacement therapy such as dialysis or renal transplantation in patients with VHL- associated renal cell carcinoma (RCC);</p><p align=""justify"">(iii) experiencing clinical benefit in at least one of the VHL associated conditions, as determined by the treating clinician(s).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Von Hippel-Lindau (VHL) disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same tumour type; AND</p> <p>Patient must not have developed VHL-associated metastatic disease; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of the condition while being treated with this drug, the details of which must be kept with the patient''s record; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for VHL disease associated tumours; AND</p> <p>Must be treated by a physician with expertise in the management of VHL disease associated tumours.</p> <p align=""justify"">Patients who cease therapy for reasons other than, clinical disease progression or metastasis, may re-initiate PBS-subsidised treatment through the initiating or recommencing treatment phase.</p> <p align=""justify"">For the purpose of administering this restriction, clinical improvement or stabilisation of the patient&apos;s condition includes but is not limited to:</p><p align=""justify"">(i) avoidance of surgery;</p><p align=""justify"">(ii) avoidance of renal replacement therapy such as dialysis or renal transplantation in patients with VHL- associated renal cell carcinoma (RCC);</p><p align=""justify"">(iii) experiencing clinical benefit in at least one of the VHL associated conditions, as determined by the treating clinician(s).</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16181_16181_R","Continuing treatment","AUTHORITY_REQUIRED","16181","16181","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe chronic pouchitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received this drug as their most recent course of PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have demonstrated or sustained a partial or complete response, as determined by the treating clinician, to the most recent PBS-subsidised course of treatment with this drug for this condition; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">Patients who have failed to demonstrate a partial or complete response with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug for this condition</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">An application for the continuing treatment must be made following the third dose with this drug and requested no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where an application is not made within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe chronic pouchitis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received this drug as their most recent course of PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have demonstrated or sustained a partial or complete response, as determined by the treating clinician, to the most recent PBS-subsidised course of treatment with this drug for this condition; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">Patients who have failed to demonstrate a partial or complete response with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug for this condition</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">An application for the continuing treatment must be made following the third dose with this drug and requested no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where an application is not made within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16182_16200_R","null","STREAMLINED","16200","16182","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND</p> <p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must have at least one sign or symptom attributable to COVID-19; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; AND</p> <p>Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk.</p> <p align=""left"">For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions:</p><p align=""left"">1. The patient is in residential aged care</p><p align=""left"">2. The patient has disability with multiple comorbidities and/or frailty</p><p align=""left"">3. Neurological conditions, including stroke and dementia and demyelinating conditions</p><p align=""left"">4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease</p><p align=""left"">5. Heart failure, coronary artery disease, cardiomyopathies</p><p align=""left"">6. Obesity (BMI greater than 30 kg/m<sup>2</sup>)</p><p align=""left"">7. Diabetes type I or II, requiring medication for glycaemic control</p><p align=""left"">8. Renal impairment (eGFR less than 60mL/min)</p><p align=""left"">9. Cirrhosis</p><p align=""left"">10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above</p><p align=""left"">11. Past COVID-19 infection episode resulting in hospitalisation.</p><p align=""left"">Details of the patient&apos;s medical condition necessitating use of this drug must be recorded in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p> <p align=""justify"">For the purpose of administering this restriction, the contraindications to nirmatrelvir (&amp;) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.</p><p align=""justify"">Details/reasons of contraindications to nirmatrelvir (&amp;) ritonavir must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND</p> <p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must have at least one sign or symptom attributable to COVID-19; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; AND</p> <p>Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk.</p> <p align=""left"">For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions:</p><p align=""left"">1. The patient is in residential aged care</p><p align=""left"">2. The patient has disability with multiple comorbidities and/or frailty</p><p align=""left"">3. Neurological conditions, including stroke and dementia and demyelinating conditions</p><p align=""left"">4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease</p><p align=""left"">5. Heart failure, coronary artery disease, cardiomyopathies</p><p align=""left"">6. Obesity (BMI greater than 30 kg/m<sup>2</sup>)</p><p align=""left"">7. Diabetes type I or II, requiring medication for glycaemic control</p><p align=""left"">8. Renal impairment (eGFR less than 60mL/min)</p><p align=""left"">9. Cirrhosis</p><p align=""left"">10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above</p><p align=""left"">11. Past COVID-19 infection episode resulting in hospitalisation.</p><p align=""left"">Details of the patient&apos;s medical condition necessitating use of this drug must be recorded in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p> <p align=""justify"">For the purpose of administering this restriction, the contraindications to nirmatrelvir (&amp;) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.</p><p align=""justify"">Details/reasons of contraindications to nirmatrelvir (&amp;) ritonavir must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The Modified Monash Model categorises an area according to geographical remoteness and town size. Details can be found at: https://www.health.gov.au/health-topics/rural-health-workforce/classifications/mmm</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16183_16192_R","null","STREAMLINED","16192","16183","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must have at least one sign or symptom attributable to COVID-19; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; AND</p> <p>Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk.</p> <p align=""left"">For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions:</p><p align=""left"">1. The patient is in residential aged care</p><p align=""left"">2. The patient has disability with multiple comorbidities and/or frailty</p><p align=""left"">3. Neurological conditions, including stroke and dementia and demyelinating conditions</p><p align=""left"">4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease</p><p align=""left"">5. Heart failure, coronary artery disease, cardiomyopathies</p><p align=""left"">6. Obesity (BMI greater than 30 kg/m<sup>2</sup>)</p><p align=""left"">7. Diabetes type I or II, requiring medication for glycaemic control</p><p align=""left"">8. Renal impairment (eGFR less than 60mL/min)</p><p align=""left"">9. Cirrhosis</p><p align=""left"">10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above</p><p align=""left"">11. Past COVID-19 infection episode resulting in hospitalisation.</p><p align=""left"">Details of the patient&apos;s medical condition necessitating use of this drug must be recorded in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must have at least one sign or symptom attributable to COVID-19; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; AND</p> <p>Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk.</p> <p align=""left"">For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions:</p><p align=""left"">1. The patient is in residential aged care</p><p align=""left"">2. The patient has disability with multiple comorbidities and/or frailty</p><p align=""left"">3. Neurological conditions, including stroke and dementia and demyelinating conditions</p><p align=""left"">4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease</p><p align=""left"">5. Heart failure, coronary artery disease, cardiomyopathies</p><p align=""left"">6. Obesity (BMI greater than 30 kg/m<sup>2</sup>)</p><p align=""left"">7. Diabetes type I or II, requiring medication for glycaemic control</p><p align=""left"">8. Renal impairment (eGFR less than 60mL/min)</p><p align=""left"">9. Cirrhosis</p><p align=""left"">10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above</p><p align=""left"">11. Past COVID-19 infection episode resulting in hospitalisation.</p><p align=""left"">Details of the patient&apos;s medical condition necessitating use of this drug must be recorded in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p> <p align=""justify"">The Modified Monash Model categorises an area according to geographical remoteness and town size. Details can be found at: https://www.health.gov.au/health-topics/rural-health-workforce/classifications/mmm</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16184_16207_R","null","AUTHORITY_REQUIRED","16207","16184","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pubertal induction</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pubertal induction</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16185_16195_R","null","AUTHORITY_REQUIRED","16195","16185","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constitutional delay of growth or puberty</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constitutional delay of growth or puberty</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16193_15289_R","null","STREAMLINED","15289","16193","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be inadequately responsive to metformin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be inadequately responsive to metformin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor.</p> <p align=""justify"">Definition:</p><p align=""justify"">A HbA1c measurement greater than 7% despite treatment with the specified prior therapy/therapies indicates inadequate responsiveness. Where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2-week period indicates inadequate responsiveness.</p><p align=""justify"">Blood glucose monitoring is an alternative to HbA1c measurement where at least one of the following circumstances applies:</p><p align=""justify"">(a) A clinical condition with reduced red blood cell survival (inclusive of haemolytic anaemias, haemoglobinopathies),</p><p align=""justify"">(b) Red cell transfusion within the previous 3 months.</p><p align=""justify"">Document HbA1c measurements (blood glucose measurements where relevant), as well as any intolerances/contraindications in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16196_16187_R","Induction therapy","AUTHORITY_REQUIRED","16187","16196","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Induction therapy</p><br/><p>Patient must not have received prior chemotherapy as induction therapy for this condition; AND</p> <p>The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND</p> <p>The condition must not be either: (i) internal tandem duplication (ITD); (ii) tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3), mutation positive; AND</p> <p>Patient must not have favourable cytogenetic risk acute myeloid leukaemia (AML); AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>The treatment must not exceed two cycles of induction therapy under this restriction.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">The prescriber must confirm whether the patient has newly diagnosed therapy-related AML or AML-MRC. The test result and date of testing must be provided at the time of application and documented in the patient&apos;s file.</p> <p align=""left"">The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.</p><p align=""left"">Each prescription must include the amount of daunorubicin with cytarabine (Vyxeos) that is appropriate to be prescribed for the patient. For the purposes of the authority application, the maximum amount requested is based on the daunorubicin dose only. The prescribed amount of daunorubicin must be expressed in milligrams.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Induction therapy</p><br/><p>Patient must not have received prior chemotherapy as induction therapy for this condition; AND</p> <p>The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND</p> <p>The condition must not be either: (i) internal tandem duplication (ITD); (ii) tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3), mutation positive; AND</p> <p>Patient must not have favourable cytogenetic risk acute myeloid leukaemia (AML); AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>The treatment must not exceed two cycles of induction therapy under this restriction.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">The prescriber must confirm whether the patient has newly diagnosed therapy-related AML or AML-MRC. The test result and date of testing must be provided at the time of application and documented in the patient&apos;s file.</p> <p align=""left"">The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.</p><p align=""left"">Each prescription must include the amount of daunorubicin with cytarabine (Vyxeos) that is appropriate to be prescribed for the patient. For the purposes of the authority application, the maximum amount requested is based on the daunorubicin dose only. The prescribed amount of daunorubicin must be expressed in milligrams.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16198_16191_R","null","STREAMLINED","16191","16198","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND</p> <p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must have at least one sign or symptom attributable to COVID-19; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>Patient must satisfy at least one of the following criteria: (i) be moderately to severely immunocompromised with risk of progression to severe COVID-19 disease due to the immunocompromised status, (ii) has experienced past COVID-19 infection resulting in hospitalisation; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">For the purpose of administering this restriction, &apos;moderately to severely immunocompromised&apos; patients are those with:</p><p align=""left"">1. Any primary or acquired immunodeficiency including:</p><p align=""left"">a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders,</p><p align=""left"">b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),</p><p align=""left"">c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR</p><p align=""left"">2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received:</p><p align=""left"">a. Chemotherapy or whole body radiotherapy,</p><p align=""left"">b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,</p><p align=""left"">c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin),</p><p align=""left"">d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR</p><p align=""left"">3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR</p><p align=""left"">4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR</p><p align=""left"">5. People with disability with multiple comorbidities and/or frailty.</p><p align=""left"">Details of the patient&apos;s medical condition necessitating use of this drug must be recorded in the patient&apos;s medical records</p> <p align=""justify"">For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p> <p align=""justify"">For the purpose of administering this restriction, the contraindications to nirmatrelvir (&amp;) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.</p><p align=""justify"">Details/reasons of contraindications to nirmatrelvir (&amp;) ritonavir must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND</p> <p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must have at least one sign or symptom attributable to COVID-19; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>Patient must satisfy at least one of the following criteria: (i) be moderately to severely immunocompromised with risk of progression to severe COVID-19 disease due to the immunocompromised status, (ii) has experienced past COVID-19 infection resulting in hospitalisation; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">For the purpose of administering this restriction, &apos;moderately to severely immunocompromised&apos; patients are those with:</p><p align=""left"">1. Any primary or acquired immunodeficiency including:</p><p align=""left"">a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders,</p><p align=""left"">b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),</p><p align=""left"">c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR</p><p align=""left"">2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received:</p><p align=""left"">a. Chemotherapy or whole body radiotherapy,</p><p align=""left"">b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,</p><p align=""left"">c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin),</p><p align=""left"">d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR</p><p align=""left"">3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR</p><p align=""left"">4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR</p><p align=""left"">5. People with disability with multiple comorbidities and/or frailty.</p><p align=""left"">Details of the patient&apos;s medical condition necessitating use of this drug must be recorded in the patient&apos;s medical records</p> <p align=""justify"">For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p> <p align=""justify"">For the purpose of administering this restriction, the contraindications to nirmatrelvir (&amp;) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.</p><p align=""justify"">Details/reasons of contraindications to nirmatrelvir (&amp;) ritonavir must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16199_16201_R","null","STREAMLINED","16201","16199","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND</p> <p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must have at least one sign or symptom attributable to COVID-19; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; AND</p> <p>Patient must be both: (i) at least 50 years of age, (ii) at high risk.</p> <p align=""left"">For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions:</p><p align=""left"">1. The patient is in residential aged care,</p><p align=""left"">2. The patient has disability with multiple comorbidities and/or frailty,</p><p align=""left"">3. Neurological conditions, including stroke and dementia and demyelinating conditions,</p><p align=""left"">4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease,</p><p align=""left"">5. Heart failure, coronary artery disease, cardiomyopathies,</p><p align=""left"">6. Obesity (BMI greater than 30 kg/m<sup>2</sup>),</p><p align=""left"">7. Diabetes type I or II, requiring medication for glycaemic control,</p><p align=""left"">8. Renal impairment (eGFR less than 60mL/min),</p><p align=""left"">9. Cirrhosis, or</p><p align=""left"">10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.</p><p align=""left"">Details of the patient&apos;s medical condition necessitating use of this drug must be recorded in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p> <p align=""justify"">For the purpose of administering this restriction, the contraindications to nirmatrelvir (&amp;) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.</p><p align=""justify"">Details/reasons of contraindications to nirmatrelvir (&amp;) ritonavir must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND</p> <p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must have at least one sign or symptom attributable to COVID-19; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; AND</p> <p>Patient must be both: (i) at least 50 years of age, (ii) at high risk.</p> <p align=""left"">For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions:</p><p align=""left"">1. The patient is in residential aged care,</p><p align=""left"">2. The patient has disability with multiple comorbidities and/or frailty,</p><p align=""left"">3. Neurological conditions, including stroke and dementia and demyelinating conditions,</p><p align=""left"">4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease,</p><p align=""left"">5. Heart failure, coronary artery disease, cardiomyopathies,</p><p align=""left"">6. Obesity (BMI greater than 30 kg/m<sup>2</sup>),</p><p align=""left"">7. Diabetes type I or II, requiring medication for glycaemic control,</p><p align=""left"">8. Renal impairment (eGFR less than 60mL/min),</p><p align=""left"">9. Cirrhosis, or</p><p align=""left"">10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.</p><p align=""left"">Details of the patient&apos;s medical condition necessitating use of this drug must be recorded in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p> <p align=""justify"">For the purpose of administering this restriction, the contraindications to nirmatrelvir (&amp;) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.</p><p align=""justify"">Details/reasons of contraindications to nirmatrelvir (&amp;) ritonavir must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The Modified Monash Model categorises an area according to geographical remoteness and town size. Details can be found at: https://www.health.gov.au/health-topics/rural-health-workforce/classifications/mmm</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16202_16155_R","null","STREAMLINED","16155","16202","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; or</p> <p>The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic; AND</p> <p>Patient must be at least 70 years of age.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; or</p> <p>The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic; AND</p> <p>Patient must be at least 70 years of age.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16203_15311_R","null","STREAMLINED","15311","16203","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor.</p> <p align=""justify"">Definition:</p><p align=""justify"">A HbA1c measurement greater than 7% despite treatment with the specified prior therapy/therapies indicates inadequate responsiveness. Where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2-week period indicates inadequate responsiveness.</p><p align=""justify"">Blood glucose monitoring is an alternative to HbA1c measurement where at least one of the following circumstances applies:</p><p align=""justify"">(a) A clinical condition with reduced red blood cell survival (inclusive of haemolytic anaemias, haemoglobinopathies),</p><p align=""justify"">(b) Red cell transfusion within the previous 3 months.</p><p align=""justify"">Document HbA1c measurements (blood glucose measurements where relevant), as well as any intolerances/contraindications in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16205_16186_R","null","AUTHORITY_REQUIRED","16186","16205","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have an established pituitary or testicular disorder; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have an established pituitary or testicular disorder; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16209_16156_R","null","STREAMLINED","16156","16209","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must have at least one sign or symptom attributable to COVID-19; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; AND</p> <p>Patient must be both: (i) at least 50 years of age, (ii) at high risk.</p> <p align=""left"">For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions:</p><p align=""left"">1. The patient is in residential aged care,</p><p align=""left"">2. The patient has disability with multiple comorbidities and/or frailty,</p><p align=""left"">3. Neurological conditions, including stroke and dementia and demyelinating conditions,</p><p align=""left"">4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease,</p><p align=""left"">5. Heart failure, coronary artery disease, cardiomyopathies,</p><p align=""left"">6. Obesity (BMI greater than 30 kg/m<sup>2</sup>),</p><p align=""left"">7. Diabetes type I or II, requiring medication for glycaemic control,</p><p align=""left"">8. Renal impairment (eGFR less than 60mL/min),</p><p align=""left"">9. Cirrhosis, or</p><p align=""left"">10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.</p><p align=""left"">Details of the patient&apos;s medical condition necessitating use of this drug must be recorded in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must have at least one sign or symptom attributable to COVID-19; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; AND</p> <p>Patient must be both: (i) at least 50 years of age, (ii) at high risk.</p> <p align=""left"">For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions:</p><p align=""left"">1. The patient is in residential aged care,</p><p align=""left"">2. The patient has disability with multiple comorbidities and/or frailty,</p><p align=""left"">3. Neurological conditions, including stroke and dementia and demyelinating conditions,</p><p align=""left"">4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease,</p><p align=""left"">5. Heart failure, coronary artery disease, cardiomyopathies,</p><p align=""left"">6. Obesity (BMI greater than 30 kg/m<sup>2</sup>),</p><p align=""left"">7. Diabetes type I or II, requiring medication for glycaemic control,</p><p align=""left"">8. Renal impairment (eGFR less than 60mL/min),</p><p align=""left"">9. Cirrhosis, or</p><p align=""left"">10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above.</p><p align=""left"">Details of the patient&apos;s medical condition necessitating use of this drug must be recorded in the patient&apos;s medical records.</p> <p align=""justify"">For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p> <p align=""justify"">The Modified Monash Model categorises an area according to geographical remoteness and town size. Details can be found at: https://www.health.gov.au/health-topics/rural-health-workforce/classifications/mmm</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16210_16194_R","null","AUTHORITY_REQUIRED","16194","16210","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constitutional delay of growth or puberty</p><br/><p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constitutional delay of growth or puberty</p><br/><p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16213_16206_R","null","AUTHORITY_REQUIRED","16206","16213","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Micropenis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Micropenis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16215_16215_R","Initiating or recommencing treatment","AUTHORITY_REQUIRED","16215","16215","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Von Hippel-Lindau (VHL) disease</p><br/><p>Initiating or recommencing treatment</p><br/><p>The condition must have been diagnosed by at least one of: (i) a germline VHL alteration; (ii) at least two manifestations highly characteristic of VHL disease; (iii) at least one manifestation highly characteristic of VHL disease with a documented family history of VHL; AND</p> <p>The condition must be at least one of: (i) VHL-associated non-metastatic renal cell carcinoma (RCC); (ii) VHL-associated central nervous system (CNS) haemangioblastoma; (iii) VHL-associated non-metastatic pancreatic neuroendocrine tumour (pNET); AND</p> <p>Patient must not have tumour(s) that require immediate surgery as assessed by the treating clinician; AND</p> <p>Patient must be untreated with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for a different tumour type; or</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition and ceased previous treatment for family planning purposes; AND</p> <p>Patient must have WHO performance status no higher than 1; or</p> <p>The condition must be VHL-associated brainstem tumour(s), or brain herniation, which temporarily affected the patient''s WHO performance status to be higher than 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for VHL disease associated tumours; AND</p> <p>Must be treated by a physician with expertise in the management of VHL disease associated tumours.</p> <p align=""justify"">Patients who cease therapy for reasons other than, clinical disease progression or metastasis, may re-initiate PBS-subsidised treatment through the initiating or recommencing treatment phase.</p> <p align=""justify"">For the purpose of administering this restriction, the highly characteristic manifestations of VHL disease include but not limited to:</p><p align=""justify"">(i) retinal, spinal, or cerebellar haemangioblastoma;</p><p align=""justify"">(ii) adrenal or extra-adrenal phaeochromocytoma;</p><p align=""justify"">(iii) renal cell carcinoma;</p><p align=""justify"">(iv) multiple renal and pancreatic cysts;</p><p align=""justify"">(v) endolymphatic sac tumours, papillary cystadenomas of the epididymis or broad ligament, or pancreatic neuroendocrine tumours.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Von Hippel-Lindau (VHL) disease</p><br/><p>Initiating or recommencing treatment</p><br/><p>The condition must have been diagnosed by at least one of: (i) a germline VHL alteration; (ii) at least two manifestations highly characteristic of VHL disease; (iii) at least one manifestation highly characteristic of VHL disease with a documented family history of VHL; AND</p> <p>The condition must be at least one of: (i) VHL-associated non-metastatic renal cell carcinoma (RCC); (ii) VHL-associated central nervous system (CNS) haemangioblastoma; (iii) VHL-associated non-metastatic pancreatic neuroendocrine tumour (pNET); AND</p> <p>Patient must not have tumour(s) that require immediate surgery as assessed by the treating clinician; AND</p> <p>Patient must be untreated with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for a different tumour type; or</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition and ceased previous treatment for family planning purposes; AND</p> <p>Patient must have WHO performance status no higher than 1; or</p> <p>The condition must be VHL-associated brainstem tumour(s), or brain herniation, which temporarily affected the patient''s WHO performance status to be higher than 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for VHL disease associated tumours; AND</p> <p>Must be treated by a physician with expertise in the management of VHL disease associated tumours.</p> <p align=""justify"">Patients who cease therapy for reasons other than, clinical disease progression or metastasis, may re-initiate PBS-subsidised treatment through the initiating or recommencing treatment phase.</p> <p align=""justify"">For the purpose of administering this restriction, the highly characteristic manifestations of VHL disease include but not limited to:</p><p align=""justify"">(i) retinal, spinal, or cerebellar haemangioblastoma;</p><p align=""justify"">(ii) adrenal or extra-adrenal phaeochromocytoma;</p><p align=""justify"">(iii) renal cell carcinoma;</p><p align=""justify"">(iv) multiple renal and pancreatic cysts;</p><p align=""justify"">(v) endolymphatic sac tumours, papillary cystadenomas of the epididymis or broad ligament, or pancreatic neuroendocrine tumours.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16216_16216_R","Initial 1 treatment (new patient)","AUTHORITY_REQUIRED","16216","16216","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe chronic pouchitis</p><br/><p>Initial 1 treatment (new patient)</p><br/><p>Patient must have undergone ileal pouch anal anastomosis (IPAA) due to ulcerative colitis (UC) at least one year previously; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be confirmed based on the patient''s symptoms, treatment history and baseline endoscopic examination of the pouch (pouchoscopy); AND</p> <p>Patient must have a Modified Pouchitis Disease Activity Index (mPDAI) score of at least 5; AND</p> <p>Patient must have a minimum endoscopic mPDAI sub-score of at least 2; AND</p> <p>Patient must have had at least 3 recurrent episodes of pouchitis within the previous year each of which was treated with at least: (i) 2 weeks of antibiotic, (ii) other prescription therapy; or</p> <p>The condition must have required maintenance antibiotic therapy taken continuously for at least 4 weeks before commencing treatment with this drug; AND</p> <p>Patient must not receive more than 14 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>The treatment must be initiated in combination with standard of care antibiotic.</p> <p align=""justify"">The assessment of a patient&apos;s response to this initial course of treatment must be made after the third dose of vedolizumab so there is an adequate time for a response to be demonstrated. The assessment must be made prior to obtaining a PBS authority for continuing treatment from the dose at week 14. Where a response assessment is not conducted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the patient&apos;s baseline Modified Pouchitis Disease Activity Index (mPDAI) score and endoscopic mPDAI subscore; and</p><p align=""justify"">(ii) details of prior drug therapy for this condition [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">The endoscopic assessment contributing to the Modified Pouchitis Disease Activity Index score to confirm the patient&apos;s condition at baseline must have been performed no more than 4 weeks prior to the application.</p> <p align=""justify"">Applications for treatment of this condition must be received within 4 weeks of the endoscopy to confirm diagnosis.</p><p align=""justify"">The prescriber must exclude secondary causes of pouchitis, for example:</p><p align=""justify"">(a) Ischaemia;</p><p align=""justify"">(b) Crohn&apos;s disease (CD) or CD of the pouch;</p><p align=""justify"">(c) Irritable pouch syndrome;</p><p align=""justify"">(d) Predominant cuffitis;</p><p align=""justify"">(e) Pouch stricture or pouch fistula;</p><p align=""justify"">(f) Active infection;</p><p align=""justify"">(g) NSAIDs;</p><p align=""justify"">(h) Coeliac disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe chronic pouchitis</p><br/><p>Initial 1 treatment (new patient)</p><br/><p>Patient must have undergone ileal pouch anal anastomosis (IPAA) due to ulcerative colitis (UC) at least one year previously; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be confirmed based on the patient''s symptoms, treatment history and baseline endoscopic examination of the pouch (pouchoscopy); AND</p> <p>Patient must have a Modified Pouchitis Disease Activity Index (mPDAI) score of at least 5; AND</p> <p>Patient must have a minimum endoscopic mPDAI sub-score of at least 2; AND</p> <p>Patient must have had at least 3 recurrent episodes of pouchitis within the previous year each of which was treated with at least: (i) 2 weeks of antibiotic, (ii) other prescription therapy; or</p> <p>The condition must have required maintenance antibiotic therapy taken continuously for at least 4 weeks before commencing treatment with this drug; AND</p> <p>Patient must not receive more than 14 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>The treatment must be initiated in combination with standard of care antibiotic.</p> <p align=""justify"">The assessment of a patient&apos;s response to this initial course of treatment must be made after the third dose of vedolizumab so there is an adequate time for a response to be demonstrated. The assessment must be made prior to obtaining a PBS authority for continuing treatment from the dose at week 14. Where a response assessment is not conducted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the patient&apos;s baseline Modified Pouchitis Disease Activity Index (mPDAI) score and endoscopic mPDAI subscore; and</p><p align=""justify"">(ii) details of prior drug therapy for this condition [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">The endoscopic assessment contributing to the Modified Pouchitis Disease Activity Index score to confirm the patient&apos;s condition at baseline must have been performed no more than 4 weeks prior to the application.</p> <p align=""justify"">Applications for treatment of this condition must be received within 4 weeks of the endoscopy to confirm diagnosis.</p><p align=""justify"">The prescriber must exclude secondary causes of pouchitis, for example:</p><p align=""justify"">(a) Ischaemia;</p><p align=""justify"">(b) Crohn&apos;s disease (CD) or CD of the pouch;</p><p align=""justify"">(c) Irritable pouch syndrome;</p><p align=""justify"">(d) Predominant cuffitis;</p><p align=""justify"">(e) Pouch stricture or pouch fistula;</p><p align=""justify"">(f) Active infection;</p><p align=""justify"">(g) NSAIDs;</p><p align=""justify"">(h) Coeliac disease.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2024-12-01","Y","4708"
"16219_16190_R","null","STREAMLINED","16190","16219","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND</p> <p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; or</p> <p>The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic; AND</p> <p>Patient must be at least 70 years of age.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p> <p align=""justify"">For the purpose of administering this restriction, the contraindications to nirmatrelvir (&amp;) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.</p><p align=""justify"">Details/reasons of contraindications to nirmatrelvir (&amp;) ritonavir must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>SARS-CoV-2 infection</p><br/><p>The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND</p> <p>Patient must have received a positive nucleic acid test result; or</p> <p>Patient must have received a positive rapid antigen test (RAT) result; AND</p> <p>Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND</p> <p>The treatment must be initiated within 5 days of symptom onset; or</p> <p>The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic; AND</p> <p>Patient must be at least 70 years of age.</p> <p align=""justify"">Access to this drug through this restriction is permitted irrespective of vaccination status.</p> <p align=""justify"">Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.</p> <p align=""justify"">Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.</p> <p align=""justify"">This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.</p> <p align=""justify"">For the purpose of administering this restriction, the contraindications to nirmatrelvir (&amp;) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.</p><p align=""justify"">Details/reasons of contraindications to nirmatrelvir (&amp;) ritonavir must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16221_16212_R","null","AUTHORITY_REQUIRED","16212","16221","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pubertal induction</p><br/><p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pubertal induction</p><br/><p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists; AND</p> <p>The treatment must be applied to the scrotum, where possible.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16222_16222_R","null","STREAMLINED","16222","16222","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p>","N","N","N","IMMEDIATE","ALL","N","2024-12-01","N","4708"
"16231_16231_R","null","STREAMLINED","16231","16231","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p> <p align=""justify"">For a patient switching from oral risperidone, the prescriber must determine the patient dosage of this drug based on the current dose of oral risperidone according to the dose transition table in the Therapeutic Goods Administration (TGA) approved Product Information.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p> <p align=""justify"">For a patient switching from oral risperidone, the prescriber must determine the patient dosage of this drug based on the current dose of oral risperidone according to the dose transition table in the Therapeutic Goods Administration (TGA) approved Product Information.</p>","N","N","N","IMMEDIATE","ALL","N","2025-01-01","N","4708"
"16235_5653_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","5653","16235","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-01-01","N","4708"
"16247_9690_R","Management (initiation, stabilisation and review of therapy )","STREAMLINED","9690","16247","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of cardiac allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy )</p><br/><p>Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of cardiac allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy )</p><br/><p>Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-01-01","N","4708"
"16250_16239_R","Initial 2 treatment (Recommencement of treatment after a break in biological medicine)","AUTHORITY_REQUIRED","16239","16250","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe chronic pouchitis</p><br/><p>Initial 2 treatment (Recommencement of treatment after a break in biological medicine)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 14 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>The treatment must be initiated in combination with standard of care antibiotic.</p> <p align=""justify"">The assessment of a patient&apos;s response to this initial course of treatment must be made after the third dose of vedolizumab so there is adequate time for a response to be demonstrated. The assessment must be made prior to obtaining a PBS authority for continuing treatment from the dose at week 14.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the details of prior biological medicine therapy for this condition [date of commencement and duration of therapy].</p> <p align=""justify"">The prescriber must have excluded secondary causes of pouchitis, for example:</p><p align=""justify"">(a) Ischaemia;</p><p align=""justify"">(b) Crohn&apos;s disease (CD) or CD of the pouch;</p><p align=""justify"">(c) Irritable pouch syndrome;</p><p align=""justify"">(d) Predominant cuffitis;</p><p align=""justify"">(e) Pouch stricture or pouch fistula;</p><p align=""justify"">(f) Active infection;</p><p align=""justify"">(g) NSAIDs;</p><p align=""justify"">(h) Coeliac disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe chronic pouchitis</p><br/><p>Initial 2 treatment (Recommencement of treatment after a break in biological medicine)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 14 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>The treatment must be initiated in combination with standard of care antibiotic.</p> <p align=""justify"">The assessment of a patient&apos;s response to this initial course of treatment must be made after the third dose of vedolizumab so there is adequate time for a response to be demonstrated. The assessment must be made prior to obtaining a PBS authority for continuing treatment from the dose at week 14.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the details of prior biological medicine therapy for this condition [date of commencement and duration of therapy].</p> <p align=""justify"">The prescriber must have excluded secondary causes of pouchitis, for example:</p><p align=""justify"">(a) Ischaemia;</p><p align=""justify"">(b) Crohn&apos;s disease (CD) or CD of the pouch;</p><p align=""justify"">(c) Irritable pouch syndrome;</p><p align=""justify"">(d) Predominant cuffitis;</p><p align=""justify"">(e) Pouch stricture or pouch fistula;</p><p align=""justify"">(f) Active infection;</p><p align=""justify"">(g) NSAIDs;</p><p align=""justify"">(h) Coeliac disease.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-01-01","Y","4708"
"16253_16238_R","Induction and Consolidation therapy","AUTHORITY_REQUIRED","16238","16253","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Induction and Consolidation therapy</p><br/><p>Patient must be newly diagnosed; AND</p> <p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>The treatment must be in combination with chemotherapy or corticosteroids; AND</p> <p>Patient must not have previously experienced a failure to respond to PBS-subsidised first-line treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first-line therapy for this condition.</p> <p align=""justify"">A pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Induction and Consolidation therapy</p><br/><p>Patient must be newly diagnosed; AND</p> <p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>The treatment must be in combination with chemotherapy or corticosteroids; AND</p> <p>Patient must not have previously experienced a failure to respond to PBS-subsidised first-line treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first-line therapy for this condition.</p> <p align=""justify"">A pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-01-01","N","4708"
"16258_9689_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","9689","16258","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-01-01","N","4708"
"16259_5600_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","5600","16259","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of cardiac allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of cardiac allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-01-01","N","4708"
"16261_16261_R","null","RESTRICTED","16261","16261","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For prescribing by certain health practitioners</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife who is each of: (a) sharing patient care with a medical practitioner for the current pregnancy episode, (b) continuing existing treatment with this drug that was initiated by a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For prescribing by certain health practitioners</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife who is each of: (a) sharing patient care with a medical practitioner for the current pregnancy episode, (b) continuing existing treatment with this drug that was initiated by a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16262_16273_R","null","AUTHORITY_REQUIRED","16273","16262","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypertension</p><br/><p>Patient must be pregnant; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife who is each of: (a) sharing patient care with a medical practitioner for the current pregnancy episode, (b) continuing existing treatment with this drug that was initiated by a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypertension</p><br/><p>Patient must be pregnant; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife who is each of: (a) sharing patient care with a medical practitioner for the current pregnancy episode, (b) continuing existing treatment with this drug that was initiated by a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16265_5893_R","null","RESTRICTED","5893","16265","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection where resistance to amoxicillin is suspected</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection where resistance to amoxicillin is suspected</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16266_5942_R","Episodic treatment or suppressive therapy","STREAMLINED","5942","16266","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment or suppressive therapy</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment or suppressive therapy</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16267_5718_R","null","RESTRICTED","5718","16267","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urethritis</p><br/><p>The condition must be uncomplicated and due to Chlamydia trachomatis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urethritis</p><br/><p>The condition must be uncomplicated and due to Chlamydia trachomatis.</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16268_16289_R","null","RESTRICTED","16289","16268","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven vitamin B12 deficiencies other than pernicious anaemia</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven vitamin B12 deficiencies other than pernicious anaemia</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16270_16270_R","null","STREAMLINED","16270","16270","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>The condition must have evidence of rearranged during transfection (RET) gene fusion in tumour material - this evidence has been obtained prior to commencing treatment with this drug; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be initiating treatment with this drug; or</p> <p>Patient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug.</p> <p align=""justify"">Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>The condition must have evidence of rearranged during transfection (RET) gene fusion in tumour material - this evidence has been obtained prior to commencing treatment with this drug; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be initiating treatment with this drug; or</p> <p>Patient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug.</p> <p align=""justify"">Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested.</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16271_5772_R","null","RESTRICTED","5772","16271","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cervicitis</p><br/><p>The condition must be uncomplicated and due to Chlamydia trachomatis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cervicitis</p><br/><p>The condition must be uncomplicated and due to Chlamydia trachomatis.</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16272_16276_R","null","RESTRICTED","16276","16272","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>The treatment must be for short term therapy of acute severe pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife who is sharing the post-operative care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>The treatment must be for short term therapy of acute severe pain; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or</p> <p>Patient must be unable to use non-opioid analgesics due to contraindications or intolerance; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife who is sharing the post-operative care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16275_5832_R","null","RESTRICTED","5832","16275","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infections where resistance to amoxicillin is proven</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infections where resistance to amoxicillin is proven</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16277_16288_R","null","RESTRICTED","16288","16277","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pernicious anaemia</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pernicious anaemia</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16278_16269_R","null","RESTRICTED","16269","16278","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaemias associated with vitamin B12 deficiency</p><br/><p>Patient must have had a gastrectomy; AND</p> <p>The treatment must be for prophylaxis; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaemias associated with vitamin B12 deficiency</p><br/><p>Patient must have had a gastrectomy; AND</p> <p>The treatment must be for prophylaxis; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16279_16279_R","null","RESTRICTED","16279","16279","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For prescribing by certain health practitioners</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For prescribing by certain health practitioners</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16281_16282_R","null","STREAMLINED","16282","16281","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>The condition must have evidence of rearranged during transfection (RET) gene fusion in tumour material - this evidence has been obtained prior to commencing treatment with this drug; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be initiating treatment with this drug; or</p> <p>Patient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug.</p> <p align=""justify"">Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Medical practitioners may prescribe selpercatinib 80 mg with a quantity of up to 56 units where the dose does not exceed 120 mg twice daily (i.e., in combination with selpercatinib 40 mg). Selpercatinib 80 mg with a quantity of 112 units must be prescribed only where the dose is 160 mg twice daily to provide 28 days of treatment per dispensing. Prescribers should refer to the TGA PI for dosing and dose adjustments regimens.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>The condition must have evidence of rearranged during transfection (RET) gene fusion in tumour material - this evidence has been obtained prior to commencing treatment with this drug; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be initiating treatment with this drug; or</p> <p>Patient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug.</p> <p align=""justify"">Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Medical practitioners may prescribe selpercatinib 80 mg with a quantity of up to 56 units where the dose does not exceed 120 mg twice daily (i.e., in combination with selpercatinib 40 mg). Selpercatinib 80 mg with a quantity of 112 units must be prescribed only where the dose is 160 mg twice daily to provide 28 days of treatment per dispensing. Prescribers should refer to the TGA PI for dosing and dose adjustments regimens.</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16286_5940_R","Suppressive therapy","STREAMLINED","5940","16286","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Suppressive therapy</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Suppressive therapy</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16287_5297_R","null","RESTRICTED","5297","16287","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious staphylococcal infection</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious staphylococcal infection</p>","N","N","N","IMMEDIATE","ALL","N","2025-02-01","N","4708"
"16293_13336_R","Continuing treatment","STREAMLINED","13336","16293","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central retinal vein occlusion with macular oedema</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central retinal vein occlusion with macular oedema</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16295_16295_R","Initial treatment","STREAMLINED","16295","16295","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial heterozygous hypercholesterolaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>The condition must have been confirmed by genetic testing; or</p> <p>The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6; AND</p> <p>Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; or</p> <p>Patient must have an LDL cholesterol level in excess of 5 millimoles per litre; AND</p> <p>Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; or</p> <p>Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND</p> <p>Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by an authorised prescriber in consultation with a specialist physician.</p> <p align=""justify"">Symptomatic atherosclerotic cardiovascular disease is defined as:</p><p align=""justify"">(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or</p><p align=""justify"">(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or</p><p align=""justify"">(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).</p> <p align=""justify"">The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient&apos;s medical records and must be no more than 8 weeks old.</p> <p align=""justify"">A clinically important product-related adverse event is defined as follows: </p><p align=""justify"">(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or </p><p align=""justify"">(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or </p><p align=""justify"">(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.</p> <p align=""justify"">If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.</p> <p align=""justify"">In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(i) the qualifying Dutch Lipid Clinic Network Score; or</p><p align=""justify"">(ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia</p> <p align=""justify"">One of the following must be documented in the patient&apos;s medical records regarding prior statin treatment:</p><p align=""justify"">(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or</p><p align=""justify"">(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or</p><p align=""justify"">(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.</p> <p align=""justify"">Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial heterozygous hypercholesterolaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>The condition must have been confirmed by genetic testing; or</p> <p>The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6; AND</p> <p>Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; or</p> <p>Patient must have an LDL cholesterol level in excess of 5 millimoles per litre; AND</p> <p>Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; or</p> <p>Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND</p> <p>Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by an authorised prescriber in consultation with a specialist physician.</p> <p align=""justify"">Symptomatic atherosclerotic cardiovascular disease is defined as:</p><p align=""justify"">(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or</p><p align=""justify"">(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or</p><p align=""justify"">(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).</p> <p align=""justify"">The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient&apos;s medical records and must be no more than 8 weeks old.</p> <p align=""justify"">A clinically important product-related adverse event is defined as follows: </p><p align=""justify"">(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or </p><p align=""justify"">(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or </p><p align=""justify"">(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.</p> <p align=""justify"">If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.</p> <p align=""justify"">In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(i) the qualifying Dutch Lipid Clinic Network Score; or</p><p align=""justify"">(ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia</p> <p align=""justify"">One of the following must be documented in the patient&apos;s medical records regarding prior statin treatment:</p><p align=""justify"">(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or</p><p align=""justify"">(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or</p><p align=""justify"">(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.</p> <p align=""justify"">Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16296_16321_R","Initial treatment","STREAMLINED","16321","16296","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16298_16345_R","Initial treatment","STREAMLINED","16345","16298","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsing remitting multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed by a neurologist; AND</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p> <p align=""justify"">The prescriber should write authority prescriptions for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsing remitting multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed by a neurologist; AND</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p> <p align=""justify"">The prescriber should write authority prescriptions for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16300_16301_R","Continuing treatment","STREAMLINED","16301","16300","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16302_16303_R","Continuing treatment (including recommencement of treatment)","STREAMLINED","16303","16302","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment (including recommencement of treatment)</p><br/><p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must be ambulatory, with/without assistance/support; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment (including recommencement of treatment)</p><br/><p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must be ambulatory, with/without assistance/support; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16304_16338_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","16338","16304","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-03-01","Y","4708"
"16306_16306_R","Initial treatment","AUTHORITY_REQUIRED","16306","16306","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endogenous Cushing''s syndrome</p><br/><p>Initial treatment</p><br/><p>The condition must be at least one of: (i) persistent hypercortisolism after surgery, (ii) recurrent hypercortisolism after surgery, (iii) inappropriate for surgery; AND</p> <p>Patient must have active endogenous Cushing''s Syndrome determined by a mean urinary free cortisol (UFC) level greater than 1.3 times the upper limit of normal (ULN); or</p> <p>Patient must have undergone treatment for this condition with conventional therapies to control cortisol production resulting in an improved UFC level prior to applying for the initial authority application of this drug; AND</p> <p>Must be treated by an endocrinologist; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">For the purposes of administering this restriction, the mean UFC is the average of at least two values being 1.3 times greater than the ULN.</p> <p align=""justify"">Patient must undergo a dose titration period whereby responses must be assessed every 1-2 weeks until the mean UFC levels are within the normal range.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of packs to provide sufficient drug, based on the prescribed dose of the patient, for 4 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested. The dose must not exceed 30 mg twice daily. Up to a maximum of 6 repeats will be authorised.</p> <p align=""justify"">Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the dose is changing), mark the prescription that is intended for no further supply as &apos;Cancelled&apos;.</p> <p align=""justify"">The condition is inappropriate for surgery if the patient:</p><p align=""left"">(i) has a medical contraindication for surgery;</p><p align=""justify"">(ii) has inoperable tumours;</p><p align=""justify"">(iii) has been determined that surgery is unlikely to reduce hypercortisolism;</p><p align=""justify"">(iv) refuses surgery;</p><p align=""justify"">(v) cannot access surgical treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endogenous Cushing''s syndrome</p><br/><p>Initial treatment</p><br/><p>The condition must be at least one of: (i) persistent hypercortisolism after surgery, (ii) recurrent hypercortisolism after surgery, (iii) inappropriate for surgery; AND</p> <p>Patient must have active endogenous Cushing''s Syndrome determined by a mean urinary free cortisol (UFC) level greater than 1.3 times the upper limit of normal (ULN); or</p> <p>Patient must have undergone treatment for this condition with conventional therapies to control cortisol production resulting in an improved UFC level prior to applying for the initial authority application of this drug; AND</p> <p>Must be treated by an endocrinologist; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">For the purposes of administering this restriction, the mean UFC is the average of at least two values being 1.3 times greater than the ULN.</p> <p align=""justify"">Patient must undergo a dose titration period whereby responses must be assessed every 1-2 weeks until the mean UFC levels are within the normal range.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of packs to provide sufficient drug, based on the prescribed dose of the patient, for 4 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested. The dose must not exceed 30 mg twice daily. Up to a maximum of 6 repeats will be authorised.</p> <p align=""justify"">Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the dose is changing), mark the prescription that is intended for no further supply as &apos;Cancelled&apos;.</p> <p align=""justify"">The condition is inappropriate for surgery if the patient:</p><p align=""left"">(i) has a medical contraindication for surgery;</p><p align=""justify"">(ii) has inoperable tumours;</p><p align=""justify"">(iii) has been determined that surgery is unlikely to reduce hypercortisolism;</p><p align=""justify"">(iv) refuses surgery;</p><p align=""justify"">(v) cannot access surgical treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16310_13387_R","Continuing treatment","STREAMLINED","13387","16310","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Branch retinal vein occlusion with macular oedema</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Branch retinal vein occlusion with macular oedema</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16311_16336_R","Continuing treatment with this drug or switching treatment from any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran","STREAMLINED","16336","16311","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-familial hypercholesterolaemia</p><br/><p>Continuing treatment with this drug or switching treatment from any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have received PBS-subsidised treatment for this PBS indication with any of: (i) a drug from the same pharmacological class as this drug (ii) inclisiran; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran, for this PBS indication; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-familial hypercholesterolaemia</p><br/><p>Continuing treatment with this drug or switching treatment from any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have received PBS-subsidised treatment for this PBS indication with any of: (i) a drug from the same pharmacological class as this drug (ii) inclisiran; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran, for this PBS indication; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16313_16315_R","Continuing treatment","STREAMLINED","16315","16313","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16314_16323_R","Initial treatment","STREAMLINED","16323","16314","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16316_16317_R","Continuing treatment","AUTHORITY_REQUIRED","16317","16316","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endogenous Cushing''s syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a complete response after at least 26 weeks of treatment with this drug; or</p> <p>Patient must have demonstrated a partial response after at least 26 weeks of treatment with this drug; AND</p> <p>Must be treated by an endocrinologist; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">For the purposes of administering this restriction, a complete response is defined as a mean urinary free cortisol (UFC) level of less than or equal to the upper limit of normal (ULN).</p><p align=""justify"">A partial response is defined as mean UFC level of greater than ULN but with at least 50% reduction from the baseline value. The mean UFC should be the average of at least two urine samples.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of packs to provide sufficient drug, based on the prescribed dose of the patient, for 4 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested. The dose must not exceed 30 mg twice daily. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the dose is changing), mark the prescription that is intended for no further supply as &apos;Cancelled&apos;.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted after 26 weeks from the first dose of osilodrostat and no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for patients who meet the continuing restriction for PBS-subsidised treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endogenous Cushing''s syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a complete response after at least 26 weeks of treatment with this drug; or</p> <p>Patient must have demonstrated a partial response after at least 26 weeks of treatment with this drug; AND</p> <p>Must be treated by an endocrinologist; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">For the purposes of administering this restriction, a complete response is defined as a mean urinary free cortisol (UFC) level of less than or equal to the upper limit of normal (ULN).</p><p align=""justify"">A partial response is defined as mean UFC level of greater than ULN but with at least 50% reduction from the baseline value. The mean UFC should be the average of at least two urine samples.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of packs to provide sufficient drug, based on the prescribed dose of the patient, for 4 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested. The dose must not exceed 30 mg twice daily. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the dose is changing), mark the prescription that is intended for no further supply as &apos;Cancelled&apos;.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted after 26 weeks from the first dose of osilodrostat and no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for patients who meet the continuing restriction for PBS-subsidised treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16322_16299_R","Continuing treatment","STREAMLINED","16299","16322","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsing remitting multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate, this therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p> <p align=""justify"">The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsing remitting multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate, this therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p> <p align=""justify"">The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16324_16297_R","Continuing treatment","STREAMLINED","16297","16324","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16326_16340_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","16340","16326","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16329_16350_R","Continuing treatment with this drug or switching treatment from any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran","STREAMLINED","16350","16329","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial heterozygous hypercholesterolaemia</p><br/><p>Continuing treatment with this drug or switching treatment from any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have received PBS-subsidised treatment for this PBS indication with any of: (i) a drug from the same pharmacological class as this drug (ii) inclisiran; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran, for this PBS indication; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial heterozygous hypercholesterolaemia</p><br/><p>Continuing treatment with this drug or switching treatment from any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have received PBS-subsidised treatment for this PBS indication with any of: (i) a drug from the same pharmacological class as this drug (ii) inclisiran; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran, for this PBS indication; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16330_16294_R","Initial treatment","STREAMLINED","16294","16330","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial heterozygous hypercholesterolaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>The condition must have been confirmed by genetic testing; or</p> <p>The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6; AND</p> <p>Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; or</p> <p>Patient must have an LDL cholesterol level in excess of 5 millimoles per litre; AND</p> <p>Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; or</p> <p>Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND</p> <p>Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9), (ii) inclisiran, for this PBS indication; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by an authorised prescriber in consultation with a specialist physician.</p> <p align=""justify"">Symptomatic atherosclerotic cardiovascular disease is defined as:</p><p align=""justify"">(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or</p><p align=""justify"">(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or</p><p align=""justify"">(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).</p> <p align=""justify"">The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient&apos;s medical records and must be no more than 8 weeks old.</p> <p align=""justify"">A clinically important product-related adverse event is defined as follows: </p><p align=""justify"">(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or </p><p align=""justify"">(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or </p><p align=""justify"">(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.</p> <p align=""justify"">If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.</p> <p align=""justify"">In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(i) the qualifying Dutch Lipid Clinic Network Score; or</p><p align=""justify"">(ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia</p> <p align=""justify"">One of the following must be documented in the patient&apos;s medical records regarding prior statin treatment:</p><p align=""justify"">(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or</p><p align=""justify"">(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or</p><p align=""justify"">(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.</p> <p align=""justify"">Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial heterozygous hypercholesterolaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>The condition must have been confirmed by genetic testing; or</p> <p>The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6; AND</p> <p>Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; or</p> <p>Patient must have an LDL cholesterol level in excess of 5 millimoles per litre; AND</p> <p>Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; or</p> <p>Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND</p> <p>Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9), (ii) inclisiran, for this PBS indication; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by an authorised prescriber in consultation with a specialist physician.</p> <p align=""justify"">Symptomatic atherosclerotic cardiovascular disease is defined as:</p><p align=""justify"">(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or</p><p align=""justify"">(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or</p><p align=""justify"">(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).</p> <p align=""justify"">The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient&apos;s medical records and must be no more than 8 weeks old.</p> <p align=""justify"">A clinically important product-related adverse event is defined as follows: </p><p align=""justify"">(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or </p><p align=""justify"">(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or </p><p align=""justify"">(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.</p> <p align=""justify"">If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.</p> <p align=""justify"">In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(i) the qualifying Dutch Lipid Clinic Network Score; or</p><p align=""justify"">(ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia</p> <p align=""justify"">One of the following must be documented in the patient&apos;s medical records regarding prior statin treatment:</p><p align=""justify"">(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or</p><p align=""justify"">(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or</p><p align=""justify"">(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.</p> <p align=""justify"">Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16331_16331_R","Initial treatment","STREAMLINED","16331","16331","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-familial hypercholesterolaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must have symptomatic atherosclerotic cardiovascular disease; AND</p> <p>Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND</p> <p>Patient must have atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or</p> <p>Patient must have severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or</p> <p>Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or</p> <p>Patient must have diabetes mellitus with microalbuminuria; or</p> <p>Patient must have diabetes mellitus and be aged 60 years or more; or</p> <p>Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; or</p> <p>Patient must have a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher; AND</p> <p>Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; or</p> <p>Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND</p> <p>Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by an authorised prescriber in consultation with a specialist physician.</p> <p align=""justify"">Symptomatic atherosclerotic cardiovascular disease is defined as:</p><p align=""justify"">(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or</p><p align=""justify"">(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or</p><p align=""justify"">(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).</p> <p align=""justify"">The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient&apos;s medical records and must be no more than 8 weeks old.</p> <p align=""justify"">A clinically important product-related adverse event is defined as follows: </p><p align=""justify"">(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or </p><p align=""justify"">(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or </p><p align=""justify"">(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.</p> <p align=""justify"">If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.</p> <p align=""justify"">In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.</p> <p align=""justify"">One of the following must be documented in the patient&apos;s medical records regarding prior statin treatment:</p><p align=""justify"">(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or</p><p align=""justify"">(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or</p><p align=""justify"">(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.</p> <p align=""justify"">One or more of the following must be documented in the patient&apos;s medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event:</p><p align=""justify"">(i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or</p><p align=""justify"">(ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or</p><p align=""justify"">(iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or</p><p align=""justify"">(iv) diabetes mellitus with microalbuminuria; or</p><p align=""justify"">(v) diabetes mellitus and age 60 years or more; or</p><p align=""justify"">(vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or</p><p align=""justify"">(vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher.</p> <p align=""justify"">Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-familial hypercholesterolaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must have symptomatic atherosclerotic cardiovascular disease; AND</p> <p>Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND</p> <p>Patient must have atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or</p> <p>Patient must have severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or</p> <p>Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or</p> <p>Patient must have diabetes mellitus with microalbuminuria; or</p> <p>Patient must have diabetes mellitus and be aged 60 years or more; or</p> <p>Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; or</p> <p>Patient must have a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher; AND</p> <p>Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; or</p> <p>Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND</p> <p>Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by an authorised prescriber in consultation with a specialist physician.</p> <p align=""justify"">Symptomatic atherosclerotic cardiovascular disease is defined as:</p><p align=""justify"">(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or</p><p align=""justify"">(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or</p><p align=""justify"">(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).</p> <p align=""justify"">The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient&apos;s medical records and must be no more than 8 weeks old.</p> <p align=""justify"">A clinically important product-related adverse event is defined as follows: </p><p align=""justify"">(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or </p><p align=""justify"">(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or </p><p align=""justify"">(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.</p> <p align=""justify"">If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.</p> <p align=""justify"">In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.</p> <p align=""justify"">One of the following must be documented in the patient&apos;s medical records regarding prior statin treatment:</p><p align=""justify"">(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or</p><p align=""justify"">(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or</p><p align=""justify"">(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.</p> <p align=""justify"">One or more of the following must be documented in the patient&apos;s medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event:</p><p align=""justify"">(i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or</p><p align=""justify"">(ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or</p><p align=""justify"">(iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or</p><p align=""justify"">(iv) diabetes mellitus with microalbuminuria; or</p><p align=""justify"">(v) diabetes mellitus and age 60 years or more; or</p><p align=""justify"">(vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or</p><p align=""justify"">(vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher.</p> <p align=""justify"">Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16332_16347_R","Initial treatment","STREAMLINED","16347","16332","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of at least one of the brain/spinal cord; or</p> <p>The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis supported by written certification, which is documented in the patient''s medical records, from a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory, with/without assistance/support; AND</p> <p>Patient must have mild disability in at least 3 functional systems; or</p> <p>Patient must have moderate disability in at least 1 functional system; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p> <p align=""justify"">Functional systems referred to in this restriction are the: visual, brain stem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral/cognitive systems.</p> <p align=""justify"">Select a dose and pack size appropriate for the patient&apos;s CYP2C9 metabolising enzyme status.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of at least one of the brain/spinal cord; or</p> <p>The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis supported by written certification, which is documented in the patient''s medical records, from a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory, with/without assistance/support; AND</p> <p>Patient must have mild disability in at least 3 functional systems; or</p> <p>Patient must have moderate disability in at least 1 functional system; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p> <p align=""justify"">Functional systems referred to in this restriction are the: visual, brain stem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral/cognitive systems.</p> <p align=""justify"">Select a dose and pack size appropriate for the patient&apos;s CYP2C9 metabolising enzyme status.</p> <p align=""justify"">There is no specific Medical Benefits Schedule item for CYP2C9 metabolising enzyme status testing.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16335_16319_R","Initial treatment","AUTHORITY_REQUIRED","16319","16335","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Branch retinal vein occlusion with macular oedema</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Branch retinal vein occlusion with macular oedema</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","N","N","N","FULL","ALL","N","2025-03-01","Y","4708"
"16337_16356_R","Continuing treatment with this drug or switching treatment from a monoclonal antibody inhibiting proprotein coverase subtilisin kexin type 9 (PSCK9) for this PBS indication","STREAMLINED","16356","16337","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-familial hypercholesterolaemia</p><br/><p>Continuing treatment with this drug or switching treatment from a monoclonal antibody inhibiting proprotein coverase subtilisin kexin type 9 (PSCK9) for this PBS indication</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-familial hypercholesterolaemia</p><br/><p>Continuing treatment with this drug or switching treatment from a monoclonal antibody inhibiting proprotein coverase subtilisin kexin type 9 (PSCK9) for this PBS indication</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16342_16309_R","Initial treatment","AUTHORITY_REQUIRED","16309","16342","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central retinal vein occlusion with macular oedema</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central retinal vein occlusion with macular oedema</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","N","N","N","FULL","ALL","N","2025-03-01","Y","4708"
"16343_16351_R","Initial treatment","STREAMLINED","16351","16343","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-familial hypercholesterolaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must have symptomatic atherosclerotic cardiovascular disease; AND</p> <p>Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND</p> <p>Patient must have atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or</p> <p>Patient must have severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or</p> <p>Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or</p> <p>Patient must have diabetes mellitus with microalbuminuria; or</p> <p>Patient must have diabetes mellitus and be aged 60 years or more; or</p> <p>Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; or</p> <p>Patient must have a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher; AND</p> <p>Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; or</p> <p>Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND</p> <p>Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9), (ii) inclisiran, for this PBS indication; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by an authorised prescriber in consultation with a specialist physician.</p> <p align=""justify"">Symptomatic atherosclerotic cardiovascular disease is defined as:</p><p align=""justify"">(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or</p><p align=""justify"">(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or</p><p align=""justify"">(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).</p> <p align=""justify"">The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient&apos;s medical records and must be no more than 8 weeks old.</p> <p align=""justify"">A clinically important product-related adverse event is defined as follows: </p><p align=""justify"">(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or </p><p align=""justify"">(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or </p><p align=""justify"">(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.</p> <p align=""justify"">If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.</p> <p align=""justify"">In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.</p> <p align=""justify"">One of the following must be documented in the patient&apos;s medical records regarding prior statin treatment:</p><p align=""justify"">(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or</p><p align=""justify"">(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or</p><p align=""justify"">(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.</p> <p align=""justify"">One or more of the following must be documented in the patient&apos;s medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event:</p><p align=""justify"">(i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or</p><p align=""justify"">(ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or</p><p align=""justify"">(iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or</p><p align=""justify"">(iv) diabetes mellitus with microalbuminuria; or</p><p align=""justify"">(v) diabetes mellitus and age 60 years of more; or</p><p align=""justify"">(vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or</p><p align=""justify"">(vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher</p> <p align=""justify"">Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-familial hypercholesterolaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must have symptomatic atherosclerotic cardiovascular disease; AND</p> <p>Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND</p> <p>Patient must have atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or</p> <p>Patient must have severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or</p> <p>Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or</p> <p>Patient must have diabetes mellitus with microalbuminuria; or</p> <p>Patient must have diabetes mellitus and be aged 60 years or more; or</p> <p>Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; or</p> <p>Patient must have a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher; AND</p> <p>Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; or</p> <p>Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND</p> <p>Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9), (ii) inclisiran, for this PBS indication; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by an authorised prescriber in consultation with a specialist physician.</p> <p align=""justify"">Symptomatic atherosclerotic cardiovascular disease is defined as:</p><p align=""justify"">(i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or</p><p align=""justify"">(ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or</p><p align=""justify"">(iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).</p> <p align=""justify"">The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient&apos;s medical records and must be no more than 8 weeks old.</p> <p align=""justify"">A clinically important product-related adverse event is defined as follows: </p><p align=""justify"">(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or </p><p align=""justify"">(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or </p><p align=""justify"">(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.</p> <p align=""justify"">If treatment with atorvastatin or rosuvastatin results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.</p> <p align=""justify"">In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.</p> <p align=""justify"">One of the following must be documented in the patient&apos;s medical records regarding prior statin treatment:</p><p align=""justify"">(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or</p><p align=""justify"">(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or</p><p align=""justify"">(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.</p> <p align=""justify"">One or more of the following must be documented in the patient&apos;s medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event:</p><p align=""justify"">(i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or</p><p align=""justify"">(ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or</p><p align=""justify"">(iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or</p><p align=""justify"">(iv) diabetes mellitus with microalbuminuria; or</p><p align=""justify"">(v) diabetes mellitus and age 60 years of more; or</p><p align=""justify"">(vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or</p><p align=""justify"">(vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher</p> <p align=""justify"">Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16344_16320_R","Continuing treatment with this drug or switching treatment from a monoclonal antibody inhibiting proprotein coverase subtilisin kexin type 9 (PSCK9) for this PBS indication","STREAMLINED","16320","16344","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial heterozygous hypercholesterolaemia</p><br/><p>Continuing treatment with this drug or switching treatment from a monoclonal antibody inhibiting proprotein coverase subtilisin kexin type 9 (PSCK9) for this PBS indication</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial heterozygous hypercholesterolaemia</p><br/><p>Continuing treatment with this drug or switching treatment from a monoclonal antibody inhibiting proprotein coverase subtilisin kexin type 9 (PSCK9) for this PBS indication</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have previously received PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16353_16325_R","Initial treatment","STREAMLINED","16325","16353","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician; AND</p> <p>Patient must weigh 40 kg or less.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician; AND</p> <p>Patient must weigh 40 kg or less.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16354_16346_R","Continuing treatment","STREAMLINED","16346","16354","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Patient must weigh 40 kg or less; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Patient must weigh 40 kg or less; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner in consultation with a specialist physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-03-01","N","4708"
"16355_16339_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","16339","16355","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-03-01","Y","4708"
"16361_16371_R","null","AUTHORITY_REQUIRED","16371","16361","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paediatric high grade glioma</p><br/><p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paediatric high grade glioma</p><br/><p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16363_16363_R","Initial treatment","AUTHORITY_REQUIRED","16363","16363","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk and intermediate-2 risk myelofibrosis</p><br/><p>Initial treatment</p><br/><p>The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report; AND</p> <p>Patient must have a haemoglobin level of less than 100 g per L prior to commencing treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.</p> <p align=""justify"">Details of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and</p><p align=""justify"">(b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk and intermediate-2 risk myelofibrosis</p><br/><p>Initial treatment</p><br/><p>The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report; AND</p> <p>Patient must have a haemoglobin level of less than 100 g per L prior to commencing treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.</p> <p align=""justify"">Details of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and</p><p align=""justify"">(b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.</p>","N","N","N","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16366_16365_R","Initial treatment","AUTHORITY_REQUIRED","16365","16366","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intermediate-1 risk myelofibrosis</p><br/><p>Initial treatment</p><br/><p>The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report; AND</p> <p>Patient must have severe disease-related symptoms that are resistant, refractory or intolerant to available therapy; or</p> <p>Patient must have intolerance to prior treatment with a JAK inhibitor for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.</p> <p align=""justify"">Details of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and</p><p align=""justify"">(b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intermediate-1 risk myelofibrosis</p><br/><p>Initial treatment</p><br/><p>The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report; AND</p> <p>Patient must have severe disease-related symptoms that are resistant, refractory or intolerant to available therapy; or</p> <p>Patient must have intolerance to prior treatment with a JAK inhibitor for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.</p> <p align=""justify"">Details of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and</p><p align=""justify"">(b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.</p>","N","N","N","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16366_C","null","null","null","null","null","<p align=""justify"">Hepatotoxicity has been reported with this drug.</p>","N","Y","N","null","null","N","2015-07-01","N","4708"
"16368_16368_R","Continuing treatment","AUTHORITY_REQUIRED","16368","16368","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neuromyelitis optica spectrum disorder (NMOSD)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have an Expanded Disability Status Scale (EDSS) score of no higher than 7; AND</p> <p>Patient must not have experienced a relapse while receiving treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a medical practitioner who has consulted a neurologist, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 8 weeks of treatment and up to 2 repeats, according to the specified dosage in the approved Product Information (PI). With 2 repeat prescriptions, this treatment phase listing intends to provide approximately 24 weeks of treatment.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neuromyelitis optica spectrum disorder (NMOSD)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have an Expanded Disability Status Scale (EDSS) score of no higher than 7; AND</p> <p>Patient must not have experienced a relapse while receiving treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a medical practitioner who has consulted a neurologist, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 8 weeks of treatment and up to 2 repeats, according to the specified dosage in the approved Product Information (PI). With 2 repeat prescriptions, this treatment phase listing intends to provide approximately 24 weeks of treatment.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16372_16372_R","null","AUTHORITY_REQUIRED","16372","16372","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paediatric low grade glioma</p><br/><p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paediatric low grade glioma</p><br/><p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16376_16391_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16391","16376","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-04-01","Y","4708"
"16378_16378_R","Continuing treatment","AUTHORITY_REQUIRED","16378","16378","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paediatric high grade glioma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have either: (i) stable, (ii) responding disease based on the Response Assessment in Neuro-Oncology (RANO) criteria; AND</p> <p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paediatric high grade glioma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have either: (i) stable, (ii) responding disease based on the Response Assessment in Neuro-Oncology (RANO) criteria; AND</p> <p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition.</p> <p align=""justify"">Response in the proposed restrictions is assessed using the Response Assessment for Neuro-Oncology (RANO) 2017 criteria:</p><p align=""justify"">Wen PY, Chang SM, Van den Bent MJ, Vogelbaum MA, Macdonald DR, Lee EQ. Response Assessment in Neuro-Oncology Clinical Trials. J Clin Oncol. 2017;35(21):2439-2449. doi:10.1200/JCO.2017.72.7511</p>","N","N","N","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16379_16364_R","Initial treatment","AUTHORITY_REQUIRED","16364","16379","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk and intermediate-2 risk myelofibrosis</p><br/><p>Initial treatment</p><br/><p>The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report; AND</p> <p>The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.</p> <p align=""justify"">Details of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and</p><p align=""justify"">(b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk and intermediate-2 risk myelofibrosis</p><br/><p>Initial treatment</p><br/><p>The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report; AND</p> <p>The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.</p> <p align=""justify"">Details of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and</p><p align=""justify"">(b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.</p>","N","N","N","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16381_16382_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16382","16381","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p>The assessment of the patient&apos;s response to this initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted to the Department of Human Services no later than 4 weeks from the cessation of the treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-04-01","Y","4708"
"16383_16370_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16370","16383","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-04-01","Y","4708"
"16384_16392_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16392","16384","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-04-01","Y","4708"
"16385_16385_R","Initial treatment","AUTHORITY_REQUIRED","16385","16385","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paediatric high grade glioma</p><br/><p>Initial treatment</p><br/><p>The condition must be World Health Organisation (WHO) grade 3 or 4; AND</p> <p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>Patient must have either a: (i) Karnofsky, (ii) Lansky performance score of at least 50%; AND</p> <p>Patient must have relapsed or progressed following frontline therapy; or</p> <p>Patient must have failed to respond to frontline therapy; AND</p> <p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND</p> <p>Patient must have been aged between 12 months to 18 years at diagnosis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paediatric high grade glioma</p><br/><p>Initial treatment</p><br/><p>The condition must be World Health Organisation (WHO) grade 3 or 4; AND</p> <p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>Patient must have either a: (i) Karnofsky, (ii) Lansky performance score of at least 50%; AND</p> <p>Patient must have relapsed or progressed following frontline therapy; or</p> <p>Patient must have failed to respond to frontline therapy; AND</p> <p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND</p> <p>Patient must have been aged between 12 months to 18 years at diagnosis.</p> <p align=""justify"">A review and validation of the Karnofsky performance status scale can be found as a free access article here:</p><p align=""justify"">Mor, V., Laliberte, L., Morris, J.N. and Wiemann, M. (1984), The Karnofsky performance status scale: An examination of its reliability and validity in a research setting. Cancer, 53: 2002-2007. https://doi.org/10.1002/1097-0142(19840501)53:9&lt;2002::AID-CNCR2820530933&gt;3.0.CO;2-W</p> <p align=""justify"">The original publication and validation of the Lansky performance status scale can be found as a free access article here:</p><p align=""justify"">Lansky, S.B., List, M.A., Lansky, L.L., Ritter-Sterr, C. and Miller, D.R. (1987), The measurement of performance in childhood cancer patients. Cancer, 60: 1651-1656. https://doi.org/10.1002/1097-0142(19871001)60:7&lt;1651::AID-CNCR2820600738&gt;3.0.CO;2-J</p>","N","N","N","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16386_16358_R","Continuing treatment","AUTHORITY_REQUIRED","16358","16386","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paediatric low grade glioma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have either: (i) stable, (ii) responding disease based on the Response Assessment in Neuro-Oncology (RANO) criteria; AND</p> <p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paediatric low grade glioma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have either: (i) stable, (ii) responding disease based on the Response Assessment in Neuro-Oncology (RANO) criteria; AND</p> <p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition.</p> <p align=""justify"">Response in the proposed restrictions is assessed using the Response Assessment for Neuro-Oncology (RANO) 2017 criteria:</p><p align=""justify"">Wen PY, Chang SM, Van den Bent MJ, Vogelbaum MA, Macdonald DR, Lee EQ. Response Assessment in Neuro-Oncology Clinical Trials. J Clin Oncol. 2017;35(21):2439-2449. doi:10.1200/JCO.2017.72.7511</p>","N","N","N","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16387_16387_R","null","RESTRICTED","16387","16387","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe dry eye syndrome</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe dry eye syndrome</p>","N","N","N","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16388_16377_R","Initial treatment","AUTHORITY_REQUIRED","16377","16388","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paediatric low grade glioma</p><br/><p>Initial treatment</p><br/><p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The condition must have progressed following surgical excision; or</p> <p>The condition must not be amenable to surgery with risk of neurological impairment following progression; AND</p> <p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>Patient must have either a: (i) Karnofsky, (ii) Lansky performance score of at least 50%; AND</p> <p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND</p> <p>Patient must have been aged between 12 months to 18 years at diagnosis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paediatric low grade glioma</p><br/><p>Initial treatment</p><br/><p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The condition must have progressed following surgical excision; or</p> <p>The condition must not be amenable to surgery with risk of neurological impairment following progression; AND</p> <p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>Patient must have either a: (i) Karnofsky, (ii) Lansky performance score of at least 50%; AND</p> <p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND</p> <p>Patient must have been aged between 12 months to 18 years at diagnosis.</p> <p align=""justify"">A review and validation of the Karnofsky performance status scale can be found as a free access article here:</p><p align=""justify"">Mor, V., Laliberte, L., Morris, J.N. and Wiemann, M. (1984), The Karnofsky performance status scale: An examination of its reliability and validity in a research setting. Cancer, 53: 2002-2007. https://doi.org/10.1002/1097-0142(19840501)53:9&lt;2002::AID-CNCR2820530933&gt;3.0.CO;2-W</p> <p align=""justify"">The original publication and validation of the Lansky performance status scale can be found as a free access article here:</p><p align=""justify"">Lansky, S.B., List, M.A., Lansky, L.L., Ritter-Sterr, C. and Miller, D.R. (1987), The measurement of performance in childhood cancer patients. Cancer, 60: 1651-1656. https://doi.org/10.1002/1097-0142(19871001)60:7&lt;1651::AID-CNCR2820600738&gt;3.0.CO;2-J</p>","N","N","N","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16390_16390_R","Initial treatment","AUTHORITY_REQUIRED","16390","16390","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intermediate-1 risk myelofibrosis</p><br/><p>Initial treatment</p><br/><p>The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report; AND</p> <p>Patient must have severe disease-related symptoms that are resistant, refractory or intolerant to available therapy; or</p> <p>Patient must have intolerance to prior treatment with a JAK inhibitor for this condition; AND</p> <p>Patient must have a haemoglobin level of less than 100 g per L prior to commencing treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.</p> <p align=""justify"">Details of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and</p><p align=""justify"">(b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intermediate-1 risk myelofibrosis</p><br/><p>Initial treatment</p><br/><p>The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report; AND</p> <p>Patient must have severe disease-related symptoms that are resistant, refractory or intolerant to available therapy; or</p> <p>Patient must have intolerance to prior treatment with a JAK inhibitor for this condition; AND</p> <p>Patient must have a haemoglobin level of less than 100 g per L prior to commencing treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.</p> <p align=""justify"">Details of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and</p><p align=""justify"">(b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.</p>","N","N","N","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16393_16362_R","null","STREAMLINED","16362","16393","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stimulation of follicular development</p><br/><p>Patient must have severe LH deficiency; AND</p> <p>Patient must be receiving medical treatment as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stimulation of follicular development</p><br/><p>Patient must have severe LH deficiency; AND</p> <p>Patient must be receiving medical treatment as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule.</p>","N","N","N","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16394_16375_R","null","STREAMLINED","16375","16394","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced or metastatic gastro-oesophageal cancer</p><br/><p>Patient must be untreated (up until initiating this drug) with programmed cell death-1/ligand-1 (PD-1/PD-L1) inhibitor therapy for gastro-oesophageal cancer; AND</p> <p>Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND</p> <p>Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word ''cancelled'' where this occurs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced or metastatic gastro-oesophageal cancer</p><br/><p>Patient must be untreated (up until initiating this drug) with programmed cell death-1/ligand-1 (PD-1/PD-L1) inhibitor therapy for gastro-oesophageal cancer; AND</p> <p>Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND</p> <p>Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word ''cancelled'' where this occurs.</p>","N","N","N","IMMEDIATE","ALL","N","2025-04-01","N","4708"
"16395_16396_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16396","16395","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-04-01","Y","4708"
"16401_16443_R","null","STREAMLINED","16443","16401","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute coronary syndrome (myocardial infarction or unstable angina)</p><br/><p>The treatment must be in combination with aspirin; AND</p> <p>Patient must have percutaneous coronary intervention planned; or</p> <p>Patient must have previously undergone percutaneous coronary intervention; AND</p> <p>Patient must not have a known history of either: (i) stroke, (ii) transient ischaemic attack; AND</p> <p>The treatment must be ceased if a percutaneous coronary intervention is not performed; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patient must be treated with the recommended maintenance dose of prasugrel according to the TGA-approved Product Information.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute coronary syndrome (myocardial infarction or unstable angina)</p><br/><p>The treatment must be in combination with aspirin; AND</p> <p>Patient must have percutaneous coronary intervention planned; or</p> <p>Patient must have previously undergone percutaneous coronary intervention; AND</p> <p>Patient must not have a known history of either: (i) stroke, (ii) transient ischaemic attack; AND</p> <p>The treatment must be ceased if a percutaneous coronary intervention is not performed; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patient must be treated with the recommended maintenance dose of prasugrel according to the TGA-approved Product Information.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16402_16402_R","Continuing treatment","AUTHORITY_REQUIRED","16402","16402","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB/ IIIC (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB/ IIIC (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16403_16404_R","Initial treatment","AUTHORITY_REQUIRED","16404","16403","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); or</p> <p>Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material; AND</p> <p>Patient must not have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); or</p> <p>Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material; AND</p> <p>Patient must not have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16406_16433_R","Continuing treatment of combination therapy (triple therapy with selexipag)","AUTHORITY_REQUIRED","16433","16406","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment of combination therapy (triple therapy with selexipag)</p><br/><p>The treatment must be part of triple combination therapy consisting of: (i) macitentan, (ii) tadalafil, (iii) selexipag; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must be undergoing continuing treatment of existing PBS-subsidised macitentan and tadalafil as part of combination therapy (triple therapy with selexipag) where macitentan and tadalafil and their doses in the combination remain unchanged from the previous authority application.</p> <p align=""justify"">This treatment is not PBS-subsidised for the use as initial therapy</p> <p align=""justify"">The authority application for selexipag must be approved prior to the authority application for this agent.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment of combination therapy (triple therapy with selexipag)</p><br/><p>The treatment must be part of triple combination therapy consisting of: (i) macitentan, (ii) tadalafil, (iii) selexipag; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must be undergoing continuing treatment of existing PBS-subsidised macitentan and tadalafil as part of combination therapy (triple therapy with selexipag) where macitentan and tadalafil and their doses in the combination remain unchanged from the previous authority application.</p> <p align=""justify"">This treatment is not PBS-subsidised for the use as initial therapy</p> <p align=""justify"">The authority application for selexipag must be approved prior to the authority application for this agent.</p> <p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16407_16446_R","Initial treatment","AUTHORITY_REQUIRED","16446","16407","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary transthyretin amyloidosis</p><br/><p>Initial treatment</p><br/><p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>The condition must be hereditary transthyretin amyloidosis confirmed by genetic testing; AND</p> <p>Patient must have a Polyneuropathy Disability (PND) score description of either I, II, IIIA, IIIB; or</p> <p>Patient must have a Familial Amyloid Polyneuropathy (FAP) stage description of 1 or 2; AND</p> <p>Patient must not have previously undergone a liver transplant; AND</p> <p>Patient must not exhibit heart failure symptoms (defined as New York Heart Association NYHA class III or IV); AND</p> <p>Must be treated by a consultant with experience in the management of amyloid disorders or in consultation with a consultant with experience in the management of amyloid disorders; AND</p> <p>Patient must be undergoing treatment with this drug as a monotherapy (i.e. not in combination with any other disease modifying medicines for amyloidosis disorders); AND</p> <p>Patient must have either: (i) stage 1 polyneuropathy, (ii) stage 2 polyneuropathy; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">PND scores in the context of this PBS restriction are:</p><p align=""justify"">Stage 0 - No symptoms;</p><p align=""justify"">Stage I - Sensory disturbances but preserved walking capability;</p><p align=""justify"">Stage II - Impaired walking capacity but able to walk without stick or crutches;</p><p align=""justify"">Stage IIIA - Walking with help of one stick or crutch;</p><p align=""justify"">Stage IIIB - Walking with help of two sticks or crutches;</p><p align=""justify"">Stage IV - Confined to wheelchair or bedridden.</p> <p align=""justify"">FAP stage in the context of this PBS restriction are:</p><p align=""justify"">Stage 0 - No symptoms;</p><p align=""justify"">Stage 1 - Unimpaired ambulation;</p><p align=""justify"">Stage 2 - Assistance with ambulation required;</p><p align=""justify"">Stage 3 - Wheelchair-bound or bedridden.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary transthyretin amyloidosis</p><br/><p>Initial treatment</p><br/><p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>The condition must be hereditary transthyretin amyloidosis confirmed by genetic testing; AND</p> <p>Patient must have a Polyneuropathy Disability (PND) score description of either I, II, IIIA, IIIB; or</p> <p>Patient must have a Familial Amyloid Polyneuropathy (FAP) stage description of 1 or 2; AND</p> <p>Patient must not have previously undergone a liver transplant; AND</p> <p>Patient must not exhibit heart failure symptoms (defined as New York Heart Association NYHA class III or IV); AND</p> <p>Must be treated by a consultant with experience in the management of amyloid disorders or in consultation with a consultant with experience in the management of amyloid disorders; AND</p> <p>Patient must be undergoing treatment with this drug as a monotherapy (i.e. not in combination with any other disease modifying medicines for amyloidosis disorders); AND</p> <p>Patient must have either: (i) stage 1 polyneuropathy, (ii) stage 2 polyneuropathy; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">PND scores in the context of this PBS restriction are:</p><p align=""justify"">Stage 0 - No symptoms;</p><p align=""justify"">Stage I - Sensory disturbances but preserved walking capability;</p><p align=""justify"">Stage II - Impaired walking capacity but able to walk without stick or crutches;</p><p align=""justify"">Stage IIIA - Walking with help of one stick or crutch;</p><p align=""justify"">Stage IIIB - Walking with help of two sticks or crutches;</p><p align=""justify"">Stage IV - Confined to wheelchair or bedridden.</p> <p align=""justify"">FAP stage in the context of this PBS restriction are:</p><p align=""justify"">Stage 0 - No symptoms;</p><p align=""justify"">Stage 1 - Unimpaired ambulation;</p><p align=""justify"">Stage 2 - Assistance with ambulation required;</p><p align=""justify"">Stage 3 - Wheelchair-bound or bedridden.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-05-01","Y","4708"
"16410_6257_R","null","RESTRICTED","6257","16410","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anovulatory infertility</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anovulatory infertility</p> <p align=""justify"">Women who have had apparent ovulation induced by other agents and have failed to conceive should have laparoscopic evidence that there is no other impediment to conception. </p> <p>Oligomenorrhoea should have been present for at least twelve months or amenorrhoea for at least six months prior to treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16411_6321_R","null","RESTRICTED","6321","16411","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infertility</p><br/><p>The condition must be due to hypogonadotrophic hypogonadism; AND</p> <p>The treatment must be following failure of 6 months'' treatment with human chorionic gonadotrophin to achieve adequate spermatogenesis; AND</p> <p>The treatment must be administered with human chorionic gonadotrophin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infertility</p><br/><p>The condition must be due to hypogonadotrophic hypogonadism; AND</p> <p>The treatment must be following failure of 6 months'' treatment with human chorionic gonadotrophin to achieve adequate spermatogenesis; AND</p> <p>The treatment must be administered with human chorionic gonadotrophin.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16417_16419_R","Non-induction treatment","AUTHORITY_REQUIRED","16419","16417","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment resistant major depression</p><br/><p>Non-induction treatment</p><br/><p>The treatment must be to continue existing PBS-subsidised treatment for this indication; AND</p> <p>The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND</p> <p>Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient''s medical records); AND</p> <p>Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND</p> <p>Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.</p> <p align=""justify"">The listed quantity of 12 units of nasal spray is intended for a dosage of 84 mg per treatment administration in the non-induction treatment setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment resistant major depression</p><br/><p>Non-induction treatment</p><br/><p>The treatment must be to continue existing PBS-subsidised treatment for this indication; AND</p> <p>The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND</p> <p>Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient''s medical records); AND</p> <p>Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND</p> <p>Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.</p> <p align=""justify"">The listed quantity of 12 units of nasal spray is intended for a dosage of 84 mg per treatment administration in the non-induction treatment setting.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16420_16422_R","Induction treatment","AUTHORITY_REQUIRED","16422","16420","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment resistant major depression</p><br/><p>Induction treatment</p><br/><p>The condition must have been inadequately responsive to at least two oral anti-depressant drug therapies; AND</p> <p>Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND</p> <p>Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.</p> <p align=""justify"">The following must apply if reinitiating treatment:</p><p align=""justify"">(i) at least four-week gap from last treatment course to reinitiation of treatment; and</p><p align=""justify"">(ii) evidence, documented in the patient&apos;s medical record using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine; and</p><p align=""justify"">(iii) evidence, documented in the patient&apos;s medical record using a structured rating scale, of a relapse in depression.</p> <p align=""justify"">The listed quantity of 16 units of nasal spray is intended for a dosage of 56 mg per treatment administration in the induction treatment setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment resistant major depression</p><br/><p>Induction treatment</p><br/><p>The condition must have been inadequately responsive to at least two oral anti-depressant drug therapies; AND</p> <p>Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND</p> <p>Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.</p> <p align=""justify"">The following must apply if reinitiating treatment:</p><p align=""justify"">(i) at least four-week gap from last treatment course to reinitiation of treatment; and</p><p align=""justify"">(ii) evidence, documented in the patient&apos;s medical record using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine; and</p><p align=""justify"">(iii) evidence, documented in the patient&apos;s medical record using a structured rating scale, of a relapse in depression.</p> <p align=""justify"">The listed quantity of 16 units of nasal spray is intended for a dosage of 56 mg per treatment administration in the induction treatment setting.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16423_16454_R","Induction treatment","AUTHORITY_REQUIRED","16454","16423","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment resistant major depression</p><br/><p>Induction treatment</p><br/><p>The condition must have been inadequately responsive to at least two oral anti-depressant drug therapies; AND</p> <p>Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND</p> <p>Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.</p> <p align=""justify"">The following must apply if reinitiating treatment:</p><p align=""justify"">(i) at least four-week gap from last treatment course to reinitiation of treatment; and</p><p align=""justify"">(ii) evidence, documented in the patient&apos;s medical record using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine; and</p><p align=""justify"">(iii) evidence, documented in the patient&apos;s medical record using a structured rating scale, of a relapse in depression.</p> <p align=""justify"">The listed quantity of 24 units of nasal spray is intended for a dosage of 84 mg per treatment administration in the induction treatment setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment resistant major depression</p><br/><p>Induction treatment</p><br/><p>The condition must have been inadequately responsive to at least two oral anti-depressant drug therapies; AND</p> <p>Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND</p> <p>Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.</p> <p align=""justify"">The following must apply if reinitiating treatment:</p><p align=""justify"">(i) at least four-week gap from last treatment course to reinitiation of treatment; and</p><p align=""justify"">(ii) evidence, documented in the patient&apos;s medical record using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine; and</p><p align=""justify"">(iii) evidence, documented in the patient&apos;s medical record using a structured rating scale, of a relapse in depression.</p> <p align=""justify"">The listed quantity of 24 units of nasal spray is intended for a dosage of 84 mg per treatment administration in the induction treatment setting.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16424_16455_R","First line treatment","AUTHORITY_REQUIRED","16455","16424","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe aplastic anaemia</p><br/><p>First line treatment</p><br/><p>The condition must be severe aplastic anaemia; AND</p> <p>Patient must not have received treatment with immunosuppressive therapy for this condition; AND</p> <p>The treatment must be administered in combination with standard immunosuppressive therapy, including anti-thymocyte antibody and ciclosporin; AND</p> <p>Patient must be considered ineligible for haemopoietic stem cell transplant; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction in a lifetime.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe aplastic anaemia</p><br/><p>First line treatment</p><br/><p>The condition must be severe aplastic anaemia; AND</p> <p>Patient must not have received treatment with immunosuppressive therapy for this condition; AND</p> <p>The treatment must be administered in combination with standard immunosuppressive therapy, including anti-thymocyte antibody and ciclosporin; AND</p> <p>Patient must be considered ineligible for haemopoietic stem cell transplant; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction in a lifetime.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16431_16464_R","null","RESTRICTED","16464","16431","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p><br/><p>The condition must be resistant to lower potency topical corticosteroid therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p><br/><p>The condition must be resistant to lower potency topical corticosteroid therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16432_16466_R","Continuing treatment","STREAMLINED","16466","16432","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be discontinued in patients who experience disease progression whilst on treatment; AND</p> <p>Patient must be undergoing treatment with this drug administered weekly in cycles 1 to 3 - prescribe up to 9 repeats; or</p> <p>Patient must be undergoing treatment with this drug administered fortnightly in cycles 4 to 9 - prescribe up to 5 repeats; or</p> <p>Patient must be undergoing treatment with this drug administered every four weeks in cycles 10 and beyond - prescribe up to 2 repeats.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be discontinued in patients who experience disease progression whilst on treatment; AND</p> <p>Patient must be undergoing treatment with this drug administered weekly in cycles 1 to 3 - prescribe up to 9 repeats; or</p> <p>Patient must be undergoing treatment with this drug administered fortnightly in cycles 4 to 9 - prescribe up to 5 repeats; or</p> <p>Patient must be undergoing treatment with this drug administered every four weeks in cycles 10 and beyond - prescribe up to 2 repeats.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16440_16470_R","Non-induction treatment","AUTHORITY_REQUIRED","16470","16440","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment resistant major depression</p><br/><p>Non-induction treatment</p><br/><p>The treatment must be to continue existing PBS-subsidised treatment for this indication; AND</p> <p>The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND</p> <p>Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient''s medical records); AND</p> <p>Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND</p> <p>Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.</p> <p align=""justify"">The listed quantity of 8 units of nasal spray is intended for a dosage of 56 mg per treatment administration in the non-induction treatment setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment resistant major depression</p><br/><p>Non-induction treatment</p><br/><p>The treatment must be to continue existing PBS-subsidised treatment for this indication; AND</p> <p>The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND</p> <p>Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient''s medical records); AND</p> <p>Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND</p> <p>Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.</p> <p align=""justify"">The listed quantity of 8 units of nasal spray is intended for a dosage of 56 mg per treatment administration in the non-induction treatment setting.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16445_16465_R","Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements","AUTHORITY_REQUIRED","16465","16445","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS condition prior to 1 May 2025; AND</p> <p>The condition must have relapsed, or be refractory to, at least two prior systemic therapies, prior to commencing treatment with this drug; AND</p> <p>Patient must have had a WHO performance status of no higher than 2 prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must have previously received treatment with chimeric antigen receptor-T (CAR-T) cell therapy for this condition; or</p> <p>Patient must have been unable to receive treatment with CAR-T cell therapy for this condition; AND</p> <p>Patient must not be eligible for stem cell transplantation; AND</p> <p>The treatment must be discontinued in patients who experience disease progression whilst on treatment; AND</p> <p>Patient must be undergoing treatment with this drug administered weekly in cycles 1 to 3 - prescribe up to 9 repeats; or</p> <p>Patient must be undergoing treatment with this drug administered fortnightly in cycles 4 to 9 - prescribe up to 5 repeats; or</p> <p>Patient must be undergoing treatment with this drug administered every four weeks in cycles 10 and beyond - prescribe up to 2 repeats.</p> <p align=""justify"">Prior systemic therapy may include autologous stem cell transplant.</p> <p align=""justify"">Definition of patients unable to receive treatment with CAR-T cell therapy for this condition include geographical, psychosocial, clinical ineligibility or urgency.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS condition prior to 1 May 2025; AND</p> <p>The condition must have relapsed, or be refractory to, at least two prior systemic therapies, prior to commencing treatment with this drug; AND</p> <p>Patient must have had a WHO performance status of no higher than 2 prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must have previously received treatment with chimeric antigen receptor-T (CAR-T) cell therapy for this condition; or</p> <p>Patient must have been unable to receive treatment with CAR-T cell therapy for this condition; AND</p> <p>Patient must not be eligible for stem cell transplantation; AND</p> <p>The treatment must be discontinued in patients who experience disease progression whilst on treatment; AND</p> <p>Patient must be undergoing treatment with this drug administered weekly in cycles 1 to 3 - prescribe up to 9 repeats; or</p> <p>Patient must be undergoing treatment with this drug administered fortnightly in cycles 4 to 9 - prescribe up to 5 repeats; or</p> <p>Patient must be undergoing treatment with this drug administered every four weeks in cycles 10 and beyond - prescribe up to 2 repeats.</p> <p align=""justify"">Prior systemic therapy may include autologous stem cell transplant.</p> <p align=""justify"">Definition of patients unable to receive treatment with CAR-T cell therapy for this condition include geographical, psychosocial, clinical ineligibility or urgency.</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16447_16434_R","Continuing treatment","AUTHORITY_REQUIRED","16434","16447","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary transthyretin amyloidosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must continue to demonstrate clinical benefit; AND</p> <p>Patient must not have previously undergone a liver transplant; AND</p> <p>Patient must not be permanently bedridden; or</p> <p>Patient must not be receiving end-of-life care; AND</p> <p>Must be treated by a consultant with experience in the management of amyloid disorders or in consultation with a consultant with experience in the management of amyloid disorders; AND</p> <p>Patient must be undergoing treatment with this drug as a monotherapy (i.e. not in combination with any other disease modifying medicines for amyloidosis disorders).</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary transthyretin amyloidosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must continue to demonstrate clinical benefit; AND</p> <p>Patient must not have previously undergone a liver transplant; AND</p> <p>Patient must not be permanently bedridden; or</p> <p>Patient must not be receiving end-of-life care; AND</p> <p>Must be treated by a consultant with experience in the management of amyloid disorders or in consultation with a consultant with experience in the management of amyloid disorders; AND</p> <p>Patient must be undergoing treatment with this drug as a monotherapy (i.e. not in combination with any other disease modifying medicines for amyloidosis disorders).</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-05-01","Y","4708"
"16452_16414_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16414","16452","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-05-01","Y","4708"
"16453_16460_R","Non-induction treatment","AUTHORITY_REQUIRED","16460","16453","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment resistant major depression</p><br/><p>Non-induction treatment</p><br/><p>The treatment must be to continue existing PBS-subsidised treatment for this indication; AND</p> <p>The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND</p> <p>Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient''s medical records); AND</p> <p>Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND</p> <p>Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.</p> <p align=""justify"">The listed quantity of 4 units of nasal spray is intended for a dosage of 28 mg per treatment administration in the non-induction treatment setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment resistant major depression</p><br/><p>Non-induction treatment</p><br/><p>The treatment must be to continue existing PBS-subsidised treatment for this indication; AND</p> <p>The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND</p> <p>Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient''s medical records); AND</p> <p>Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND</p> <p>Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.</p> <p align=""justify"">The listed quantity of 4 units of nasal spray is intended for a dosage of 28 mg per treatment administration in the non-induction treatment setting.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16456_16456_R","null","STREAMLINED","16456","16456","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Patient must have previously received and be stabilised on PBS-subsidised aripiprazole once-monthly injection.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Patient must have previously received and be stabilised on PBS-subsidised aripiprazole once-monthly injection.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16461_16477_R","Induction treatment","AUTHORITY_REQUIRED","16477","16461","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment resistant major depression</p><br/><p>Induction treatment</p><br/><p>The condition must have been inadequately responsive to at least two oral anti-depressant drug therapies; AND</p> <p>Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND</p> <p>Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.</p> <p align=""justify"">The following must apply if reinitiating treatment:</p><p align=""justify"">(i) at least four-week gap from last treatment course to reinitiation of treatment; and</p><p align=""justify"">(ii) evidence, documented in the patient&apos;s medical record using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine; and</p><p align=""justify"">(iii) evidence, documented in the patient&apos;s medical record using a structured rating scale, of a relapse in depression.</p> <p align=""justify"">The listed quantity of 8 units of nasal spray is intended for a dosage of 28 mg per treatment administration in the induction treatment setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment resistant major depression</p><br/><p>Induction treatment</p><br/><p>The condition must have been inadequately responsive to at least two oral anti-depressant drug therapies; AND</p> <p>Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND</p> <p>Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine.</p> <p align=""justify"">The following must apply if reinitiating treatment:</p><p align=""justify"">(i) at least four-week gap from last treatment course to reinitiation of treatment; and</p><p align=""justify"">(ii) evidence, documented in the patient&apos;s medical record using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine; and</p><p align=""justify"">(iii) evidence, documented in the patient&apos;s medical record using a structured rating scale, of a relapse in depression.</p> <p align=""justify"">The listed quantity of 8 units of nasal spray is intended for a dosage of 28 mg per treatment administration in the induction treatment setting.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16468_16457_R","Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)","AUTHORITY_REQUIRED","16457","16468","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)</p><br/><p>The treatment must be dual combination therapy as a fixed dose combination consisting of: (i) macitentan, (ii) tadalafil; or</p> <p>The treatment must be part of triple combination therapy as a fixed dose combination consisting of: (i) macitentan, (ii) tadalafil, (iii) one prostanoid; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must be undergoing continuing treatment of existing PBS-subsidised macitentan and tadalafil as part of combination therapy (dual or triple therapy, excluding selexipag) where macitentan and tadalafil and their doses in the combination remain unchanged from the previous authority application.</p> <p align=""justify"">This treatment is not PBS-subsidised for the use as initial therapy</p> <p align=""justify"">For the purposes of PBS subsidy, a prostanoid is one of: (a) epoprostenol, (b) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination&apos; therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)</p><br/><p>The treatment must be dual combination therapy as a fixed dose combination consisting of: (i) macitentan, (ii) tadalafil; or</p> <p>The treatment must be part of triple combination therapy as a fixed dose combination consisting of: (i) macitentan, (ii) tadalafil, (iii) one prostanoid; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must be undergoing continuing treatment of existing PBS-subsidised macitentan and tadalafil as part of combination therapy (dual or triple therapy, excluding selexipag) where macitentan and tadalafil and their doses in the combination remain unchanged from the previous authority application.</p> <p align=""justify"">This treatment is not PBS-subsidised for the use as initial therapy</p> <p align=""justify"">For the purposes of PBS subsidy, a prostanoid is one of: (a) epoprostenol, (b) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination&apos; therapy.</p> <p align=""justify"">If this authority application is to continue combination therapy, but with a change in prostanoid, the &apos;Initial 3 - change&apos; treatment phase restriction of the new drug outlines the continuing eligibility criteria of that new drug.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16471_16425_R","Subsequent continuing treatment - Maintenance treatment","AUTHORITY_REQUIRED","16425","16471","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic obstructive hypertrophic cardiomyopathy</p><br/><p>Subsequent continuing treatment - Maintenance treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must be undergoing concomitant treatment with at least one of: (i) a beta-blocker (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy; AND</p> <p>Patient must have a current left ventricular ejection fraction (LVEF) of no less than 50%; AND</p> <p>Patient must have demonstrated a response after at least 6 months on the optimal dose of mavacamten treatment defined as an improvement in at least one of the following: (i) symptoms, (ii) quality of life, (iii) exercise capacity, (iv) peak left ventricular outflow tract (LVOT) gradient; AND</p> <p>Must be treated by a cardiologist; or</p> <p>Must be treated by a consultant physician with experience in the management of hypertrophic cardiomyopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic obstructive hypertrophic cardiomyopathy</p><br/><p>Subsequent continuing treatment - Maintenance treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must be undergoing concomitant treatment with at least one of: (i) a beta-blocker (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy; AND</p> <p>Patient must have a current left ventricular ejection fraction (LVEF) of no less than 50%; AND</p> <p>Patient must have demonstrated a response after at least 6 months on the optimal dose of mavacamten treatment defined as an improvement in at least one of the following: (i) symptoms, (ii) quality of life, (iii) exercise capacity, (iv) peak left ventricular outflow tract (LVOT) gradient; AND</p> <p>Must be treated by a cardiologist; or</p> <p>Must be treated by a consultant physician with experience in the management of hypertrophic cardiomyopathy.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16472_16472_R","Initial treatment","AUTHORITY_REQUIRED","16472","16472","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB/ IIIC (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation; AND</p> <p>Patient must have/have had a WHO performance status of no greater than 2 at treatment initiation with this drug for this condition; AND</p> <p>Patient must not have previously received this drug for this condition; or</p> <p>Patient must be each of: (i) currently receiving non-PBS-subsidised supply for this drug for this PBS indication, (ii) free of disease progression since commencing non-PBS-subsidised supply; AND</p> <p>The treatment must be/have been in combination with platinum-based chemotherapy (PBC) where the patient has not previously received systemic therapy for this condition in the metastatic setting, (i.e. used in combination with PBC in the first line setting); or</p> <p>The treatment must be the sole PBS-subsidised therapy where the condition has progressed following treatment with platinum-based chemotherapy, (i.e. used as monotherapy in the second line setting).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB/ IIIC (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation; AND</p> <p>Patient must have/have had a WHO performance status of no greater than 2 at treatment initiation with this drug for this condition; AND</p> <p>Patient must not have previously received this drug for this condition; or</p> <p>Patient must be each of: (i) currently receiving non-PBS-subsidised supply for this drug for this PBS indication, (ii) free of disease progression since commencing non-PBS-subsidised supply; AND</p> <p>The treatment must be/have been in combination with platinum-based chemotherapy (PBC) where the patient has not previously received systemic therapy for this condition in the metastatic setting, (i.e. used in combination with PBC in the first line setting); or</p> <p>The treatment must be the sole PBS-subsidised therapy where the condition has progressed following treatment with platinum-based chemotherapy, (i.e. used as monotherapy in the second line setting).</p> <p align=""justify"">A patient may only qualify for PBS-subsidised treatment under this restriction once.</p><p align=""justify"">Following completion of the initial PBS-subsidised course, further applications for treatment will be assessed under the continuing treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16478_16482_R","Initial treatment","AUTHORITY_REQUIRED","16482","16478","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to age-related macular degeneration (AMD); AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to age-related macular degeneration (AMD); AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-05-01","Y","4708"
"16479_16479_R","Continuing treatment","AUTHORITY_REQUIRED","16479","16479","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Amyotrophic lateral sclerosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have undergone a tracheostomy; AND</p> <p>Patient must not have experienced respiratory failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Amyotrophic lateral sclerosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have undergone a tracheostomy; AND</p> <p>Patient must not have experienced respiratory failure.</p>","N","N","N","IMMEDIATE","ALL","N","2025-05-01","N","4708"
"16484_16551_R","null","STREAMLINED","16551","16484","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ulcerative colitis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have had a documented hypersensitivity reaction to a sulphonamide; or</p> <p>Patient must be intolerant to sulfasalazine; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ulcerative colitis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have had a documented hypersensitivity reaction to a sulphonamide; or</p> <p>Patient must be intolerant to sulfasalazine; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16485_16491_R","null","RESTRICTED","16491","16485","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ulcerative colitis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ulcerative colitis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16486_16603_R","null","RESTRICTED","16603","16486","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Crohn disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Crohn disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16487_16552_R","null","RESTRICTED","16552","16487","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ulcerative colitis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ulcerative colitis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16488_16634_R","null","AUTHORITY_REQUIRED","16634","16488","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Scleroderma oesophagus</p><br/><p>Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Scleroderma oesophagus</p><br/><p>Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16492_16493_R","null","RESTRICTED","16493","16492","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16494_15288_R","null","STREAMLINED","15288","16494","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately responsive to metformin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately responsive to metformin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16495_15261_R","null","STREAMLINED","15261","16495","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16496_15276_R","null","STREAMLINED","15276","16496","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be inadequately responsive to metformin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be inadequately responsive to metformin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16497_15287_R","null","STREAMLINED","15287","16497","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be used in combination with at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>The condition must be inadequately responsive to at least one of: metformin, a sulfonylurea, insulin; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another DPP4 inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16498_16499_R","null","RESTRICTED","16499","16498","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phaeochromocytoma</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phaeochromocytoma</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16500_5324_R","null","RESTRICTED","5324","16500","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe heart failure</p><br/><p>Patient must be stabilised on conventional therapy, which must include an ACE inhibitor or Angiotensin II antagonist, if tolerated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe heart failure</p><br/><p>Patient must be stabilised on conventional therapy, which must include an ACE inhibitor or Angiotensin II antagonist, if tolerated.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16501_14251_R","null","RESTRICTED","14251","16501","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe heart failure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be stabilised on conventional therapy, which must include an ACE inhibitor or Angiotensin II antagonist, if tolerated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe heart failure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be stabilised on conventional therapy, which must include an ACE inhibitor or Angiotensin II antagonist, if tolerated.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16502_6809_R","null","RESTRICTED","6809","16502","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic stable plaque type psoriasis vulgaris</p><br/><p>The condition must be inadequately controlled by potent topical corticosteroid monotherapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic stable plaque type psoriasis vulgaris</p><br/><p>The condition must be inadequately controlled by potent topical corticosteroid monotherapy.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16503_14236_R","null","RESTRICTED","14236","16503","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic stable plaque type psoriasis vulgaris</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately controlled by potent topical corticosteroid monotherapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic stable plaque type psoriasis vulgaris</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately controlled by potent topical corticosteroid monotherapy.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16504_4957_R","null","RESTRICTED","4957","16504","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16505_6218_R","null","STREAMLINED","6218","16505","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p><br/><p>The condition must cover 40-60% of the patient''s body surface area.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p><br/><p>The condition must cover 40-60% of the patient''s body surface area.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16506_6231_R","null","STREAMLINED","6231","16506","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p><br/><p>The condition must cover >80% of the patient''s body surface area.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p><br/><p>The condition must cover >80% of the patient''s body surface area.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16507_15004_R","null","STREAMLINED","15004","16507","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have lower urinary tract symptoms; AND</p> <p>Patient must have moderate to severe benign prostatic hyperplasia.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have lower urinary tract symptoms; AND</p> <p>Patient must have moderate to severe benign prostatic hyperplasia.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16509_16607_R","null","STREAMLINED","16607","16509","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Thyroid cancer</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Thyroid cancer</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16511_16512_R","null","STREAMLINED","16512","16511","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to castration-resistant prostate cancer; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to castration-resistant prostate cancer; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16513_5141_R","null","RESTRICTED","5141","16513","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16516_16517_R","null","AUTHORITY_REQUIRED","16517","16516","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epilepsy</p><br/><p>The condition must be neurologically proven; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epilepsy</p><br/><p>The condition must be neurologically proven; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16522_14847_R","Continuing treatment","STREAMLINED","14847","16522","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be aged 12 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be aged 12 years or older.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16524_16524_R","null","RESTRICTED","16524","16524","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For prescribing by certain health practitioners</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For prescribing by certain health practitioners</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16530_16690_R","null","RESTRICTED","16690","16530","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Patient must be experiencing fluctuations in motor function due to end-of-dose effect; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Patient must be experiencing fluctuations in motor function due to end-of-dose effect; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16531_16591_R","null","RESTRICTED","16591","16531","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must be stabilised on concomitant treatment with levodopa decarboxylase inhibitor combinations and entacapone; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must be stabilised on concomitant treatment with levodopa decarboxylase inhibitor combinations and entacapone; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16532_16592_R","null","RESTRICTED","16592","16532","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must be being treated with levodopa decarboxylase inhibitor combinations; AND</p> <p>Patient must be experiencing fluctuations in motor function due to end-of-dose effect; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must be being treated with levodopa decarboxylase inhibitor combinations; AND</p> <p>Patient must be experiencing fluctuations in motor function due to end-of-dose effect; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16535_16536_R","null","RESTRICTED","16536","16535","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16539_16540_R","null","RESTRICTED","16540","16539","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16542_15553_R","null","RESTRICTED","15553","16542","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depressive disorders</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depressive disorders</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16543_5650_R","null","RESTRICTED","5650","16543","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depressive disorders</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depressive disorders</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16544_16597_R","null","AUTHORITY_REQUIRED","16597","16544","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Patient must require continuous coverage over 12 hours; AND</p> <p>The treatment must not exceed a maximum daily dose of 70 mg of PBS-subsidised treatment with this drug; AND</p> <p>Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive; or</p> <p>Patient must have had a diagnosis of ADHD prior to turning 18 years of age if PBS-subsidised treatment is continuing beyond 18 years of age; or</p> <p>Patient must have a retrospective diagnosis of ADHD if PBS-subsidised treatment is commencing after turning 18 years of age; or</p> <p>Patient must have had a retrospective diagnosis of ADHD if PBS-subsidised treatment is continuing in a patient who commenced PBS-subsidised treatment after turning 18 years of age; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p> <p align=""justify"">A retrospective diagnosis of ADHD for the purposes of administering this restriction is:</p><p align=""justify"">(i) the presence of pre-existing childhood symptoms of ADHD (onset during the developmental period, typically early to mid-childhood); and</p><p align=""justify"">(ii) documentation in the patient&apos;s medical records that an in-depth clinical interview with, or, obtainment of evidence from, either a: (a) parent, (b) teacher, (c) sibling, (d) third party<b>,</b> has occurred and which supports point (i) above.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Patient must require continuous coverage over 12 hours; AND</p> <p>The treatment must not exceed a maximum daily dose of 70 mg of PBS-subsidised treatment with this drug; AND</p> <p>Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive; or</p> <p>Patient must have had a diagnosis of ADHD prior to turning 18 years of age if PBS-subsidised treatment is continuing beyond 18 years of age; or</p> <p>Patient must have a retrospective diagnosis of ADHD if PBS-subsidised treatment is commencing after turning 18 years of age; or</p> <p>Patient must have had a retrospective diagnosis of ADHD if PBS-subsidised treatment is continuing in a patient who commenced PBS-subsidised treatment after turning 18 years of age; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p> <p align=""justify"">A retrospective diagnosis of ADHD for the purposes of administering this restriction is:</p><p align=""justify"">(i) the presence of pre-existing childhood symptoms of ADHD (onset during the developmental period, typically early to mid-childhood); and</p><p align=""justify"">(ii) documentation in the patient&apos;s medical records that an in-depth clinical interview with, or, obtainment of evidence from, either a: (a) parent, (b) teacher, (c) sibling, (d) third party<b>,</b> has occurred and which supports point (i) above.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16546_16545_R","null","AUTHORITY_REQUIRED","16545","16546","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND</p> <p>Patient must require continuous coverage over 8 hours; AND</p> <p>The treatment must not exceed a maximum daily dose of 80 mg of PBS-subsidised treatment with this drug; AND</p> <p>Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive; or</p> <p>Patient must have had a diagnosis of ADHD prior to turning 18 years of age if PBS-subsidised treatment is continuing beyond 18 years of age; or</p> <p>Patient must have a retrospective diagnosis of ADHD if PBS-subsidised treatment is commencing after turning 18 years of age; or</p> <p>Patient must have had a retrospective diagnosis of ADHD if PBS-subsidised treatment is continuing in a patient who commenced PBS-subsidised treatment after turning 18 years of age; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p> <p align=""justify"">A retrospective diagnosis of ADHD for the purposes of administering this restriction is:</p><p align=""justify"">(i) the presence of pre-existing childhood symptoms of ADHD (onset during the developmental period, typically early to mid-childhood); and</p><p align=""justify"">(ii) documentation in the patient&apos;s medical records that an in-depth clinical interview with, or, obtainment of evidence from, either a: (a) parent, (b) teacher, (c) sibling, (d) third party<b>,</b> has occurred and which supports point (i) above.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND</p> <p>Patient must require continuous coverage over 8 hours; AND</p> <p>The treatment must not exceed a maximum daily dose of 80 mg of PBS-subsidised treatment with this drug; AND</p> <p>Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive; or</p> <p>Patient must have had a diagnosis of ADHD prior to turning 18 years of age if PBS-subsidised treatment is continuing beyond 18 years of age; or</p> <p>Patient must have a retrospective diagnosis of ADHD if PBS-subsidised treatment is commencing after turning 18 years of age; or</p> <p>Patient must have had a retrospective diagnosis of ADHD if PBS-subsidised treatment is continuing in a patient who commenced PBS-subsidised treatment after turning 18 years of age; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p> <p align=""justify"">A retrospective diagnosis of ADHD for the purposes of administering this restriction is:</p><p align=""justify"">(i) the presence of pre-existing childhood symptoms of ADHD (onset during the developmental period, typically early to mid-childhood); and</p><p align=""justify"">(ii) documentation in the patient&apos;s medical records that an in-depth clinical interview with, or, obtainment of evidence from, either a: (a) parent, (b) teacher, (c) sibling, (d) third party<b>,</b> has occurred and which supports point (i) above.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16547_16548_R","null","RESTRICTED","16548","16547","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate ulcerative proctitis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate ulcerative proctitis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16549_16632_R","null","STREAMLINED","16632","16549","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate ulcerative colitis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate ulcerative colitis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16550_16633_R","null","RESTRICTED","16633","16550","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate ulcerative proctitis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate ulcerative proctitis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16553_16490_R","null","RESTRICTED","16490","16553","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Crohn disease</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Crohn disease</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16554_16555_R","null","AUTHORITY_REQUIRED","16555","16554","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion</p><br/><p>Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion</p><br/><p>Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16556_16695_R","null","STREAMLINED","16695","16556","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate Crohn disease</p><br/><p>The condition must affect the ileum; or</p> <p>The condition must affect the ascending colon; or</p> <p>The condition must affect the ileum and ascending colon; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p> <p align=""justify"">The total duration of therapy should be no more than 10 weeks in any single course.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate Crohn disease</p><br/><p>The condition must affect the ileum; or</p> <p>The condition must affect the ascending colon; or</p> <p>The condition must affect the ileum and ascending colon; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p> <p align=""justify"">The total duration of therapy should be no more than 10 weeks in any single course.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16557_16489_R","null","AUTHORITY_REQUIRED","16489","16557","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Scleroderma oesophagus</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Scleroderma oesophagus</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16559_16559_R","null","RESTRICTED","16559","16559","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For prescribing by certain health practitioners</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For prescribing by certain health practitioners</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16560_15270_R","null","STREAMLINED","15270","16560","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be in combination with at least metformin; AND</p> <p>The condition must be inadequately responsive to dual therapy consisting of metformin with either: a DDP-4 inhibitor, an SGLT2 inhibitor; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor, another DPP4 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be in combination with at least metformin; AND</p> <p>The condition must be inadequately responsive to dual therapy consisting of metformin with either: a DDP-4 inhibitor, an SGLT2 inhibitor; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor, another DPP4 inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16561_16562_R","Initial treatment","AUTHORITY_REQUIRED","16562","16561","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Initial treatment</p><br/><p>Must be treated by a cardiologist; or</p> <p>Must be treated by an authorised prescriber (medical practitioner, nurse practitioner) who has been directed to prescribe this medicine by a cardiologist; AND</p> <p>Patient must be symptomatic with NYHA classes II, III or IV; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than 45%; AND</p> <p>The condition must be stabilised following a decompensation event that required at least one of: (i) hospitalisation in the past 6 months, (ii) intravenous diuretic therapy in the past three months; AND</p> <p>Patient must not have clinical signs of fluid overload; AND</p> <p>Patient must not have received intravenous treatment for fluid overload in the previous 24 hours; AND</p> <p>Patient must not have a systolic blood pressure less than 100 mmHg; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Initial treatment</p><br/><p>Must be treated by a cardiologist; or</p> <p>Must be treated by an authorised prescriber (medical practitioner, nurse practitioner) who has been directed to prescribe this medicine by a cardiologist; AND</p> <p>Patient must be symptomatic with NYHA classes II, III or IV; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than 45%; AND</p> <p>The condition must be stabilised following a decompensation event that required at least one of: (i) hospitalisation in the past 6 months, (ii) intravenous diuretic therapy in the past three months; AND</p> <p>Patient must not have clinical signs of fluid overload; AND</p> <p>Patient must not have received intravenous treatment for fluid overload in the previous 24 hours; AND</p> <p>Patient must not have a systolic blood pressure less than 100 mmHg; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16563_14994_R","null","RESTRICTED","14994","16563","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe refractory hypertension</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be initiated by a consultant physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe refractory hypertension</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be initiated by a consultant physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16566_16567_R","null","RESTRICTED","16567","16566","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neurogenic urinary retention</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neurogenic urinary retention</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16568_14270_R","null","RESTRICTED","14270","16568","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16569_6232_R","null","STREAMLINED","6232","16569","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p><br/><p>The condition must cover 10-20% of the patient''s body surface area.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p><br/><p>The condition must cover 10-20% of the patient''s body surface area.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16570_6263_R","null","STREAMLINED","6263","16570","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p><br/><p>The condition must cover 60-80% of the patient''s body surface area.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p><br/><p>The condition must cover 60-80% of the patient''s body surface area.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16571_6246_R","null","STREAMLINED","6246","16571","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p><br/><p>The condition must cover 20-40% of the patient''s body surface area.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p><br/><p>The condition must cover 20-40% of the patient''s body surface area.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16572_15018_R","null","STREAMLINED","15018","16572","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have lower urinary tract symptoms; AND</p> <p>Patient must have moderate to severe benign prostatic hyperplasia; AND</p> <p>The treatment must be in combination with an alpha-antagonist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have lower urinary tract symptoms; AND</p> <p>Patient must have moderate to severe benign prostatic hyperplasia; AND</p> <p>The treatment must be in combination with an alpha-antagonist.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16573_16698_R","null","STREAMLINED","16698","16573","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Thyroid cancer</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Thyroid cancer</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16574_16508_R","null","RESTRICTED","16508","16574","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16576_16608_R","null","STREAMLINED","16608","16576","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to breast cancer; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to breast cancer; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16578_16577_R","null","RESTRICTED","16577","16578","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic Paget disease of bone</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic Paget disease of bone</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16587_14901_R","null","STREAMLINED","14901","16587","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be for prophylaxis; AND</p> <p>Patient must have experienced an average of 3 or more migraines per month over a period of at least 6 months; AND</p> <p>Patient must have a contraindication to beta-blockers, as described in the relevant TGA-approved Product Information; or</p> <p>Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with a beta-blocker; AND</p> <p>Patient must have a contraindication to pizotifen because the weight gain associated with this drug poses an unacceptable risk; or</p> <p>Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with pizotifen.</p> <p>Details of the contraindication and/or intolerance(s) must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be for prophylaxis; AND</p> <p>Patient must have experienced an average of 3 or more migraines per month over a period of at least 6 months; AND</p> <p>Patient must have a contraindication to beta-blockers, as described in the relevant TGA-approved Product Information; or</p> <p>Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with a beta-blocker; AND</p> <p>Patient must have a contraindication to pizotifen because the weight gain associated with this drug poses an unacceptable risk; or</p> <p>Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with pizotifen.</p> <p>Details of the contraindication and/or intolerance(s) must be documented in the patient&apos;s medical records when treatment is initiated.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16593_16653_R","null","AUTHORITY_REQUIRED","16653","16593","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myoclonic epilepsy</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myoclonic epilepsy</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16594_6235_R","null","RESTRICTED","6235","16594","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depression</p><br/><p>The treatment must be for use when other anti-depressant therapy has failed.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depression</p><br/><p>The treatment must be for use when other anti-depressant therapy has failed.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16595_6278_R","null","RESTRICTED","6278","16595","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe depression</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe depression</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16599_5341_R","Initial treatment","AUTHORITY_REQUIRED","5341","16599","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Amyotrophic lateral sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed by a neurologist; AND</p> <p>Patient must not have had the disease for more than 5 years; AND</p> <p>Patient must have at least 60 percent of predicted forced vital capacity within the 2 months before commencing therapy with this drug; AND</p> <p>Patient must be ambulatory; or</p> <p>Patient must not be ambulatory, and must be able to either use upper limbs or to swallow; AND</p> <p>Patient must not have undergone a tracheostomy; AND</p> <p>Patient must not have experienced respiratory failure.</p> <p align=""justify"">The date of diagnosis and the date and results of spirometry (in terms of percent of predicted forced vital capacity) must be supplied with the initial authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Amyotrophic lateral sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed by a neurologist; AND</p> <p>Patient must not have had the disease for more than 5 years; AND</p> <p>Patient must have at least 60 percent of predicted forced vital capacity within the 2 months before commencing therapy with this drug; AND</p> <p>Patient must be ambulatory; or</p> <p>Patient must not be ambulatory, and must be able to either use upper limbs or to swallow; AND</p> <p>Patient must not have undergone a tracheostomy; AND</p> <p>Patient must not have experienced respiratory failure.</p> <p align=""justify"">The date of diagnosis and the date and results of spirometry (in terms of percent of predicted forced vital capacity) must be supplied with the initial authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16601_16673_R","null","RESTRICTED","16673","16601","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proctitis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proctitis</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16602_16674_R","null","STREAMLINED","16674","16602","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate Crohn disease</p><br/><p>The condition must affect the ileum; or</p> <p>The condition must affect the ascending colon; or</p> <p>The condition must affect the ileum and ascending colon; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p> <p align=""justify"">The total duration of therapy should be no more than 12 weeks in any single course.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate Crohn disease</p><br/><p>The condition must affect the ileum; or</p> <p>The condition must affect the ascending colon; or</p> <p>The condition must affect the ileum and ascending colon; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p> <p align=""justify"">The total duration of therapy should be no more than 12 weeks in any single course.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16604_16658_R","null","STREAMLINED","16658","16604","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ulcerative colitis</p><br/><p>Patient must have had a documented hypersensitivity reaction to a sulphonamide; or</p> <p>Patient must be intolerant to sulfasalazine; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ulcerative colitis</p><br/><p>Patient must have had a documented hypersensitivity reaction to a sulphonamide; or</p> <p>Patient must be intolerant to sulfasalazine; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16605_15269_R","null","STREAMLINED","15269","16605","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The treatment must be in combination with at least metformin; AND</p> <p>The condition must be inadequately responsive to dual therapy consisting of metformin with either: a DDP-4 inhibitor, an SGLT2 inhibitor; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor, another DPP4 inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>The treatment must be in combination with at least metformin; AND</p> <p>The condition must be inadequately responsive to dual therapy consisting of metformin with either: a DDP-4 inhibitor, an SGLT2 inhibitor; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor, another DPP4 inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16606_6302_R","null","RESTRICTED","6302","16606","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eczema</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eczema</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16609_16679_R","null","RESTRICTED","16679","16609","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to breast cancer; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to breast cancer; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16610_4172_R","null","STREAMLINED","4172","16610","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neuropathic pain</p><br/><p>The condition must be refractory to treatment with other drugs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neuropathic pain</p><br/><p>The condition must be refractory to treatment with other drugs.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16611_5859_R","null","AUTHORITY_REQUIRED","5859","16611","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past; AND</p> <p>Patient must be one in whom adverse events have occurred with other suitable PBS-listed drugs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past; AND</p> <p>Patient must be one in whom adverse events have occurred with other suitable PBS-listed drugs.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16612_5849_R","null","AUTHORITY_REQUIRED","5849","16612","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past; AND</p> <p>Patient must be one in whom transfer to another suitable PBS-listed drug would cause patient confusion resulting in problems with compliance.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past; AND</p> <p>Patient must be one in whom transfer to another suitable PBS-listed drug would cause patient confusion resulting in problems with compliance.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16617_7789_R","Continuing treatment","STREAMLINED","7789","16617","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be aged 12 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be aged 12 years or older.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16622_16534_R","null","RESTRICTED","16534","16622","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be being treated with levodopa decarboxylase inhibitor combinations; AND</p> <p>Patient must be experiencing fluctuations in motor function due to end-of-dose effect; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be being treated with levodopa decarboxylase inhibitor combinations; AND</p> <p>Patient must be experiencing fluctuations in motor function due to end-of-dose effect; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16623_16688_R","null","RESTRICTED","16688","16623","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be one in which fluctuations in motor function are not adequately controlled by frequent dosing with conventional formulations of levodopa with decarboxylase inhibitor; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be one in which fluctuations in motor function are not adequately controlled by frequent dosing with conventional formulations of levodopa with decarboxylase inhibitor; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16625_16692_R","null","AUTHORITY_REQUIRED","16692","16625","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Malignant neoplasia (late stage)</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Malignant neoplasia (late stage)</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16626_5941_R","null","AUTHORITY_REQUIRED","5941","16626","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Insomnia</p><br/><p>Patient must be receiving this drug for the management of insomnia; AND</p> <p>Patient must be receiving long-term nursing care; AND</p> <p>Patient must be one in respect of whom a Carer Allowance is payable as a disabled adult; AND</p> <p>Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Insomnia</p><br/><p>Patient must be receiving this drug for the management of insomnia; AND</p> <p>Patient must be receiving long-term nursing care; AND</p> <p>Patient must be one in respect of whom a Carer Allowance is payable as a disabled adult; AND</p> <p>Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16627_16596_R","null","AUTHORITY_REQUIRED","16596","16627","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p> <p align=""justify"">Treatment must be in accordance with the law of the relevant State or Territory.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p> <p align=""justify"">Treatment must be in accordance with the law of the relevant State or Territory.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16628_16629_R","null","AUTHORITY_REQUIRED","16629","16628","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16630_16598_R","null","AUTHORITY_REQUIRED","16598","16630","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND</p> <p>Patient must require continuous coverage over 12 hours; AND</p> <p>The treatment must not exceed a maximum daily dose of 72 mg of PBS-subsidised treatment with this drug; AND</p> <p>Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND</p> <p>Patient must require continuous coverage over 12 hours; AND</p> <p>The treatment must not exceed a maximum daily dose of 72 mg of PBS-subsidised treatment with this drug; AND</p> <p>Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16631_15719_R","Continuing treatment","AUTHORITY_REQUIRED","15719","16631","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Amyotrophic lateral sclerosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be ambulatory; or</p> <p>Patient must not be ambulatory, and must be able to either use upper limbs or to swallow; AND</p> <p>Patient must not have undergone a tracheostomy; AND</p> <p>Patient must not have experienced respiratory failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Amyotrophic lateral sclerosis</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be ambulatory; or</p> <p>Patient must not be ambulatory, and must be able to either use upper limbs or to swallow; AND</p> <p>Patient must not have undergone a tracheostomy; AND</p> <p>Patient must not have experienced respiratory failure.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16635_16558_R","null","STREAMLINED","16558","16635","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary biliary cholangitis (previously known as Primary biliary cirrhosis)</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary biliary cholangitis (previously known as Primary biliary cirrhosis)</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16636_5394_R","null","RESTRICTED","5394","16636","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16637_4898_R","null","RESTRICTED","4898","16637","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne vulgaris</p><br/><p>The treatment must be maintenance therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne vulgaris</p><br/><p>The treatment must be maintenance therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16637_C","null","null","null","null","null","<p align=""justify"">The myocardial depressant effects of this drug and of beta-blocking drugs are additive.</p>","N","Y","N","null","null","N","2015-08-01","N","4708"
"16638_6475_R","null","STREAMLINED","6475","16638","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothyroidism</p><br/><p>The condition must be severe hypothyroidism; AND</p> <p>The treatment must be for initiation of therapy only.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothyroidism</p><br/><p>The condition must be severe hypothyroidism; AND</p> <p>The treatment must be for initiation of therapy only.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16638_C","null","null","null","null","null","<p align=""justify"">Serum electrolytes should be checked regularly.</p>","N","Y","N","null","null","N","2015-08-01","N","4708"
"16639_16678_R","null","AUTHORITY_REQUIRED","16678","16639","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic Paget disease of bone</p><br/><p>The treatment must be for a patient who cannot tolerate bisphosphonates due to kidney disease; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic Paget disease of bone</p><br/><p>The treatment must be for a patient who cannot tolerate bisphosphonates due to kidney disease; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16639_N","null","null","null","null","null","<p align=""justify"">The 5 mg strength tablet should be used in malabsorption states only.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16640_16575_R","null","AUTHORITY_REQUIRED","16575","16640","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia</p><br/><p>The treatment must be initiated in a hospital; AND</p> <p>The treatment must be for a patient who cannot tolerate bisphosphonates due to kidney disease; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia</p><br/><p>The treatment must be initiated in a hospital; AND</p> <p>The treatment must be for a patient who cannot tolerate bisphosphonates due to kidney disease; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16641_4562_R","null","AUTHORITY_REQUIRED","4562","16641","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16642_16664_R","null","RESTRICTED","16664","16642","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Reduction of breast cancer risk</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have a moderate or high risk of developing breast cancer; AND</p> <p>The treatment must not exceed a dose of 20 mg per day; AND</p> <p>The treatment must not exceed a lifetime maximum of 5 years for this condition; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Reduction of breast cancer risk</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have a moderate or high risk of developing breast cancer; AND</p> <p>The treatment must not exceed a dose of 20 mg per day; AND</p> <p>The treatment must not exceed a lifetime maximum of 5 years for this condition; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16643_5887_R","null","AUTHORITY_REQUIRED","5887","16643","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past; AND</p> <p>Patient must be one in whom drug interactions have occurred with other suitable PBS-listed drugs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past; AND</p> <p>Patient must be one in whom drug interactions have occurred with other suitable PBS-listed drugs.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16644_5860_R","null","AUTHORITY_REQUIRED","5860","16644","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past; AND</p> <p>Patient must be one in whom drug interactions are expected to occur with other suitable PBS-listed drugs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past; AND</p> <p>Patient must be one in whom drug interactions are expected to occur with other suitable PBS-listed drugs.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16649_5325_R","null","STREAMLINED","5325","16649","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must have experienced an average of 3 or more migraines per month over a period of at least 6 months; AND</p> <p>Patient must have a contraindication to beta-blockers, as described in the relevant TGA-approved Product Information; or</p> <p>Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with a beta-blocker; AND</p> <p>Patient must have a contraindication to pizotifen because the weight gain associated with this drug poses an unacceptable risk; or</p> <p>Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with pizotifen.</p> <p>Details of the contraindication and/or intolerance(s) must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must have experienced an average of 3 or more migraines per month over a period of at least 6 months; AND</p> <p>Patient must have a contraindication to beta-blockers, as described in the relevant TGA-approved Product Information; or</p> <p>Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with a beta-blocker; AND</p> <p>Patient must have a contraindication to pizotifen because the weight gain associated with this drug poses an unacceptable risk; or</p> <p>Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with pizotifen.</p> <p>Details of the contraindication and/or intolerance(s) must be documented in the patient&apos;s medical records when treatment is initiated.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16650_16533_R","null","RESTRICTED","16533","16650","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be stabilised on concomitant treatment with levodopa decarboxylase inhibitor combinations and entacapone; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be stabilised on concomitant treatment with levodopa decarboxylase inhibitor combinations and entacapone; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16652_16541_R","null","RESTRICTED","16541","16652","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Late stage Parkinson disease</p><br/><p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Late stage Parkinson disease</p><br/><p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16654_15580_R","null","RESTRICTED","15580","16654","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe depression</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe depression</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16655_8738_R","Continuing treatment","AUTHORITY_REQUIRED","8738","16655","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Amyotrophic lateral sclerosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be ambulatory; or</p> <p>Patient must not be ambulatory, and must be able to either use upper limbs or to swallow; AND</p> <p>Patient must not have undergone a tracheostomy; AND</p> <p>Patient must not have experienced respiratory failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Amyotrophic lateral sclerosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be ambulatory; or</p> <p>Patient must not be ambulatory, and must be able to either use upper limbs or to swallow; AND</p> <p>Patient must not have undergone a tracheostomy; AND</p> <p>Patient must not have experienced respiratory failure.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16656_16656_R","null","STREAMLINED","16656","16656","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate ulcerative colitis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mild to moderate ulcerative colitis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16660_16659_R","null","AUTHORITY_REQUIRED","16659","16660","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16661_4979_R","null","STREAMLINED","4979","16661","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Patient must be symptomatic with NYHA classes II or III; AND</p> <p>Patient must be in sinus rhythm; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 35%; AND</p> <p>Patient must have a resting heart rate at or above 77 bpm at the time ivabradine treatment is initiated; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include the maximum tolerated dose of a beta-blocker, unless contraindicated or not tolerated.</p> <p>Resting heart rate should be measured by ECG or echocardiography, after 5 minutes rest.</p> <p>The ECG or echocardiography, result must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Patient must be symptomatic with NYHA classes II or III; AND</p> <p>Patient must be in sinus rhythm; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 35%; AND</p> <p>Patient must have a resting heart rate at or above 77 bpm at the time ivabradine treatment is initiated; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include the maximum tolerated dose of a beta-blocker, unless contraindicated or not tolerated.</p> <p>Resting heart rate should be measured by ECG or echocardiography, after 5 minutes rest.</p> <p>The ECG or echocardiography, result must be documented in the patient&apos;s medical records when treatment is initiated.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16662_5177_R","null","RESTRICTED","5177","16662","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe refractory hypertension</p><br/><p>The treatment must be initiated by a consultant physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe refractory hypertension</p><br/><p>The treatment must be initiated by a consultant physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16663_6189_R","null","STREAMLINED","6189","16663","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>Patient must have lower urinary tract symptoms; AND</p> <p>Patient must have moderate to severe benign prostatic hyperplasia.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>Patient must have lower urinary tract symptoms; AND</p> <p>Patient must have moderate to severe benign prostatic hyperplasia.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16665_5850_R","null","AUTHORITY_REQUIRED","5850","16665","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past; AND</p> <p>Patient must be one in whom transfer to another suitable PBS-listed drug is likely to result in adverse clinical consequences.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Migraine attack</p><br/><p>The condition must have usually failed to respond to analgesics in the past; AND</p> <p>Patient must be one in whom transfer to another suitable PBS-listed drug is likely to result in adverse clinical consequences.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16666_16520_R","null","RESTRICTED","16520","16666","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epilepsy</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epilepsy</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16668_N","null","null","null","null","null","<p align=""justify"">For item codes 2414C and 1810G, pharmaceutical benefits that have the form tablet 20 mg are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16671_16651_R","null","RESTRICTED","16651","16671","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Patient must be experiencing fluctuations in motor function due to end-of-dose effect; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Patient must be experiencing fluctuations in motor function due to end-of-dose effect; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16671_C","null","null","null","null","null","<p align=""justify"">Appropriate contraceptive measures should be taken by women of child-bearing age in whom spironolactone therapy has been initiated.</p>","N","Y","N","null","null","N","2015-08-01","N","4708"
"16672_5950_R","null","AUTHORITY_REQUIRED","5950","16672","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Insomnia</p><br/><p>Patient must be receiving this drug for the management of insomnia; AND</p> <p>Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; AND</p> <p>Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Insomnia</p><br/><p>Patient must be receiving this drug for the management of insomnia; AND</p> <p>Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; AND</p> <p>Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16673_C","null","null","null","null","null","<p align=""justify"">Prochlorperazine may be associated with parkinsonism and tardive dyskinesia and should be used for short-term treatment only.</p>","N","Y","N","null","null","N","2015-08-01","N","4708"
"16674_C","null","null","null","null","null","<p>Sulfonylureas may cause hypoglycaemia, particularly in the elderly.</p>","N","Y","N","null","null","N","2015-08-01","N","4708"
"16675_6202_R","null","STREAMLINED","6202","16675","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>Patient must have lower urinary tract symptoms; AND</p> <p>Patient must have moderate to severe benign prostatic hyperplasia; AND</p> <p>The treatment must be in combination with an alpha-antagonist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Benign prostatic hyperplasia</p><br/><p>Patient must have lower urinary tract symptoms; AND</p> <p>Patient must have moderate to severe benign prostatic hyperplasia; AND</p> <p>The treatment must be in combination with an alpha-antagonist.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16677_16510_R","null","STREAMLINED","16510","16677","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothyroidism</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be for replacement therapy; AND</p> <p>Patient must have documented intolerance to levothyroxine sodium; or</p> <p>Patient must have documented resistance to levothyroxine sodium; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothyroidism</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be for replacement therapy; AND</p> <p>Patient must have documented intolerance to levothyroxine sodium; or</p> <p>Patient must have documented resistance to levothyroxine sodium; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16678_N","null","null","null","null","null","<p align=""justify"">The spray should not be inhaled.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16679_N","null","null","null","null","null","<p align=""justify"">No applications for increased maximum quantities and/or repeats will be authorised for the 320 mg tablet.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16680_16670_R","null","RESTRICTED","16670","16680","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must not be drug induced; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must not be drug induced; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16681_16621_R","null","RESTRICTED","16621","16681","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must not be drug induced; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must not be drug induced; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16682_16538_R","null","RESTRICTED","16538","16682","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Late stage Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Late stage Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16683_16699_R","null","STREAMLINED","16699","16683","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperkinetic extrapyramidal disorders</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperkinetic extrapyramidal disorders</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16684_6251_R","null","RESTRICTED","6251","16684","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Obsessive-compulsive disorder</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Obsessive-compulsive disorder</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16685_16676_R","null","STREAMLINED","16676","16685","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothyroidism</p><br/><p>The treatment must be for replacement therapy; AND</p> <p>Patient must have documented intolerance to levothyroxine sodium; or</p> <p>Patient must have documented resistance to levothyroxine sodium; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothyroidism</p><br/><p>The treatment must be for replacement therapy; AND</p> <p>Patient must have documented intolerance to levothyroxine sodium; or</p> <p>Patient must have documented resistance to levothyroxine sodium; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16686_16514_R","null","STREAMLINED","16514","16686","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Giant cell tumour of bone</p><br/><p>Patient must be one in whom surgical resection is not feasible; or</p> <p>Patient must be one in whom surgical resection is possible but surgery would result in significant morbidity; AND</p> <p>Patient must be an adult; or</p> <p>Patient must be a skeletally mature adolescent; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Giant cell tumour of bone</p><br/><p>Patient must be one in whom surgical resection is not feasible; or</p> <p>Patient must be one in whom surgical resection is possible but surgery would result in significant morbidity; AND</p> <p>Patient must be an adult; or</p> <p>Patient must be a skeletally mature adolescent; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16687_16579_R","null","RESTRICTED","16579","16687","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Reduction of breast cancer risk</p><br/><p>Patient must have a moderate or high risk of developing breast cancer; AND</p> <p>The treatment must not exceed a dose of 20 mg per day; AND</p> <p>The treatment must not exceed a lifetime maximum of 5 years for this condition; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Reduction of breast cancer risk</p><br/><p>Patient must have a moderate or high risk of developing breast cancer; AND</p> <p>The treatment must not exceed a dose of 20 mg per day; AND</p> <p>The treatment must not exceed a lifetime maximum of 5 years for this condition; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16689_16624_R","null","RESTRICTED","16624","16689","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be one in which fluctuations in motor function are not adequately controlled by frequent dosing with conventional formulations of levodopa with decarboxylase inhibitor; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be one in which fluctuations in motor function are not adequately controlled by frequent dosing with conventional formulations of levodopa with decarboxylase inhibitor; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16691_16537_R","null","STREAMLINED","16537","16691","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperkinetic extrapyramidal disorders</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperkinetic extrapyramidal disorders</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16693_6300_R","null","RESTRICTED","6300","16693","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depression</p><br/><p>The treatment must be for use when other anti-depressant therapy is contraindicated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depression</p><br/><p>The treatment must be for use when other anti-depressant therapy is contraindicated.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16694_6250_R","null","RESTRICTED","6250","16694","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cataplexy</p><br/><p>The condition must be associated with narcolepsy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cataplexy</p><br/><p>The condition must be associated with narcolepsy.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16700_6299_R","null","RESTRICTED","6299","16700","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phobic disorders</p><br/><p>Patient must be an adult.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phobic disorders</p><br/><p>Patient must be an adult.</p>","N","N","N","IMMEDIATE","ALL","N","2025-06-01","N","4708"
"16701_16701_R","null","STREAMLINED","16701","16701","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic cholangiocarcinoma</p><br/><p>Patient must have a test of tumour tissue confirming the presence of an IDH1 R132 variant; AND</p> <p>Patient must have had systemic therapy for this condition prior to initiating treatment with this drug for this condition; AND</p> <p>Patient must have/have had a WHO performance status of 2 or less at treatment initiation with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Confirm that evidence of the presence of a pathogenic variant of the IDH1 gene is documented/retained in the patient&apos;s medical records once only with the first PBS prescription.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic cholangiocarcinoma</p><br/><p>Patient must have a test of tumour tissue confirming the presence of an IDH1 R132 variant; AND</p> <p>Patient must have had systemic therapy for this condition prior to initiating treatment with this drug for this condition; AND</p> <p>Patient must have/have had a WHO performance status of 2 or less at treatment initiation with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Confirm that evidence of the presence of a pathogenic variant of the IDH1 gene is documented/retained in the patient&apos;s medical records once only with the first PBS prescription.</p>","N","N","N","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16708_16737_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","16737","16708","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16711_16766_R","Subsequent continuing treatment, whole body","AUTHORITY_REQUIRED","16766","16711","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16712_16713_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","16713","16712","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16714_16778_R","Subsequent continuing treatment","STREAMLINED","16778","16714","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16715_16743_R","Initial treatment - Initial 1, Whole body (new patient)","AUTHORITY_REQUIRED","16743","16715","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">It is recommended that an assessment of a patient&apos;s response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">It is recommended that an assessment of a patient&apos;s response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16719_16720_R","Subsequent continuing treatment, whole body","STREAMLINED","16720","16719","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16721_16777_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","16777","16721","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16722_16728_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","16728","16722","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; or</p> <p>Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.</p> <p align=""justify"">Active joints are defined as:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measurements must be no more than 4 weeks old at the time of this application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; or</p> <p>Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.</p> <p align=""justify"">Active joints are defined as:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measurements must be no more than 4 weeks old at the time of this application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16723_9386_R","Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply","AUTHORITY_REQUIRED","9386","16723","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16723_C","null","null","null","null","null","<p align=""justify"">Serum sickness-like reactions have been reported with this drug, especially in children.</p>","N","Y","N","null","null","N","2015-08-01","N","4708"
"16724_16725_R","First continuing treatment","AUTHORITY_REQUIRED","16725","16724","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16726_9081_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","9081","16726","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16728_N","null","null","null","null","null","<p>The dose should be adjusted in accordance with renal function.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16729_12123_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","12123","16729","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16735_16735_R","null","STREAMLINED","16735","16735","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Patient must have received a hematopoietic stem-cell transplant; or</p> <p>Patient must have received a solid-organ transplant; AND</p> <p>Patient must have a cytomegalovirus infection or cytomegalovirus disease that is resistant, refractory or intolerant/contraindicated to appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; or</p> <p>Patient must have received and is intolerant to continued use of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; AND</p> <p>The treatment must be used as monotherapy for this condition under this restriction; AND</p> <p>Patient must not have previously demonstrated resistance to this drug; AND</p> <p>Patient must not have cytomegalovirus disease that involves the central nervous system; AND</p> <p>Patient must not have cytomegalovirus retinitis.</p> <p align=""justify"">For the purpose of administering this restriction:</p><p align=""justify"">(i) A patient is determined to be refractory if after at least two weeks of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet, they fail to achieve a greater than 1log10 decrease in cytomegalovirus DNA level.</p><p align=""justify"">(ii) A patient is determined to be resistant by the identification of a genetic alteration that decreases susceptibility to ganciclovir, valganciclovir, cidofovir or foscarnet.</p><p align=""justify"">(iii) A patient with Grade 3 neutropenia (an absolute neutrophil count less than 1000 cells per cubic millimetre) or impaired renal function (creatinine clearance less than 50 mL/min) is determined to be intolerant/contraindicated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Patient must have received a hematopoietic stem-cell transplant; or</p> <p>Patient must have received a solid-organ transplant; AND</p> <p>Patient must have a cytomegalovirus infection or cytomegalovirus disease that is resistant, refractory or intolerant/contraindicated to appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; or</p> <p>Patient must have received and is intolerant to continued use of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; AND</p> <p>The treatment must be used as monotherapy for this condition under this restriction; AND</p> <p>Patient must not have previously demonstrated resistance to this drug; AND</p> <p>Patient must not have cytomegalovirus disease that involves the central nervous system; AND</p> <p>Patient must not have cytomegalovirus retinitis.</p> <p align=""justify"">For the purpose of administering this restriction:</p><p align=""justify"">(i) A patient is determined to be refractory if after at least two weeks of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet, they fail to achieve a greater than 1log10 decrease in cytomegalovirus DNA level.</p><p align=""justify"">(ii) A patient is determined to be resistant by the identification of a genetic alteration that decreases susceptibility to ganciclovir, valganciclovir, cidofovir or foscarnet.</p><p align=""justify"">(iii) A patient with Grade 3 neutropenia (an absolute neutrophil count less than 1000 cells per cubic millimetre) or impaired renal function (creatinine clearance less than 50 mL/min) is determined to be intolerant/contraindicated.</p>","N","N","N","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16737_C","null","null","null","null","null","<p align=""justify"">Nitrofurantoin may cause peripheral neuritis and severe pulmonary reactions.</p>","N","Y","N","null","null","N","2015-08-01","N","4708"
"16738_16772_R","Subsequent continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","16772","16738","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16739_16750_R","Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply","AUTHORITY_REQUIRED","16750","16739","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16740_16747_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","16747","16740","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted for the purposes of administering this restriction can be found on the Services Australia website at www.servicesaustralia.gov.au</p> <p align=""justify"">For details on the appropriate minimum exercise program that will be accepted for the purposes of administering this restriction, please refer to the Services Australia website at www.servicesaustralia.gov.au</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16741_C","null","null","null","null","null","<p align=""justify"">Regular blood and urine checks are essential.</p>","N","Y","N","null","null","N","2015-08-01","N","4708"
"16742_16789_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","16789","16742","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16744_16787_R","Subsequent continuing treatment","STREAMLINED","16787","16744","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p>","N","N","N","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16745_9064_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","9064","16745","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16745_C","null","null","null","null","null","<p align=""justify"">There is an increased risk of severe adverse reactions with this combination in the elderly.</p>","N","Y","N","null","null","N","2015-08-01","N","4708"
"16746_16710_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","16710","16746","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16749_16754_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","16754","16749","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug within this treatment cycle, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug within this treatment cycle, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16751_16727_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","16727","16751","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.</p> <p/><p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p/><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either </p><p/><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p/><p align=""justify"">(b) at least 4 active joints from the following list:</p><p/><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p/><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p><p/><p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. </p><p/><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.</p> <p/><p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p/><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either </p><p/><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p/><p align=""justify"">(b) at least 4 active joints from the following list:</p><p/><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p/><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p><p/><p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. </p><p/><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted for the following purposes:</p><p align=""justify"">(a) exempting a patient from the requirement to undertake a minimum 3 month trial of methotrexate at a 20 mg weekly dose;</p><p align=""justify"">(b) substituting azathioprine, cyclosporin or sodium aurothiomalate for another DMARD as part of the 6 month intensive DMARD trial;</p><p align=""justify"">(c) exempting a patient from the requirement for a 6 month trial of intensive DMARD therapy.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16752_16792_R","First continuing treatment, Whole body","AUTHORITY_REQUIRED","16792","16752","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16756_16780_R","Initial treatment","AUTHORITY_REQUIRED","16780","16756","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early breast cancer</p><br/><p>Initial treatment</p><br/><p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>Patient must have received neoadjuvant or adjuvant chemotherapy; AND</p> <p>The treatment must be adjuvant to surgical resection; AND</p> <p>The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene variant; AND</p> <p>Patient must have received neoadjuvant chemotherapy, and residual invasive cancer is confirmed in the breast and/or resected lymph nodes (pathological complete response was not achieved); or</p> <p>Patient must have received adjuvant chemotherapy for triple negative breast cancer, and has either: (a) node positive disease is present, (b) a primary tumour greater than 20 mm; or</p> <p>Patient must have received adjuvant chemotherapy for hormone receptor positive breast cancer, and has at least 4 positive lymph nodes; AND</p> <p>The treatment must not be a PBS-subsidised benefit beyond the following, whichever comes first: (i) a total of 52 weeks of treatment (including any non-PBS-subsidised supply), (ii) disease recurrence. Mark any remaining repeat prescriptions with the word ''cancelled'' where (i)/(ii) has occurred; AND</p> <p>The treatment must be commenced within 12 weeks of completing other therapy noting that other therapy can be any of the following therapy: (i) surgery, (ii) radiotherapy, (iii) chemotherapy; AND</p> <p>The treatment must not in combination with any of the following: (i) abemaciclib, (ii) pembrolizumab, (iii) ribociclib.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records.</p> <p align=""justify"">Treatment with this drug for this condition is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early breast cancer</p><br/><p>Initial treatment</p><br/><p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>Patient must have received neoadjuvant or adjuvant chemotherapy; AND</p> <p>The treatment must be adjuvant to surgical resection; AND</p> <p>The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene variant; AND</p> <p>Patient must have received neoadjuvant chemotherapy, and residual invasive cancer is confirmed in the breast and/or resected lymph nodes (pathological complete response was not achieved); or</p> <p>Patient must have received adjuvant chemotherapy for triple negative breast cancer, and has either: (a) node positive disease is present, (b) a primary tumour greater than 20 mm; or</p> <p>Patient must have received adjuvant chemotherapy for hormone receptor positive breast cancer, and has at least 4 positive lymph nodes; AND</p> <p>The treatment must not be a PBS-subsidised benefit beyond the following, whichever comes first: (i) a total of 52 weeks of treatment (including any non-PBS-subsidised supply), (ii) disease recurrence. Mark any remaining repeat prescriptions with the word ''cancelled'' where (i)/(ii) has occurred; AND</p> <p>The treatment must be commenced within 12 weeks of completing other therapy noting that other therapy can be any of the following therapy: (i) surgery, (ii) radiotherapy, (iii) chemotherapy; AND</p> <p>The treatment must not in combination with any of the following: (i) abemaciclib, (ii) pembrolizumab, (iii) ribociclib.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records.</p> <p align=""justify"">Treatment with this drug for this condition is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16760_16773_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16773","16760","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16762_16785_R","Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16785","16762","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16767_16775_R","First continuing treatment","AUTHORITY_REQUIRED","16775","16767","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16767_N","null","null","null","null","null","<p align=""justify"">As prochlorperazine may be associated with parkinsonism and tardive dyskinesia it should be used for short-term treatment only. However, authorities for increased maximum quantities and/or repeats of prochlorperazine tablets will be granted for the treatment of emesis associated with malignant disease.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16768_16779_R","Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","16779","16768","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16769_16761_R","Initial treatment - Initial 1, Face, hand, foot (new patient)","AUTHORITY_REQUIRED","16761","16769","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">It is recommended that an assessment of a patient&apos;s response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">It is recommended that an assessment of a patient&apos;s response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16770_5637_R","null","RESTRICTED","5637","16770","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Trachoma</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Trachoma</p>","N","N","N","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16776_16795_R","Subsequent continuing treatment, face, hand, foot","STREAMLINED","16795","16776","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16782_16788_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","16788","16782","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16783_16709_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","16709","16783","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16786_16763_R","Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","16763","16786","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16793_16716_R","Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","16716","16793","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16794_16718_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","16718","16794","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16796_16430_R","Continuing treatment","STREAMLINED","16430","16796","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have undergone surgery for this condition in the last 3 months; AND</p> <p>Patient must not have a history of, nor currently have any of the following: (i) osteoporosis, (ii) risk of other metabolic bone disease; AND</p> <p>Must be treated by a specialist medical practitioner with experience in the diagnosis and management of endometriosis; AND</p> <p>Patient must be pre-menopausal.</p> <p align=""justify"">The prescriber must only request for this treatment phase for the patient if ongoing treatment with this drug is likely to result in an adequate response.</p> <p align=""justify"">Details of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) for continuing treatment beyond 6 months if under 41 years of age must be documented in the patient&apos;s medical record.</p> <p align=""justify"">Assessment of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) is recommended at baseline, after the first 52 weeks of treatment, and annually thereafter. Depending on the degree of change in BMD, the benefit and risks of Ryeqo may need to be reconsidered. Use is recommended to be limited to 24 months, with extension of therapy conditional on stability of DXA and reassessment of risk/benefit in the individual patient by the treating physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have undergone surgery for this condition in the last 3 months; AND</p> <p>Patient must not have a history of, nor currently have any of the following: (i) osteoporosis, (ii) risk of other metabolic bone disease; AND</p> <p>Must be treated by a specialist medical practitioner with experience in the diagnosis and management of endometriosis; AND</p> <p>Patient must be pre-menopausal.</p> <p align=""justify"">The prescriber must only request for this treatment phase for the patient if ongoing treatment with this drug is likely to result in an adequate response.</p> <p align=""justify"">Details of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) for continuing treatment beyond 6 months if under 41 years of age must be documented in the patient&apos;s medical record.</p> <p align=""justify"">Assessment of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) is recommended at baseline, after the first 52 weeks of treatment, and annually thereafter. Depending on the degree of change in BMD, the benefit and risks of Ryeqo may need to be reconsidered. Use is recommended to be limited to 24 months, with extension of therapy conditional on stability of DXA and reassessment of risk/benefit in the individual patient by the treating physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16801_16765_R","First continuing treatment","AUTHORITY_REQUIRED","16765","16801","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16803_16764_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16764","16803","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16804_16429_R","Initial treatment","STREAMLINED","16429","16804","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p><br/><p>Initial treatment</p><br/><p>Patient must have experienced moderate to severe pain associated with endometriosis; AND</p> <p>The condition must be visually proven; AND</p> <p>Patient must have received an inadequate response to, or be intolerant to, previous first line therapies for this condition, including at least one of the following: (i) hormonal contraceptives, (ii) analgesics; AND</p> <p>Patient must not have undergone surgery for this condition in the last 3 months; or</p> <p>Patient must not commence this treatment until 3 months post-surgery; AND</p> <p>Patient must not have a history of, nor currently have any of the following: (i) osteoporosis, (ii) risk of other metabolic bone disease; AND</p> <p>Must be treated by a specialist medical practitioner with experience in the diagnosis and management of endometriosis; AND</p> <p>Patient must be pre-menopausal; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Assessment of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) is recommended at baseline, after the first 52 weeks of treatment, and annually thereafter. Depending on the degree of change in BMD, the benefit and risks of Ryeqo may need to be reconsidered. Use is recommended to be limited to 24 months, with extension of therapy conditional on stability of DXA and reassessment of risk/benefit in the individual patient by the treating physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p><br/><p>Initial treatment</p><br/><p>Patient must have experienced moderate to severe pain associated with endometriosis; AND</p> <p>The condition must be visually proven; AND</p> <p>Patient must have received an inadequate response to, or be intolerant to, previous first line therapies for this condition, including at least one of the following: (i) hormonal contraceptives, (ii) analgesics; AND</p> <p>Patient must not have undergone surgery for this condition in the last 3 months; or</p> <p>Patient must not commence this treatment until 3 months post-surgery; AND</p> <p>Patient must not have a history of, nor currently have any of the following: (i) osteoporosis, (ii) risk of other metabolic bone disease; AND</p> <p>Must be treated by a specialist medical practitioner with experience in the diagnosis and management of endometriosis; AND</p> <p>Patient must be pre-menopausal; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Assessment of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) is recommended at baseline, after the first 52 weeks of treatment, and annually thereafter. Depending on the degree of change in BMD, the benefit and risks of Ryeqo may need to be reconsidered. Use is recommended to be limited to 24 months, with extension of therapy conditional on stability of DXA and reassessment of risk/benefit in the individual patient by the treating physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16806_16806_R","null","STREAMLINED","16806","16806","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Patient must have received a hematopoietic stem-cell transplant; or</p> <p>Patient must have received a solid-organ transplant; AND</p> <p>Patient must have a cytomegalovirus infection or cytomegalovirus disease that is resistant, refractory or intolerant/contraindicated to appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; or</p> <p>Patient must have received and is intolerant to continued use of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; AND</p> <p>The treatment must be used as monotherapy for this condition under this restriction; AND</p> <p>Patient must not have previously demonstrated resistance to this drug; AND</p> <p>Patient must not have cytomegalovirus disease that involves the central nervous system; AND</p> <p>Patient must not have cytomegalovirus retinitis.</p> <p align=""justify"">For the purpose of administering this restriction:</p><p align=""justify"">(i) A patient is determined to be refractory if after at least two weeks of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet, they fail to achieve a greater than 1log10 decrease in cytomegalovirus DNA level.</p><p align=""justify"">(ii) A patient is determined to be resistant by the identification of a genetic alteration that decreases susceptibility to ganciclovir, valganciclovir, cidofovir or foscarnet.</p><p align=""justify"">(iii) A patient with Grade 3 neutropenia (an absolute neutrophil count less than 1000 cells per cubic millimetre) or impaired renal function (creatinine clearance less than 50 mL/min) is determined to be intolerant/contraindicated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Patient must have received a hematopoietic stem-cell transplant; or</p> <p>Patient must have received a solid-organ transplant; AND</p> <p>Patient must have a cytomegalovirus infection or cytomegalovirus disease that is resistant, refractory or intolerant/contraindicated to appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; or</p> <p>Patient must have received and is intolerant to continued use of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet; AND</p> <p>The treatment must be used as monotherapy for this condition under this restriction; AND</p> <p>Patient must not have previously demonstrated resistance to this drug; AND</p> <p>Patient must not have cytomegalovirus disease that involves the central nervous system; AND</p> <p>Patient must not have cytomegalovirus retinitis.</p> <p align=""justify"">For the purpose of administering this restriction:</p><p align=""justify"">(i) A patient is determined to be refractory if after at least two weeks of appropriately dosed ganciclovir, valganciclovir, cidofovir or foscarnet, they fail to achieve a greater than 1log10 decrease in cytomegalovirus DNA level.</p><p align=""justify"">(ii) A patient is determined to be resistant by the identification of a genetic alteration that decreases susceptibility to ganciclovir, valganciclovir, cidofovir or foscarnet.</p><p align=""justify"">(iii) A patient with Grade 3 neutropenia (an absolute neutrophil count less than 1000 cells per cubic millimetre) or impaired renal function (creatinine clearance less than 50 mL/min) is determined to be intolerant/contraindicated.</p>","N","N","N","IMMEDIATE","ALL","N","2025-07-01","N","4708"
"16807_16717_R","Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16717","16807","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-07-01","Y","4708"
"16813_16814_R","Continuing treatment","STREAMLINED","16814","16813","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 36 cumulative months from the first administered dose, once in a lifetime.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records.</p> <p align=""justify"">Patients with a body weight of 30 kg or less during continuing treatment must receive weight-based dosing, equivalent to durvalumab 20 mg/kg, until weight is greater than 30 kg.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 36 cumulative months from the first administered dose, once in a lifetime.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records.</p> <p align=""justify"">Patients with a body weight of 30 kg or less during continuing treatment must receive weight-based dosing, equivalent to durvalumab 20 mg/kg, until weight is greater than 30 kg.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16815_16953_R","Initial treatment covering the first 6 treatment cycles","STREAMLINED","16953","16815","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Initial treatment covering the first 6 treatment cycles</p><br/><p>Patient must have deficient mismatch repair (dMMR) endometrial cancer, as determined by immunohistochemistry test; AND</p> <p>The condition must be unsuitable for at least one of the following: (i) curative surgical resection, (ii) curative radiotherapy; AND</p> <p>The treatment must be initiated in combination with platinum-containing chemotherapy; AND</p> <p>The condition must be, at treatment initiation with this drug, either: (i) untreated with systemic therapy, (ii) treated with neoadjuvant/adjuvant systemic therapy, but the cancer has recurred or progressed after more than 6 months from the last dose of systemic therapy; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Initial treatment covering the first 6 treatment cycles</p><br/><p>Patient must have deficient mismatch repair (dMMR) endometrial cancer, as determined by immunohistochemistry test; AND</p> <p>The condition must be unsuitable for at least one of the following: (i) curative surgical resection, (ii) curative radiotherapy; AND</p> <p>The treatment must be initiated in combination with platinum-containing chemotherapy; AND</p> <p>The condition must be, at treatment initiation with this drug, either: (i) untreated with systemic therapy, (ii) treated with neoadjuvant/adjuvant systemic therapy, but the cancer has recurred or progressed after more than 6 months from the last dose of systemic therapy; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16816_16937_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16937","16816","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted for the purposes of administering this restriction can be found on the Services Australia website at www.servicesaustralia.gov.au</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16827_16866_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","16866","16827","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>The treatment must not exceed a single dose to be administered at week 0 under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>The treatment must not exceed a single dose to be administered at week 0 under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16830_16868_R","Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","16868","16830","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16831_16832_R","Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16832","16831","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16833_16835_R","Subsequent continuing treatment, Whole body","STREAMLINED","16835","16833","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16834_16967_R","Subsequent continuing treatment, Face, hand, foot","STREAMLINED","16967","16834","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16837_11120_R","Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","11120","16837","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16840_16841_R","Initial treatment","AUTHORITY_REQUIRED","16841","16840","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High-risk neuroblastoma</p><br/><p>Initial treatment</p><br/><p>Patient must have high-risk neuroblastoma according to a validated risk classification system; AND</p> <p>Patient must be in remission, with at least a partial response, at the end of multiagent, multimodality therapy for high-risk neuroblastoma; AND</p> <p>The treatment must be initiated after completing previous therapy; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated in a hospital/cancer centre by either a: (i) paediatric oncologist, (ii) haematologist.</p> <p align=""justify"">Prior to initiating treatment with this drug, a complete blood count, liver function tests and baseline hearing assessments should be performed and documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of the authority application, the prescriber should request an appropriate quantity and number of repeats based on the patient&apos;s Body Surface Area (BSA), according to the dosing schedule in the TGA approved Product Information.</p><p align=""justify"">The following maximum quantity units and repeats may be authorised under this restriction (providing 3 months of therapy for each prescription).</p><p align=""justify"">Up to a maximum quantity of 100 units and 1 repeat for a BSA 0.25 m<sup>2</sup> to less than 0.5 m<sup>2</sup>;</p><p align=""justify"">Up to a maximum quantity of 200 units and 1 repeat for a BSA 0.5 m<sup>2</sup> to less than 0.75 m<sup>2</sup>;</p><p align=""justify"">Up to a maximum quantity of 200 units and 2 repeats for a BSA 0.75 m<sup>2</sup> to 1.5 m<sup>2</sup>;</p><p align=""justify"">Up to a maximum quantity of 300 units and 2 repeats for a BSA greater than 1.5 m<sup>2</sup>.</p> <p align=""justify"">Authority applications for initial treatment must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed PBS authority application form, relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) details of prior multiagent, multimodality therapy for high-risk neuroblastoma [date of commencement and duration of therapy]; and</p><p align=""justify"">(ii) the patient&apos;s BSA measurement.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High-risk neuroblastoma</p><br/><p>Initial treatment</p><br/><p>Patient must have high-risk neuroblastoma according to a validated risk classification system; AND</p> <p>Patient must be in remission, with at least a partial response, at the end of multiagent, multimodality therapy for high-risk neuroblastoma; AND</p> <p>The treatment must be initiated after completing previous therapy; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated in a hospital/cancer centre by either a: (i) paediatric oncologist, (ii) haematologist.</p> <p align=""justify"">Prior to initiating treatment with this drug, a complete blood count, liver function tests and baseline hearing assessments should be performed and documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of the authority application, the prescriber should request an appropriate quantity and number of repeats based on the patient&apos;s Body Surface Area (BSA), according to the dosing schedule in the TGA approved Product Information.</p><p align=""justify"">The following maximum quantity units and repeats may be authorised under this restriction (providing 3 months of therapy for each prescription).</p><p align=""justify"">Up to a maximum quantity of 100 units and 1 repeat for a BSA 0.25 m<sup>2</sup> to less than 0.5 m<sup>2</sup>;</p><p align=""justify"">Up to a maximum quantity of 200 units and 1 repeat for a BSA 0.5 m<sup>2</sup> to less than 0.75 m<sup>2</sup>;</p><p align=""justify"">Up to a maximum quantity of 200 units and 2 repeats for a BSA 0.75 m<sup>2</sup> to 1.5 m<sup>2</sup>;</p><p align=""justify"">Up to a maximum quantity of 300 units and 2 repeats for a BSA greater than 1.5 m<sup>2</sup>.</p> <p align=""justify"">Authority applications for initial treatment must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed PBS authority application form, relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) details of prior multiagent, multimodality therapy for high-risk neuroblastoma [date of commencement and duration of therapy]; and</p><p align=""justify"">(ii) the patient&apos;s BSA measurement.</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16840_C","null","null","null","null","null","<p>This drug is a category X drug and must not be given to pregnant women. Pregnancy in female patients or in the partners of male patients must be avoided during treatment and for 1 month after cessation of treatment.</p>","N","Y","N","null","null","N","2015-08-01","N","4708"
"16842_16928_R","Initial treatment - New patient (gating mutations)","AUTHORITY_REQUIRED","16928","16842","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment - New patient (gating mutations)</p><br/><p>Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND</p> <p>Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; or</p> <p>Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged 1 month or older.</p> <p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.</p><p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.</p> <p align=""justify"">Ivacaftor is not PBS-subsidised for this condition as a sole therapy.</p><p align=""justify"">Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating G551D mutation or other gating (Class III) mutation on the CFTR gene - quote each of the: (a) the specific CFTR mutation listed in the TGA-approved Product Information, (b) name of the pathology report provider, (c) date of pathology report, (d) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment - New patient (gating mutations)</p><br/><p>Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND</p> <p>Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; or</p> <p>Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged 1 month or older.</p> <p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.</p><p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.</p> <p align=""justify"">Ivacaftor is not PBS-subsidised for this condition as a sole therapy.</p><p align=""justify"">Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating G551D mutation or other gating (Class III) mutation on the CFTR gene - quote each of the: (a) the specific CFTR mutation listed in the TGA-approved Product Information, (b) name of the pathology report provider, (c) date of pathology report, (d) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16843_16878_R","Initial treatment - New patient (gating mutations)","AUTHORITY_REQUIRED","16878","16843","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment - New patient (gating mutations)</p><br/><p>Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND</p> <p>Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; or</p> <p>Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged 4 months or older.</p> <p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.</p><p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.</p> <p align=""justify"">Ivacaftor is not PBS-subsidised for this condition as a sole therapy.</p><p align=""justify"">Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating G551D mutation or other gating (Class III) mutation on the CFTR gene - quote each of the: (a) the specific CFTR mutation listed in the TGA-approved Product Information, (b) name of the pathology report provider, (c) date of pathology report, (d) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment - New patient (gating mutations)</p><br/><p>Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND</p> <p>Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; or</p> <p>Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged 4 months or older.</p> <p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.</p><p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.</p> <p align=""justify"">Ivacaftor is not PBS-subsidised for this condition as a sole therapy.</p><p align=""justify"">Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating G551D mutation or other gating (Class III) mutation on the CFTR gene - quote each of the: (a) the specific CFTR mutation listed in the TGA-approved Product Information, (b) name of the pathology report provider, (c) date of pathology report, (d) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">For the purposes of this restriction, the list of gating mutations are: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16846_16846_R","Continuing treatment","STREAMLINED","16846","16846","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An adequate response to omalizumab treatment is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).</p> <p align=""justify"">For second and subsequent continuing treatment with this drug, a measurement of response to the prior course of therapy must be documented in the patient&apos;s medical records. The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">The following information must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(b) If applicable, maintenance oral corticosteroid dose; and</p><p align=""justify"">(c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An adequate response to omalizumab treatment is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).</p> <p align=""justify"">For second and subsequent continuing treatment with this drug, a measurement of response to the prior course of therapy must be documented in the patient&apos;s medical records. The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">The following information must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(b) If applicable, maintenance oral corticosteroid dose; and</p><p align=""justify"">(c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16848_16881_R","Initial treatment","STREAMLINED","16881","16848","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND</p> <p>Patient must not have experienced disease progression whilst on either: (i) PD-1 inhibitor treatment, (ii) CTLA-4 inhibitor treatment, if previously treated for resected or resectable melanoma; or</p> <p>Patient must not have experienced disease recurrence within 6 months of completing either: (i) PD-1 inhibitor treatment, (ii) CTLA-4 inhibitor treatment, if previously treated for resected or resectable melanoma; AND</p> <p>Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND</p> <p>The condition must not be uveal melanoma; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must weigh 40 kg or more; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen.</p> <p align=""left"">The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.</p><p align=""left"">The prescription must include the amount of nivolumab with relatlimab (Opdualag) that is appropriate to be prescribed for the patient. For the purposes of PBS subsidy, the maximum amount requested is based on the nivolumab dose only. The prescribed amount of nivolumab must be expressed in milligrams.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND</p> <p>Patient must not have experienced disease progression whilst on either: (i) PD-1 inhibitor treatment, (ii) CTLA-4 inhibitor treatment, if previously treated for resected or resectable melanoma; or</p> <p>Patient must not have experienced disease recurrence within 6 months of completing either: (i) PD-1 inhibitor treatment, (ii) CTLA-4 inhibitor treatment, if previously treated for resected or resectable melanoma; AND</p> <p>Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND</p> <p>The condition must not be uveal melanoma; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must weigh 40 kg or more; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen.</p> <p align=""left"">The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.</p><p align=""left"">The prescription must include the amount of nivolumab with relatlimab (Opdualag) that is appropriate to be prescribed for the patient. For the purposes of PBS subsidy, the maximum amount requested is based on the nivolumab dose only. The prescribed amount of nivolumab must be expressed in milligrams.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16849_16950_R","Initial treatment - 3 weekly treatment regimen","STREAMLINED","16950","16849","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment - 3 weekly treatment regimen</p><br/><p>Patient must not have received prior treatment with nivolumab plus relatlimab, ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND</p> <p>Patient must not have experienced disease progression whilst on either: (i) PD-1 inhibitor treatment, (ii) CTLA-4 inhibitor treatment, if previously treated for resected or resectable melanoma; or</p> <p>Patient must not have experienced disease recurrence within 6 months of completing either: (i) PD-1 inhibitor treatment, (ii) CTLA-4 inhibitor treatment, if previously treated for resected or resectable melanoma; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a total of 6 doses under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment - 3 weekly treatment regimen</p><br/><p>Patient must not have received prior treatment with nivolumab plus relatlimab, ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND</p> <p>Patient must not have experienced disease progression whilst on either: (i) PD-1 inhibitor treatment, (ii) CTLA-4 inhibitor treatment, if previously treated for resected or resectable melanoma; or</p> <p>Patient must not have experienced disease recurrence within 6 months of completing either: (i) PD-1 inhibitor treatment, (ii) CTLA-4 inhibitor treatment, if previously treated for resected or resectable melanoma; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a total of 6 doses under this restriction.</p> <p align=""justify"">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16850_16933_R","Initial treatment - 6 weekly treatment regimen","STREAMLINED","16933","16850","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment - 6 weekly treatment regimen</p><br/><p>Patient must not have received prior treatment with nivolumab plus relatlimab, ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND</p> <p>Patient must not have experienced disease progression whilst on either: (i) PD-1 inhibitor treatment, (ii) CTLA-4 inhibitor treatment, if previously treated for resected or resectable melanoma; or</p> <p>Patient must not have experienced disease recurrence within 6 months of completing either: (i) PD-1 inhibitor treatment, (ii) CTLA-4 inhibitor treatment, if previously treated for resected or resectable melanoma; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a total of 3 doses under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Initial treatment - 6 weekly treatment regimen</p><br/><p>Patient must not have received prior treatment with nivolumab plus relatlimab, ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND</p> <p>Patient must not have experienced disease progression whilst on either: (i) PD-1 inhibitor treatment, (ii) CTLA-4 inhibitor treatment, if previously treated for resected or resectable melanoma; or</p> <p>Patient must not have experienced disease recurrence within 6 months of completing either: (i) PD-1 inhibitor treatment, (ii) CTLA-4 inhibitor treatment, if previously treated for resected or resectable melanoma; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a total of 3 doses under this restriction.</p> <p align=""justify"">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16851_16935_R","Initial treatment","AUTHORITY_REQUIRED","16935","16851","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB, IIIC, IIID or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be in addition to complete surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> <p align=""left"">When nivolumab is initially prescribed as a 3-weekly dosing regimen, patients must only receive a maximum of 240 mg every 3 weeks for 2 cycles (i.e., 1 repeat). When prescribed as a weight based or flat dose adjuvant regimen, patients must only receive a maximum of 240 mg every 2 weeks or 480 mg every 4 weeks for a maximum of 12 months of adjuvant treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB, IIIC, IIID or Stage IV malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be in addition to complete surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> <p align=""left"">When nivolumab is initially prescribed as a 3-weekly dosing regimen, patients must only receive a maximum of 240 mg every 3 weeks for 2 cycles (i.e., 1 repeat). When prescribed as a weight based or flat dose adjuvant regimen, patients must only receive a maximum of 240 mg every 2 weeks or 480 mg every 4 weeks for a maximum of 12 months of adjuvant treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16854_16854_R","Subsequent continuing treatment","STREAMLINED","16854","16854","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16855_16899_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","16899","16855","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16858_16911_R","Subsequent continuing treatment (Face, hand, foot)","STREAMLINED","16911","16858","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment (Face, hand, foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment (Face, hand, foot) - treatment covering week 28 and onwards restrictions; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""left"">The assessment of response to treatment must be provided in this application and documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment (Face, hand, foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment (Face, hand, foot) - treatment covering week 28 and onwards restrictions; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""left"">The assessment of response to treatment must be provided in this application and documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16860_N","null","null","null","null","null","<p align=""justify"">The enteric coated preparations are for patients with a significant risk of gastrointestinal bleeding.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16861_N","null","null","null","null","null","<p align=""justify"">Application to large areas of skin for longer than four weeks is not recommended.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16862_N","null","null","null","null","null","<p align=""justify"">For patients who have failed to respond to simple moisturising agents.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16863_N","null","null","null","null","null","<p align=""justify"">To be used in conjunction with the scalp cleanser salicylic acid with coal tar solution and pine tar (code 4447C).</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16864_16915_R","First continuing treatment","AUTHORITY_REQUIRED","16915","16864","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16864_N","null","null","null","null","null","<p>Smith &amp; Nephew products are distributed via the three major wholesalers, API, Sigma &amp; Symbion. To best ensure product availability at RPBS agreed prices, please order from one of these suppliers. In the event that your preferred wholesaler cannot supply, please contact Smith &amp; Nephew Customer Service on 13 13 60. Smith &amp; Nephew cannot ensure RPBS pricing from distributors other than those aforementioned.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16865_16939_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16939","16865","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must not exceed a single dose to be administered at week 0 under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must not exceed a single dose to be administered at week 0 under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16865_C","null","null","null","null","null","<p align=""justify"">Because of variable effects of food on absorption of sustained release theophylline preparations, patients stabilised on one brand should not be changed to another without appropriate monitoring.</p>","N","Y","N","null","null","N","2015-11-01","N","4708"
"16866_N","null","null","null","null","null","<p align=""justify"">Suitable for yellow sloughy infected and malodorous wounds.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16867_16944_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16944","16867","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted between 8 and 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) details of the two proposed prescriptions; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological medicine treatment including details of date and duration of treatment.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 1 vial or pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">The most recent fistula assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised</p> <p align=""justify"">Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient&apos;s weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.</p> <p align=""left"">Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted between 8 and 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) details of the two proposed prescriptions; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological medicine treatment including details of date and duration of treatment.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 1 vial or pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">The most recent fistula assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised</p> <p align=""justify"">Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient&apos;s weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.</p> <p align=""left"">Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16867_N","null","null","null","null","null","<p align=""justify"">Authorities for increased maximum quantities and/or repeats will not be granted except as detailed under the &apos;Authority required&apos; listing of nitrazepam.</p>","Y","N","N","null","null","N","2015-11-01","N","4708"
"16868_N","null","null","null","null","null","<p align=""justify"">This dressing should be used only on moderately to heavily exuding wounds and should remain in place until saturated or for a maximum of 3 days.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16869_16900_R","Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16900","16869","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16869_N","null","null","null","null","null","<p>Paper wasp venom is not European wasp venom</p>","Y","N","N","null","null","N","2015-11-01","N","4708"
"16870_16896_R","First continuing treatment, Whole body","AUTHORITY_REQUIRED","16896","16870","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16870_N","null","null","null","null","null","<p align=""justify"">This dressing should remain in place until saturated or up to a maximum of 7 days. Allow a minimum of 2 cm to 3 cm in excess of the wound size of the dressing around the wound.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16871_16927_R","First continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","16927","16871","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16871_N","null","null","null","null","null","<p align=""justify"">Molnlycke Healthcare products are distributed through leading pharmacy distributors. To best ensure product availability at RPBS agreed prices, special arrangements have been made with API and Independence Australia Health Solutions (IAHS). IAHS orders can be placed on: Tel: 1300 788 855; or Email customerservice@independenceaustralia.com. Molnlycke Healthcare are not able to ensure product availability or pricing on listed products beyond these two suppliers.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16872_16920_R","Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","16920","16872","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16872_N","null","null","null","null","null","<p align=""justify"">Authorities for increased maximum quantities and/or repeats will not be granted except as detailed under the &apos;Authority required&apos; listing of oxazepam.</p>","Y","N","N","null","null","N","2015-11-01","N","4708"
"16873_N","null","null","null","null","null","<p align=""justify"">This dressing should remain in place until saturated or strike through occurs for a maximum of 7 days.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16874_N","null","null","null","null","null","<p align=""justify"">This dressing should be applied to a thickness of 3 mm to 5 mm. It should be covered with a hydrocolloid dressing and may be left in place for up to 7 days.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16877_16876_R","Continuing treatment (gating mutations)","AUTHORITY_REQUIRED","16876","16877","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment (gating mutations)</p><br/><p>Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND</p> <p>Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged 4 months or older.</p> <p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.</p><p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.</p> <p align=""justify"">Ivacaftor is not PBS-subsidised for this condition as a sole therapy.</p><p align=""justify"">Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment (gating mutations)</p><br/><p>Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND</p> <p>Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged 4 months or older.</p> <p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.</p><p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.</p> <p align=""justify"">Ivacaftor is not PBS-subsidised for this condition as a sole therapy.</p><p align=""justify"">Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16877_N","null","null","null","null","null","<p align=""justify"">This dressing should be applied to a thickness of 3 mm to 5 mm and remain in situ in infected wounds for 24 hours and in clean wounds for up to 3 days. It should be covered with a secondary dressing such as foam or film. It should not be covered with gauze or combine.</p>","Y","N","N","null","null","N","2015-08-01","N","4708"
"16880_16906_R","Initial treatment","AUTHORITY_REQUIRED","16906","16880","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spontaneous urticaria</p><br/><p>Initial treatment</p><br/><p>Must be treated by a clinical immunologist; or</p> <p>Must be treated by an allergist; or</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU); AND</p> <p>The condition must be based on both physical examination and patient history (to exclude any factors that may be triggering the urticaria); AND</p> <p>Patient must have experienced itch and hives that persist on a daily basis for at least 6 weeks despite treatment with H1 antihistamines; AND</p> <p>Patient must have failed to achieve an adequate response after a minimum of 2 weeks treatment with a standard therapy; AND</p> <p>Patient must not receive more than 12 weeks of treatment under this restriction.</p> <p align=""justify"">A standard therapy is defined as a combination of therapies that includes H1 antihistamines at maximally tolerated doses in accordance with clinical guidelines, and one of the following:</p><p align=""justify"">1) a H2 receptor antagonist (150 mg twice per day); or</p><p align=""justify"">2) a leukotriene receptor antagonist (LTRA) (10 mg per day); or</p><p align=""justify"">3) doxepin (up to 25 mg three times a day)</p> <p align=""justify"">If the requirement for treatment with H1 antihistamines and a H2 receptor antagonist, or a leukotriene receptor antagonist or doxepin cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the authority application.</p> <p align=""justify"">A failure to achieve an adequate response to standard therapy is defined as a current Urticaria Activity Score 7 (UAS7) score of equal to or greater than 28 with an itch score of greater than 8, as assessed while still on standard therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Chronic Spontaneous Urticaria Omalizumab Initial PBS Authority Application - Supporting Information Form which must include:</p><p align=""justify"">(i) demonstration of failure to achieve an adequate response to standard therapy; and</p><p align=""justify"">(ii) drug names and doses of standard therapies that the patient has failed; and</p><p align=""justify"">(iii) a signed patient acknowledgment that cessation of therapy should be considered after the patient has demonstrated clinical benefit with omalizumab to re-evaluate the need for continued therapy. Any patient who ceases therapy and whose CSU relapses will need to re-initiate PBS-subsidised omalizumab as a new patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spontaneous urticaria</p><br/><p>Initial treatment</p><br/><p>Must be treated by a clinical immunologist; or</p> <p>Must be treated by an allergist; or</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU); AND</p> <p>The condition must be based on both physical examination and patient history (to exclude any factors that may be triggering the urticaria); AND</p> <p>Patient must have experienced itch and hives that persist on a daily basis for at least 6 weeks despite treatment with H1 antihistamines; AND</p> <p>Patient must have failed to achieve an adequate response after a minimum of 2 weeks treatment with a standard therapy; AND</p> <p>Patient must not receive more than 12 weeks of treatment under this restriction.</p> <p align=""justify"">A standard therapy is defined as a combination of therapies that includes H1 antihistamines at maximally tolerated doses in accordance with clinical guidelines, and one of the following:</p><p align=""justify"">1) a H2 receptor antagonist (150 mg twice per day); or</p><p align=""justify"">2) a leukotriene receptor antagonist (LTRA) (10 mg per day); or</p><p align=""justify"">3) doxepin (up to 25 mg three times a day)</p> <p align=""justify"">If the requirement for treatment with H1 antihistamines and a H2 receptor antagonist, or a leukotriene receptor antagonist or doxepin cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the authority application.</p> <p align=""justify"">A failure to achieve an adequate response to standard therapy is defined as a current Urticaria Activity Score 7 (UAS7) score of equal to or greater than 28 with an itch score of greater than 8, as assessed while still on standard therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Chronic Spontaneous Urticaria Omalizumab Initial PBS Authority Application - Supporting Information Form which must include:</p><p align=""justify"">(i) demonstration of failure to achieve an adequate response to standard therapy; and</p><p align=""justify"">(ii) drug names and doses of standard therapies that the patient has failed; and</p><p align=""justify"">(iii) a signed patient acknowledgment that cessation of therapy should be considered after the patient has demonstrated clinical benefit with omalizumab to re-evaluate the need for continued therapy. Any patient who ceases therapy and whose CSU relapses will need to re-initiate PBS-subsidised omalizumab as a new patient.</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16882_16882_R","Maintenance therapy","STREAMLINED","16882","16882","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>The treatment must have been commenced by a specialist physician; or</p> <p>The treatment must have been commenced by a physician who has consulted a specialist physician with expertise in the management of Parkinson''s disease; AND</p> <p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>The treatment must have been commenced by a specialist physician; or</p> <p>The treatment must have been commenced by a physician who has consulted a specialist physician with expertise in the management of Parkinson''s disease; AND</p> <p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy.</p> <p align=""justify"">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16883_16883_R","null","STREAMLINED","16883","16883","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Must be treated by a specialist physician; or</p> <p>Must be treated by a physician who has consulted a specialist physician with expertise in the management of Parkinson''s disease; AND</p> <p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Must be treated by a specialist physician; or</p> <p>Must be treated by a physician who has consulted a specialist physician with expertise in the management of Parkinson''s disease; AND</p> <p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy.</p> <p align=""justify"">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16884_16909_R","Subsequent continuing treatment","STREAMLINED","16909","16884","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16891_16958_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","16958","16891","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>The treatment must not exceed a single dose to be administered at week 0 under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy).</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>The treatment must not exceed a single dose to be administered at week 0 under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy).</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16892_16829_R","Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","16829","16892","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have an externally draining enterocutaneous or rectovaginal fistula; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) details of the two proposed prescriptions; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition of no more than 4 weeks old at the time of application.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 1 vial or pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised</p> <p align=""justify"">Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient&apos;s weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.</p> <p align=""left"">Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have an externally draining enterocutaneous or rectovaginal fistula; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(1) details of the two proposed prescriptions; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition of no more than 4 weeks old at the time of application.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 1 vial or pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised</p> <p align=""justify"">Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient&apos;s weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.</p> <p align=""left"">Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16893_16922_R","Initial treatment - Initial 1, Face, hand, foot (new patient)","AUTHORITY_REQUIRED","16922","16893","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16895_12156_R","Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply","AUTHORITY_REQUIRED","12156","16895","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16897_16856_R","First continuing, Subsequent continuing treatment - balance of supply","AUTHORITY_REQUIRED","16856","16897","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing, Subsequent continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing, Subsequent continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16898_16885_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","16885","16898","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16902_16845_R","Continuing treatment (non-gating mutations)","AUTHORITY_REQUIRED","16845","16902","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment (non-gating mutations)</p><br/><p>Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND</p> <p>Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged 4 months or older.</p> <p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.</p><p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.</p> <p align=""justify"">Ivacaftor is not PBS-subsidised for this condition as a sole therapy.</p><p align=""justify"">Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment (non-gating mutations)</p><br/><p>Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND</p> <p>Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged 4 months or older.</p> <p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.</p><p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.</p> <p align=""justify"">Ivacaftor is not PBS-subsidised for this condition as a sole therapy.</p><p align=""justify"">Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16905_16905_R","Continuing treatment","STREAMLINED","16905","16905","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spontaneous urticaria</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist; or</p> <p>Must be treated by an allergist; or</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU); AND</p> <p>Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks per authorised course of treatment under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spontaneous urticaria</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist; or</p> <p>Must be treated by an allergist; or</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU); AND</p> <p>Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks per authorised course of treatment under this restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16908_16812_R","null","STREAMLINED","16812","16908","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Must be treated by a specialist physician; or</p> <p>Must be treated by a physician who has consulted a specialist physician with expertise in the management of Parkinson''s disease; AND</p> <p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Must be treated by a specialist physician; or</p> <p>Must be treated by a physician who has consulted a specialist physician with expertise in the management of Parkinson''s disease; AND</p> <p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy.</p> <p align=""justify"">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16912_16886_R","Subsequent continuing treatment (Whole body)","STREAMLINED","16886","16912","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment (Whole body)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment (Whole body) - treatment covering week 28 and onwards restrictions; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""left"">The assessment of response to treatment must be provided in this application and documented in the patient&apos;s medical records.</p> <p>The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment (Whole body)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment (Whole body) - treatment covering week 28 and onwards restrictions; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""left"">The assessment of response to treatment must be provided in this application and documented in the patient&apos;s medical records.</p> <p>The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16919_16919_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","16919","16919","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks.</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16921_16894_R","Initial treatment - Initial 1, Whole body (new patient)","AUTHORITY_REQUIRED","16894","16921","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16923_16945_R","Subsequent continuing treatment","STREAMLINED","16945","16923","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16924_16924_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","16924","16924","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16926_16976_R","Subsequent continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","16976","16926","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align=""justify"">It is recommended that an application for the continuing treatment is submitted to Services Australia no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align=""justify"">It is recommended that an application for the continuing treatment is submitted to Services Australia no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16929_16844_R","Initial treatment - New patient (non-gating mutations)","AUTHORITY_REQUIRED","16844","16929","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment - New patient (non-gating mutations)</p><br/><p>Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND</p> <p>Patient must have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data; AND</p> <p>Patient must not have either: (i) G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; (ii) other gating (class III) mutation in the CFTR gene; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged 4 months or older.</p> <p align=""justify"">For the purposes of this restriction, the list of mutations considered to be responsive to ivacaftor is defined in the TGA approved Product Information.</p> <p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.</p><p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.</p> <p align=""justify"">Ivacaftor is not PBS-subsidised for this condition as a sole therapy.</p><p align=""justify"">Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating the specific mutation considered to be responsive to ivacaftor as listed in the TGA-approved Product Information. Quote each of the: (a) the specific mutation listed in the TGA-approved Product Information, (b) name of the pathology report provider, (c) date of pathology report, (d) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment - New patient (non-gating mutations)</p><br/><p>Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND</p> <p>Patient must have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data; AND</p> <p>Patient must not have either: (i) G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; (ii) other gating (class III) mutation in the CFTR gene; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged 4 months or older.</p> <p align=""justify"">For the purposes of this restriction, the list of mutations considered to be responsive to ivacaftor is defined in the TGA approved Product Information.</p> <p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.</p><p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.</p> <p align=""justify"">Ivacaftor is not PBS-subsidised for this condition as a sole therapy.</p><p align=""justify"">Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating the specific mutation considered to be responsive to ivacaftor as listed in the TGA-approved Product Information. Quote each of the: (a) the specific mutation listed in the TGA-approved Product Information, (b) name of the pathology report provider, (c) date of pathology report, (d) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16934_16962_R","Continuing treatment","AUTHORITY_REQUIRED","16962","16934","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB, IIIC, IIID or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have undergone surgical resection; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> <p align=""justify"">When prescribed as a weight based or flat dose adjuvant regimen, patients must receive a maximum of 240 mg every 2 weeks or 480 mg every 4 weeks for a maximum of 12 months of adjuvant treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB, IIIC, IIID or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have undergone surgical resection; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.</p> <p align=""justify"">When prescribed as a weight based or flat dose adjuvant regimen, patients must receive a maximum of 240 mg every 2 weeks or 480 mg every 4 weeks for a maximum of 12 months of adjuvant treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16940_16916_R","First continuing, Subsequent continuing treatment - balance of supply","AUTHORITY_REQUIRED","16916","16940","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>First continuing, Subsequent continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>First continuing, Subsequent continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16941_16917_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","16917","16941","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>The treatment must not exceed a single dose to be administered at week 8 under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy).</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>The treatment must not exceed a single dose to be administered at week 8 under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy (dosage, date of commencement and duration of therapy).</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16942_16943_R","First continuing treatment","AUTHORITY_REQUIRED","16943","16942","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>First continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>First continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks.</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16947_16971_R","Initial treatment - New patient (non-gating mutations)","AUTHORITY_REQUIRED","16971","16947","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment - New patient (non-gating mutations)</p><br/><p>Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND</p> <p>Patient must have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data; AND</p> <p>Patient must not have either: (i) G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; (ii) other gating (class III) mutation in the CFTR gene; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged 1 month or older.</p> <p align=""justify"">For the purposes of this restriction, the list of mutations considered to be responsive to ivacaftor is defined in the TGA approved Product Information.</p> <p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.</p><p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.</p> <p align=""justify"">Ivacaftor is not PBS-subsidised for this condition as a sole therapy.</p><p align=""justify"">Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating the specific mutation considered to be responsive to ivacaftor as listed in the TGA-approved Product Information. Quote each of the: (a) the specific mutation listed in the TGA-approved Product Information, (b) name of the pathology report provider, (c) date of pathology report, (d) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment - New patient (non-gating mutations)</p><br/><p>Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND</p> <p>Patient must have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data; AND</p> <p>Patient must not have either: (i) G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; (ii) other gating (class III) mutation in the CFTR gene; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged 1 month or older.</p> <p align=""justify"">For the purposes of this restriction, the list of mutations considered to be responsive to ivacaftor is defined in the TGA approved Product Information.</p> <p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.</p><p align=""justify"">Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.</p> <p align=""justify"">Ivacaftor is not PBS-subsidised for this condition as a sole therapy.</p><p align=""justify"">Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating the specific mutation considered to be responsive to ivacaftor as listed in the TGA-approved Product Information. Quote each of the: (a) the specific mutation listed in the TGA-approved Product Information, (b) name of the pathology report provider, (c) date of pathology report, (d) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16949_16949_R","Continuing treatment","STREAMLINED","16949","16949","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An adequate response to omalizumab treatment is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).</p> <p align=""justify"">For second and subsequent continuing treatment with this drug, a measurement of response to the prior course of therapy must be documented in the patient&apos;s medical records. The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">The following information must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(b) If applicable, maintenance oral corticosteroid dose; and</p><p align=""justify"">(c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An adequate response to omalizumab treatment is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction).</p> <p align=""justify"">For second and subsequent continuing treatment with this drug, a measurement of response to the prior course of therapy must be documented in the patient&apos;s medical records. The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">The following information must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(b) If applicable, maintenance oral corticosteroid dose; and</p><p align=""justify"">(c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16951_16951_R","Maintenance therapy","STREAMLINED","16951","16951","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>The treatment must have been commenced by a specialist physician; or</p> <p>The treatment must have been commenced by a physician who has consulted a specialist physician with expertise in the management of Parkinson''s disease; AND</p> <p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>Patient must require continuous administration of foslevodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2,400 mg of foslevodopa.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Maintenance therapy</p><br/><p>The treatment must have been commenced by a specialist physician; or</p> <p>The treatment must have been commenced by a physician who has consulted a specialist physician with expertise in the management of Parkinson''s disease; AND</p> <p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>Patient must require continuous administration of foslevodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2,400 mg of foslevodopa.</p> <p align=""justify"">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16952_16853_R","null","STREAMLINED","16853","16952","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Must be treated by a specialist physician; or</p> <p>Must be treated by a physician who has consulted a specialist physician with expertise in the management of Parkinson''s disease; AND</p> <p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>Patient must require continuous administration of foslevodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2,400 mg of foslevodopa.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Must be treated by a specialist physician; or</p> <p>Must be treated by a physician who has consulted a specialist physician with expertise in the management of Parkinson''s disease; AND</p> <p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>Patient must require continuous administration of foslevodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2,400 mg of foslevodopa.</p> <p align=""justify"">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16954_16910_R","Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","16910","16954","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16955_16925_R","First continuing treatment","AUTHORITY_REQUIRED","16925","16955","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16957_16918_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","16918","16957","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must not exceed a single dose to be administered at week 8 under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must not exceed a single dose to be administered at week 8 under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16960_16960_R","Continuing treatment","STREAMLINED","16960","16960","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spontaneous urticaria</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist; or</p> <p>Must be treated by an allergist; or</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU); AND</p> <p>Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks per authorised course of treatment under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spontaneous urticaria</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist; or</p> <p>Must be treated by an allergist; or</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU); AND</p> <p>Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks per authorised course of treatment under this restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16963_16972_R","null","STREAMLINED","16972","16963","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Must be treated by a specialist physician; or</p> <p>Must be treated by a physician who has consulted a specialist physician with expertise in the management of Parkinson''s disease; AND</p> <p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>Patient must require continuous administration of foslevodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2,400 mg of foslevodopa.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Parkinson disease</p><br/><p>Must be treated by a specialist physician; or</p> <p>Must be treated by a physician who has consulted a specialist physician with expertise in the management of Parkinson''s disease; AND</p> <p>Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND</p> <p>Patient must require continuous administration of foslevodopa without an overnight break; or</p> <p>Patient must require a total daily dose of more than 2,400 mg of foslevodopa.</p> <p align=""justify"">Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16964_16818_R","First continuing, Subsequent continuing treatment - balance of supply (Whole body, or, face/hand/foot)","AUTHORITY_REQUIRED","16818","16964","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing, Subsequent continuing treatment - balance of supply (Whole body, or, face/hand/foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing current PBS-subsidised treatment with this biological medicine, but the full number of repeats available under the continuing treatment phase was not prescribed.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing, Subsequent continuing treatment - balance of supply (Whole body, or, face/hand/foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing current PBS-subsidised treatment with this biological medicine, but the full number of repeats available under the continuing treatment phase was not prescribed.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16973_16973_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","16973","16973","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-08-01","N","4708"
"16974_16828_R","Initial treatment - initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","16828","16974","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>The treatment must not exceed a single dose to be administered at week 8 under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>The treatment must not exceed a single dose to be administered at week 8 under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""left"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align=""justify"">Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p>","N","N","N","FULL","ALL","N","2025-08-01","Y","4708"
"16975_16836_R","Subsequent continuing treatment, Whole body","AUTHORITY_REQUIRED","16836","16975","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">It is recommended that an application for the continuing treatment is submitted to Services Australia no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate dosage, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">It is recommended that an application for the continuing treatment is submitted to Services Australia no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-08-01","Y","4708"
"16980_16991_R","Subsequent continuing treatment","STREAMLINED","16991","16980","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"16981_16982_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","16982","16981","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"16984_17032_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","17032","16984","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; or</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine (adalimumab or infliximab) for this condition in this treatment cycle if aged 6 to 17 years; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; or</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle more than once if aged 6 to 17 years; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient&apos;s condition if relevant; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; or</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine (adalimumab or infliximab) for this condition in this treatment cycle if aged 6 to 17 years; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; or</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle more than once if aged 6 to 17 years; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient&apos;s condition if relevant; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"16985_17030_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","17030","16985","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under this restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under this restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"16987_16993_R","First continuing treatment","AUTHORITY_REQUIRED","16993","16987","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>First continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""left"">Authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction for patients who:</p><p align=""left"">(i) received fewer than 5 repeats at the time of application; and/or</p><p align=""left"">(ii) required changes to their dosing regimen during this treatment phase.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>First continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""left"">Authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction for patients who:</p><p align=""left"">(i) received fewer than 5 repeats at the time of application; and/or</p><p align=""left"">(ii) required changes to their dosing regimen during this treatment phase.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"16988_17077_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","17077","16988","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); or</p> <p>Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient&apos;s response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); or</p> <p>Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient&apos;s response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"16989_17031_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","17031","16989","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); or</p> <p>Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient&apos;s response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); or</p> <p>Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient&apos;s response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"16999_16999_R","Subsequent continuing treatment, Face, hand, foot","STREAMLINED","16999","16999","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must have been under 18 years of age at the time of initial treatment with this drug.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must have been under 18 years of age at the time of initial treatment with this drug.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17004_17045_R","Initial 2 treatment (Face, hand, foot) - Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years","AUTHORITY_REQUIRED","17045","17004","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 2 treatment (Face, hand, foot) - Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years</p><br/><p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND</p> <p>Patient must not receive more than 17 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the patient is changing from treatment with etanercept a baseline PASI measurement must be provided with this authority application.</p> <p align=""left"">Response to preceding supply:</p><p align=""left"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""left"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""left"">(ii) a reduction by 75% or more in the skin area affected, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p><p align=""left"">Change in therapy:</p><p align=""left"">If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:</p><p align=""left"">(i) there is an absence of an adequate response to that treatment; or</p><p align=""left"">(ii) there was an intolerance to that treatment; or</p><p align=""left"">(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above</p><p align=""left"">Recommencing therapy:</p><p align=""left"">If the patient is recommencing therapy, in relation to the last administered dose, state whether there was:</p><p align=""left"">(i) an absence of an adequate response; or</p><p align=""left"">(ii) an intolerance to that treatment; or</p><p align=""left"">(iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.</p> <p align=""justify"">The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 2 treatment (Face, hand, foot) - Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years</p><br/><p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND</p> <p>Patient must not receive more than 17 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the patient is changing from treatment with etanercept a baseline PASI measurement must be provided with this authority application.</p> <p align=""left"">Response to preceding supply:</p><p align=""left"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""left"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""left"">(ii) a reduction by 75% or more in the skin area affected, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p><p align=""left"">Change in therapy:</p><p align=""left"">If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:</p><p align=""left"">(i) there is an absence of an adequate response to that treatment; or</p><p align=""left"">(ii) there was an intolerance to that treatment; or</p><p align=""left"">(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above</p><p align=""left"">Recommencing therapy:</p><p align=""left"">If the patient is recommencing therapy, in relation to the last administered dose, state whether there was:</p><p align=""left"">(i) an absence of an adequate response; or</p><p align=""left"">(ii) an intolerance to that treatment; or</p><p align=""left"">(iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.</p> <p align=""justify"">The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"17005_17005_R","Initial 2 treatment (Whole body) - Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years","AUTHORITY_REQUIRED","17005","17005","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 2 treatment (Whole body) - Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years</p><br/><p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 17 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the patient is changing from treatment with etanercept a baseline PASI measurement must be provided with this authority application.</p> <p align=""justify"">Response to preceding supply:</p><p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p><p align=""justify"">Change in therapy:</p><p align=""justify"">If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:</p><p align=""justify"">(i) there is an absence of an adequate response to that treatment; or</p><p align=""justify"">(ii) there was an intolerance to that treatment; or</p><p align=""justify"">(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above</p><p align=""justify"">Recommencing therapy:</p><p align=""justify"">If the patient is recommencing therapy, in relation to the last administered dose, state whether there was:</p><p align=""justify"">(i) an absence of an adequate response; or</p><p align=""justify"">(ii) an intolerance to that treatment; or</p><p align=""justify"">(iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.</p> <p align=""justify"">The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 2 treatment (Whole body) - Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years</p><br/><p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 17 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the patient is changing from treatment with etanercept a baseline PASI measurement must be provided with this authority application.</p> <p align=""justify"">Response to preceding supply:</p><p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p><p align=""justify"">Change in therapy:</p><p align=""justify"">If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:</p><p align=""justify"">(i) there is an absence of an adequate response to that treatment; or</p><p align=""justify"">(ii) there was an intolerance to that treatment; or</p><p align=""justify"">(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above</p><p align=""justify"">Recommencing therapy:</p><p align=""justify"">If the patient is recommencing therapy, in relation to the last administered dose, state whether there was:</p><p align=""justify"">(i) an absence of an adequate response; or</p><p align=""justify"">(ii) an intolerance to that treatment; or</p><p align=""justify"">(iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.</p> <p align=""justify"">The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"17006_17016_R","Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)","AUTHORITY_REQUIRED","17016","17006","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; or</p> <p>Patient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility, (b) airway hyperresponsiveness, (c) peak expiratory flow (PEF) variability; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the last 12 months; or</p> <p>Patient must have blood eosinophil count of at least 150 cells per microlitre in the last 12 months; or</p> <p>Patient must have a fractional exhaled nitric oxide of at least 20 ppb in the last 12 months; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must be aged 6 to less than 12 years.</p> <p align=""justify"">Optimised asthma therapy includes:</p><p align=""justify"">(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;</p><p align=""justify"">AND</p><p align=""justify"">(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The initial IgE assessment<i>, </i>blood eosinophil count or fractional exhaled nitric oxide measurement must be no more than 12 months old at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),</p><p align=""justify"">AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 28 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the last dose of biological medicine, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of dupilumab of up to 32 weeks.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and</p><p align=""justify"">(b) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(c) the IgE, blood eosinophil or the fractional exhaled nitric oxide result and date; and</p><p align=""justify"">(d) Asthma Control Questionnaire (ACQ-5) score; or</p><p align=""justify"">(e) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; or</p> <p>Patient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility, (b) airway hyperresponsiveness, (c) peak expiratory flow (PEF) variability; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the last 12 months; or</p> <p>Patient must have blood eosinophil count of at least 150 cells per microlitre in the last 12 months; or</p> <p>Patient must have a fractional exhaled nitric oxide of at least 20 ppb in the last 12 months; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must be aged 6 to less than 12 years.</p> <p align=""justify"">Optimised asthma therapy includes:</p><p align=""justify"">(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;</p><p align=""justify"">AND</p><p align=""justify"">(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The initial IgE assessment<i>, </i>blood eosinophil count or fractional exhaled nitric oxide measurement must be no more than 12 months old at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),</p><p align=""justify"">AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 28 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the last dose of biological medicine, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of dupilumab of up to 32 weeks.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and</p><p align=""justify"">(b) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(c) the IgE, blood eosinophil or the fractional exhaled nitric oxide result and date; and</p><p align=""justify"">(d) Asthma Control Questionnaire (ACQ-5) score; or</p><p align=""justify"">(e) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the accepted toxicities, including severity, which will be accepted for the purposes of exempting a patient from the requirement of treatment with optimised asthma therapy.</p>","N","N","N","FULL","ALL","N","2025-09-01","Y","4708"
"17007_17073_R","Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy), Initial treatment - Initial 2 (Change of treatment), Continuing treatment, or transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements - Balance of Supply in a patient aged 6 to 12 years","AUTHORITY_REQUIRED","17073","17007","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy), Initial treatment - Initial 2 (Change of treatment), Continuing treatment, or transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements - Balance of Supply in a patient aged 6 to 12 years</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy) restriction to complete 32 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 2 (Change of treatment) restriction to complete 32 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 32 weeks treatment available under the Initial 1 and Initial 2 restriction; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing and transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy), Initial treatment - Initial 2 (Change of treatment), Continuing treatment, or transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements - Balance of Supply in a patient aged 6 to 12 years</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy) restriction to complete 32 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 2 (Change of treatment) restriction to complete 32 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 32 weeks treatment available under the Initial 1 and Initial 2 restriction; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing and transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17008_17009_R","Continuing treatment","AUTHORITY_REQUIRED","17009","17008","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must be aged 6 to less than 12 years.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">All applications for continuing treatment with this biological medicine must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate must be made at around 20 weeks after the first PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.</p><p align=""justify"">The first assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle<i>.</i></p><p align=""justify"">At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of dupilumab, sufficient for 24 weeks therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) Asthma Control Questionnaire (ACQ-5) score; or</p><p align=""justify"">(c) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must be aged 6 to less than 12 years.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">All applications for continuing treatment with this biological medicine must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate must be made at around 20 weeks after the first PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.</p><p align=""justify"">The first assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle<i>.</i></p><p align=""justify"">At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of dupilumab, sufficient for 24 weeks therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) Asthma Control Questionnaire (ACQ-5) score; or</p><p align=""justify"">(c) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.</p>","N","N","N","FULL","ALL","N","2025-09-01","Y","4708"
"17011_17102_R","Continuing treatment","STREAMLINED","17102","17011","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.</p><p align=""justify"">Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) If applicable, the baseline and maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or</p><p align=""justify"">(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and</p><p align=""justify"">(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.</p><p align=""justify"">Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) If applicable, the baseline and maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or</p><p align=""justify"">(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and</p><p align=""justify"">(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17014_17086_R","Continuing treatment","AUTHORITY_REQUIRED","17086","17014","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.</p><p align=""justify"">Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) If applicable, the baseline and maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or</p><p align=""justify"">(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and</p><p align=""justify"">(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.</p><p align=""justify"">Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) If applicable, the baseline and maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or</p><p align=""justify"">(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and</p><p align=""justify"">(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17015_17076_R","Initial treatment of the face and/or hands","AUTHORITY_REQUIRED","17076","17015","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Initial treatment of the face and/or hands</p><br/><p>The condition must have at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub-scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; or</p> <p>The condition must have affected at least 30% of the face/hands surface area despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND</p> <p>The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND</p> <p>Patient must not have experienced an inadequate response to this biological medicine in this PBS indication; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">State each of the 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) for:</p><p align=""justify"">(i) erythema,</p><p align=""justify"">(ii) oedema/papulation,</p><p align=""justify"">(iii) excoriation,</p><p align=""justify"">(iv) lichenification</p><p align=""justify"">Acceptable scores can be:</p><p align=""justify"">(a) current scores; or</p><p align=""justify"">(b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.</p><p align=""justify"">State the percentage face/hand surface area affected by the condition (must be at least 30%) where EASI symptom sub-scores are not provided. This percentage surface area can also be stated in addition to the EASI symptom sub-scores.</p><p align=""justify"">The EASI/percentage surface area and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient&apos;s medical records.</p><p align=""justify"">Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled are in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Initial treatment of the face and/or hands</p><br/><p>The condition must have at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub-scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; or</p> <p>The condition must have affected at least 30% of the face/hands surface area despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND</p> <p>The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND</p> <p>Patient must not have experienced an inadequate response to this biological medicine in this PBS indication; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">State each of the 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) for:</p><p align=""justify"">(i) erythema,</p><p align=""justify"">(ii) oedema/papulation,</p><p align=""justify"">(iii) excoriation,</p><p align=""justify"">(iv) lichenification</p><p align=""justify"">Acceptable scores can be:</p><p align=""justify"">(a) current scores; or</p><p align=""justify"">(b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.</p><p align=""justify"">State the percentage face/hand surface area affected by the condition (must be at least 30%) where EASI symptom sub-scores are not provided. This percentage surface area can also be stated in addition to the EASI symptom sub-scores.</p><p align=""justify"">The EASI/percentage surface area and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient&apos;s medical records.</p><p align=""justify"">Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled are in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17017_17017_R","Chronic treatment","AUTHORITY_REQUIRED","17017","17017","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fibrodysplasia ossificans progressiva (FOP)</p><br/><p>Chronic treatment</p><br/><p>Patient must have a diagnosis of FOP, confirmed by genetic testing; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of FOP; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of FOP; AND</p> <p>Patient must be a female aged 8 years or older; or</p> <p>Patient must be a male aged 10 years or older.</p> <p align=""justify"">At the time of the authority application, the medical practitioner must request the appropriate combination of packs to provide treatment at the recommended dose for chronic treatment, based on the age and weight of the patient, adequate for 4 weeks according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">Appropriate genetic testing constitutes testing for a pathogenic variant of the Activin A receptor type I (ACVR1) gene. Confirm that evidence of the presence of a pathogenic mutation of the ACVR1 gene is documented/retained in the patient&apos;s medical records once only with the first PBS prescription.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fibrodysplasia ossificans progressiva (FOP)</p><br/><p>Chronic treatment</p><br/><p>Patient must have a diagnosis of FOP, confirmed by genetic testing; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of FOP; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of FOP; AND</p> <p>Patient must be a female aged 8 years or older; or</p> <p>Patient must be a male aged 10 years or older.</p> <p align=""justify"">At the time of the authority application, the medical practitioner must request the appropriate combination of packs to provide treatment at the recommended dose for chronic treatment, based on the age and weight of the patient, adequate for 4 weeks according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">Appropriate genetic testing constitutes testing for a pathogenic variant of the Activin A receptor type I (ACVR1) gene. Confirm that evidence of the presence of a pathogenic mutation of the ACVR1 gene is documented/retained in the patient&apos;s medical records once only with the first PBS prescription.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"17018_17018_R","Flare-up (acute) treatment","STREAMLINED","17018","17018","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fibrodysplasia ossificans progressiva (FOP)</p><br/><p>Flare-up (acute) treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be experiencing a FOP flare-up; or</p> <p>Patient must be at high risk of a FOP flare-up; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of FOP; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of FOP; AND</p> <p>Patient must be a female aged 8 years or older; or</p> <p>Patient must be a male aged 10 years or older.</p> <p align=""justify"">Flare-up treatment should begin at the onset of the first symptom indicative of a FOP flare-up or substantial high-risk traumatic event likely to lead to a flare-up. Symptoms of a FOP flareup typically include but are not limited to localised pain, soft tissue swelling/inflammation, redness, warmth, decreased joint range of motion, and stiffness. Examples of a high risk substantial traumatic event include surgery, intramuscular immunisation, mandibular blocks for dental work, muscle fatigue, blunt muscle trauma from bumps, bruises, falls, or influenza-like viral illnesses.</p> <p align=""justify"">At the time of the authority application, the medical practitioner must request the appropriate combination of packs to provide treatment at the recommended dose for flare-up treatment based on the age and weight of the patient, adequate for 12 weeks of treatment or in the presence of persistent flare-up symptoms to extend treatment in 4-week intervals according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">If the patient experiences another flare-up (i.e., new flare-up location or marked worsening of the original flare-up) at any time during flare-up treatment, the flare-up 12-week treatment should be restarted.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fibrodysplasia ossificans progressiva (FOP)</p><br/><p>Flare-up (acute) treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be experiencing a FOP flare-up; or</p> <p>Patient must be at high risk of a FOP flare-up; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of FOP; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of FOP; AND</p> <p>Patient must be a female aged 8 years or older; or</p> <p>Patient must be a male aged 10 years or older.</p> <p align=""justify"">Flare-up treatment should begin at the onset of the first symptom indicative of a FOP flare-up or substantial high-risk traumatic event likely to lead to a flare-up. Symptoms of a FOP flareup typically include but are not limited to localised pain, soft tissue swelling/inflammation, redness, warmth, decreased joint range of motion, and stiffness. Examples of a high risk substantial traumatic event include surgery, intramuscular immunisation, mandibular blocks for dental work, muscle fatigue, blunt muscle trauma from bumps, bruises, falls, or influenza-like viral illnesses.</p> <p align=""justify"">At the time of the authority application, the medical practitioner must request the appropriate combination of packs to provide treatment at the recommended dose for flare-up treatment based on the age and weight of the patient, adequate for 12 weeks of treatment or in the presence of persistent flare-up symptoms to extend treatment in 4-week intervals according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">If the patient experiences another flare-up (i.e., new flare-up location or marked worsening of the original flare-up) at any time during flare-up treatment, the flare-up 12-week treatment should be restarted.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17020_17052_R","First continuing treatment","AUTHORITY_REQUIRED","17052","17020","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Polycythemia vera</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised treatment for this condition; AND</p> <p>Patient must have achieved and maintained a response to treatment with this drug for this condition; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">(i) Maintaining a haematocrit level of less than 45% without relying on phlebotomy and which was measured at least 12 weeks after the most recent phlebotomy procedure (if performed to reduce red blood cell levels); or</p><p align=""justify"">(ii) Ability to demonstrate or maintain a normal platelet count of less than or equal to 400 x 10<sup>9</sup>/L; or</p><p align=""justify"">(iii) The absence of palpable splenomegaly.</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (dates, unique identifying number/code, or provider number) of the pathology report confirming the patient has achieved and maintained a response within 48 weeks of treatment initiation; or</p><p align=""justify"">(b) confirmation that the patient does not have palpable splenomegaly.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Polycythemia vera</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised treatment for this condition; AND</p> <p>Patient must have achieved and maintained a response to treatment with this drug for this condition; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">(i) Maintaining a haematocrit level of less than 45% without relying on phlebotomy and which was measured at least 12 weeks after the most recent phlebotomy procedure (if performed to reduce red blood cell levels); or</p><p align=""justify"">(ii) Ability to demonstrate or maintain a normal platelet count of less than or equal to 400 x 10<sup>9</sup>/L; or</p><p align=""justify"">(iii) The absence of palpable splenomegaly.</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (dates, unique identifying number/code, or provider number) of the pathology report confirming the patient has achieved and maintained a response within 48 weeks of treatment initiation; or</p><p align=""justify"">(b) confirmation that the patient does not have palpable splenomegaly.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17021_17022_R","null","STREAMLINED","17022","17021","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Must be treated in an accredited treatment centre; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child-bearing age; AND</p> <p>Patient must have compensated liver disease; AND</p> <p>Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND</p> <p>Patient must have a contraindication to ribavirin; AND</p> <p>The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND</p> <p>The treatment must be limited to a maximum duration of 48 weeks.</p> <p align=""justify"">Evidence of chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.</p> <p>Chronic hepatitis C infection</p><br/><p>Must be treated in an accredited treatment centre; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child-bearing age; AND</p> <p>Patient must have compensated liver disease; AND</p> <p>Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND</p> <p>Patient must have a contraindication to ribavirin; AND</p> <p>The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND</p> <p>The treatment must be limited to a maximum duration of 48 weeks.</p> <p align=""justify"">Evidence of chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient&apos;s medical records.</p> <p align=""left"">Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for hepatitis C:</p><p align=""left"">(a) a nurse educator/counsellor for patients; and</p><p align=""left"">(b) 24-hour access by patients to medical advice; and</p><p align=""left"">(c) an established liver clinic.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17023_17055_R","Initial treatment - loading dose","AUTHORITY_REQUIRED","17055","17023","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neuromyelitis optica spectrum disorder (NMOSD)</p><br/><p>Initial treatment - loading dose</p><br/><p>Patient must have a confirmed diagnosis of NMOSD with aquaporin-4 immunoglobulin G auto-antibody (AQP4-IgG); AND</p> <p>Patient must have an Expanded Disability Status Scale (EDSS) score of no higher than 7; AND</p> <p>Patient must have experienced at least one relapse in the last 12 months while receiving treatment with rituximab; or</p> <p>Patient must have a documented intolerance to rituximab of a severity necessitating permanent treatment withdrawal; or</p> <p>Patient must have a documented contraindication to rituximab therapy; AND</p> <p>Patient must not receive more than 2 weeks of treatment under this restriction; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a medical practitioner who has consulted a neurologist, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for a single loading dose for induction therapy, according to the specified dosage in the approved Product Information (PI). Refer to the approved PI for patient weight ranges for the 100 mg/mL doses (consisting of 300 mg in 3 mL and 1.1 g in 11 mL vials).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) details of the proposed authority prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:</p><p align=""justify"">(i) the patient&apos;s Expanded Disability Status Scale (EDSS) score; and</p><p align=""justify"">(ii) details of prior rituximab treatment (dosage, date of commencement and duration of therapy), or details of contraindications or developed intolerances necessitating treatment withdrawal.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Neuromyelitis optica spectrum disorder (NMOSD)</p><br/><p>Initial treatment - loading dose</p><br/><p>Patient must have a confirmed diagnosis of NMOSD with aquaporin-4 immunoglobulin G auto-antibody (AQP4-IgG); AND</p> <p>Patient must have an Expanded Disability Status Scale (EDSS) score of no higher than 7; AND</p> <p>Patient must have experienced at least one relapse in the last 12 months while receiving treatment with rituximab; or</p> <p>Patient must have a documented intolerance to rituximab of a severity necessitating permanent treatment withdrawal; or</p> <p>Patient must have a documented contraindication to rituximab therapy; AND</p> <p>Patient must not receive more than 2 weeks of treatment under this restriction; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a medical practitioner who has consulted a neurologist, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for a single loading dose for induction therapy, according to the specified dosage in the approved Product Information (PI). Refer to the approved PI for patient weight ranges for the 100 mg/mL doses (consisting of 300 mg in 3 mL and 1.1 g in 11 mL vials).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) details of the proposed authority prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:</p><p align=""justify"">(i) the patient&apos;s Expanded Disability Status Scale (EDSS) score; and</p><p align=""justify"">(ii) details of prior rituximab treatment (dosage, date of commencement and duration of therapy), or details of contraindications or developed intolerances necessitating treatment withdrawal.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p>","N","N","N","FULL","ALL","N","2025-09-01","Y","4708"
"17035_17068_R","Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years","AUTHORITY_REQUIRED","17068","17035","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND</p> <p>The condition must be affecting the whole body - all subsequent authority applications to this application will be made under treatment phases that feature the words ''whole body''; or</p> <p>The condition must be limited to the face/hand/foot - all subsequent authority applications to this application will be made under treatment phases that feature the words ''face, hand, foot''; AND</p> <p>Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; or</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND</p> <p>The condition must be affecting the whole body - all subsequent authority applications to this application will be made under treatment phases that feature the words ''whole body''; or</p> <p>The condition must be limited to the face/hand/foot - all subsequent authority applications to this application will be made under treatment phases that feature the words ''face, hand, foot''; AND</p> <p>Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; or</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"17036_17069_R","Initial 2 treatment (Face, hand, foot) - Change of treatment","AUTHORITY_REQUIRED","17069","17036","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 2 treatment (Face, hand, foot) - Change of treatment</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value.</p><p align=""justify"">In relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:</p><p align=""justify"">(i) there is an absence of an adequate response to that treatment; or</p><p align=""justify"">(ii) there was an intolerance to that treatment; or</p><p align=""justify"">(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above.</p> <p align=""justify"">The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 2 treatment (Face, hand, foot) - Change of treatment</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value.</p><p align=""justify"">In relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:</p><p align=""justify"">(i) there is an absence of an adequate response to that treatment; or</p><p align=""justify"">(ii) there was an intolerance to that treatment; or</p><p align=""justify"">(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above.</p> <p align=""justify"">The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17038_17067_R","Initial 2 treatment (Whole body) - Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years","AUTHORITY_REQUIRED","17067","17038","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 2 treatment (Whole body) - Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the patient is changing from treatment with etanercept a baseline PASI measurement must be provided with this authority application.</p> <p align=""justify"">Response to preceding supply:</p><p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p><p align=""justify"">Change in therapy:</p><p align=""justify"">If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:</p><p align=""justify"">(i) there is an absence of an adequate response to that treatment; or</p><p align=""justify"">(ii) there was an intolerance to that treatment; or</p><p align=""justify"">(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above</p><p align=""justify"">Recommencing therapy:</p><p align=""justify"">If the patient is recommencing therapy, in relation to the last administered dose, state whether there was:</p><p align=""justify"">(i) an absence of an adequate response; or</p><p align=""justify"">(ii) an intolerance to that treatment; or</p><p align=""justify"">(iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.</p> <p align=""justify"">The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 2 treatment (Whole body) - Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the patient is changing from treatment with etanercept a baseline PASI measurement must be provided with this authority application.</p> <p align=""justify"">Response to preceding supply:</p><p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p><p align=""justify"">Change in therapy:</p><p align=""justify"">If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:</p><p align=""justify"">(i) there is an absence of an adequate response to that treatment; or</p><p align=""justify"">(ii) there was an intolerance to that treatment; or</p><p align=""justify"">(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above</p><p align=""justify"">Recommencing therapy:</p><p align=""justify"">If the patient is recommencing therapy, in relation to the last administered dose, state whether there was:</p><p align=""justify"">(i) an absence of an adequate response; or</p><p align=""justify"">(ii) an intolerance to that treatment; or</p><p align=""justify"">(iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.</p> <p align=""justify"">The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"17040_17039_R","Initial 2 treatment (Face, hand, foot) - Change or recommencement of treatment after a break in biological medicine of less than 5 years","AUTHORITY_REQUIRED","17039","17040","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 2 treatment (Face, hand, foot) - Change or recommencement of treatment after a break in biological medicine of less than 5 years</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the patient is changing from treatment with etanercept a baseline PASI measurement must be provided with this authority application.</p> <p align=""left"">Response to preceding supply:</p><p align=""left"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""left"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""left"">(ii) a reduction by 75% or more in the skin area affected, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p><p align=""left"">Change in therapy:</p><p align=""left"">If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:</p><p align=""left"">(i) there is an absence of an adequate response to that treatment; or</p><p align=""left"">(ii) there was an intolerance to that treatment; or</p><p align=""left"">(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above</p><p align=""left"">Recommencing therapy:</p><p align=""left"">If the patient is recommencing therapy, in relation to the last administered dose, state whether there was:</p><p align=""left"">(i) an absence of an adequate response; or</p><p align=""left"">(ii) an intolerance to that treatment; or</p><p align=""left"">(iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.</p> <p align=""justify"">The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 2 treatment (Face, hand, foot) - Change or recommencement of treatment after a break in biological medicine of less than 5 years</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the patient is changing from treatment with etanercept a baseline PASI measurement must be provided with this authority application.</p> <p align=""left"">Response to preceding supply:</p><p align=""left"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""left"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""left"">(ii) a reduction by 75% or more in the skin area affected, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p><p align=""left"">Change in therapy:</p><p align=""left"">If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:</p><p align=""left"">(i) there is an absence of an adequate response to that treatment; or</p><p align=""left"">(ii) there was an intolerance to that treatment; or</p><p align=""left"">(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above</p><p align=""left"">Recommencing therapy:</p><p align=""left"">If the patient is recommencing therapy, in relation to the last administered dose, state whether there was:</p><p align=""left"">(i) an absence of an adequate response; or</p><p align=""left"">(ii) an intolerance to that treatment; or</p><p align=""left"">(iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.</p> <p align=""justify"">The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"17041_17002_R","First continuing treatment, Whole body","AUTHORITY_REQUIRED","17002","17041","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must have been under 18 years of age at the time of initial treatment with this drug.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must have been under 18 years of age at the time of initial treatment with this drug.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.</p>","N","N","N","FULL","ALL","N","2025-09-01","Y","4708"
"17042_17042_R","Balance of supply - Initial 1, 2 or 3 treatment (Whole body, or, face/hand/foot)","AUTHORITY_REQUIRED","17042","17042","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial 1, 2 or 3 treatment (Whole body, or, face/hand/foot)</p><br/><p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>The treatment must provide no more than the balance of 17 weeks of treatment available under any of the initial treatment phases; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing current PBS-subsidised treatment with this biological medicine, but has received insufficient therapy with this biological medicine to complete 3 doses available under any of the initial treatment phases (regardless of the affected body area): (i) Initial 1, (ii) Initial 2, (iii) Initial 3.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial 1, 2 or 3 treatment (Whole body, or, face/hand/foot)</p><br/><p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>The treatment must provide no more than the balance of 17 weeks of treatment available under any of the initial treatment phases; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing current PBS-subsidised treatment with this biological medicine, but has received insufficient therapy with this biological medicine to complete 3 doses available under any of the initial treatment phases (regardless of the affected body area): (i) Initial 1, (ii) Initial 2, (iii) Initial 3.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17043_17043_R","Initial 1 treatment (Whole body) - biological medicine-naive patient","AUTHORITY_REQUIRED","17043","17043","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1 treatment (Whole body) - biological medicine-naive patient</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND</p> <p>Patient must not receive more than 17 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must be under 18 years of age.</p> <p>Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application.</p> <p>Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:</p><p align=""justify"">(a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy.</p><p align=""justify"">A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. Provide in this authority application, and document in the patient&apos;s medical records, each of:</p><p align=""justify"">(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;</p><p align=""justify"">(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);</p><p align=""justify"">(iii) the PASI score that followed each prior therapy trialled;</p><p align=""justify"">(iv) the date the PASI scores were determined.</p><p align=""justify"">Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of: (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1 treatment (Whole body) - biological medicine-naive patient</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND</p> <p>Patient must not receive more than 17 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must be under 18 years of age.</p> <p>Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application.</p> <p>Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:</p><p align=""justify"">(a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy.</p><p align=""justify"">A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. Provide in this authority application, and document in the patient&apos;s medical records, each of:</p><p align=""justify"">(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;</p><p align=""justify"">(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);</p><p align=""justify"">(iii) the PASI score that followed each prior therapy trialled;</p><p align=""justify"">(iv) the date the PASI scores were determined.</p><p align=""justify"">Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of: (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"17044_17044_R","Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient","AUTHORITY_REQUIRED","17044","17044","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient</p><br/><p>Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND</p> <p>Patient must not receive more than 17 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must be under 18 years of age.</p> <p>Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application.</p> <p>Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:</p><p align=""justify"">(a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or</p><p align=""justify"">(b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy</p><p align=""justify"">Provide in this authority application, and document in the patient&apos;s medical records, each of:</p><p align=""justify"">(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;</p><p align=""justify"">(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);</p><p align=""justify"">(iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled;</p><p align=""justify"">(iv) the dates that response assessments were determined.</p><p align=""justify"">Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment:</p><p align=""justify"">(v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);</p><p align=""justify"">(vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient</p><br/><p>Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND</p> <p>Patient must not receive more than 17 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must be under 18 years of age.</p> <p>Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application.</p> <p>Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:</p><p align=""justify"">(a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or</p><p align=""justify"">(b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy</p><p align=""justify"">Provide in this authority application, and document in the patient&apos;s medical records, each of:</p><p align=""justify"">(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;</p><p align=""justify"">(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);</p><p align=""justify"">(iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled;</p><p align=""justify"">(iv) the dates that response assessments were determined.</p><p align=""justify"">Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment:</p><p align=""justify"">(v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);</p><p align=""justify"">(vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"17046_17046_R","Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years","AUTHORITY_REQUIRED","17046","17046","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND</p> <p>The condition must be affecting the whole body - all subsequent authority applications to this application will be made under treatment phases that feature the words ''whole body''; or</p> <p>The condition must be limited to the face/hand/foot - all subsequent authority applications to this application will be made under treatment phases that feature the words ''face, hand, foot''; AND</p> <p>Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; or</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 17 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND</p> <p>The condition must be affecting the whole body - all subsequent authority applications to this application will be made under treatment phases that feature the words ''whole body''; or</p> <p>The condition must be limited to the face/hand/foot - all subsequent authority applications to this application will be made under treatment phases that feature the words ''face, hand, foot''; AND</p> <p>Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; or</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 17 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"17048_17075_R","Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)","AUTHORITY_REQUIRED","17075","17048","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; or</p> <p>Patient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility, (b) airway hyperresponsiveness, (c) peak expiratory flow (PEF) variability; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have past or current evidence of atopy, documented by either: (i) skin prick testing, (ii) an in vitro measure of specific IgE; AND</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to the time of application; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to less than 12 years; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must be under the care of the same physician for at least 6 months.</p> <p align=""justify"">Optimised asthma therapy includes:</p><p align=""justify"">(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;</p><p align=""justify"">AND</p><p align=""justify"">(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),</p><p align=""justify"">AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 24 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and</p><p align=""justify"">(b) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(c) the IgE result and date; and</p><p align=""justify"">(d) Asthma Control Questionnaire (ACQ-5) score; or</p><p align=""justify"">(e) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; or</p> <p>Patient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility, (b) airway hyperresponsiveness, (c) peak expiratory flow (PEF) variability; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have past or current evidence of atopy, documented by either: (i) skin prick testing, (ii) an in vitro measure of specific IgE; AND</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to the time of application; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to less than 12 years; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must be under the care of the same physician for at least 6 months.</p> <p align=""justify"">Optimised asthma therapy includes:</p><p align=""justify"">(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;</p><p align=""justify"">AND</p><p align=""justify"">(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),</p><p align=""justify"">AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 24 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and</p><p align=""justify"">(b) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(c) the IgE result and date; and</p><p align=""justify"">(d) Asthma Control Questionnaire (ACQ-5) score; or</p><p align=""justify"">(e) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.</p>","N","N","N","FULL","ALL","N","2025-09-01","Y","4708"
"17050_17072_R","Initial treatment - Initial 2 (Change of treatment)","AUTHORITY_REQUIRED","17072","17050","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Patient must have had a total serum human immunoglobulin E of at least 30 IU/mL with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; or</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; or</p> <p>Patient must have had a fractional exhaled nitric oxide of at least 20 ppb no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine in this treatment cycle for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must be aged 6 to less than 12 years.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma or severe allergic asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made no more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine.</p><p align=""justify"">A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the IgE, blood eosinophil or fractional exhaled nitric oxide result and date; and</p><p align=""justify"">(b) Asthma Control Questionnaire (ACQ-5) score; or</p><p align=""justify"">(c) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.</p><p align=""justify"">(d) the details of prior biological medicine treatment including the details of date and duration of treatment; and</p><p align=""justify"">(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Patient must have had a total serum human immunoglobulin E of at least 30 IU/mL with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; or</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; or</p> <p>Patient must have had a fractional exhaled nitric oxide of at least 20 ppb no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine in this treatment cycle for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must be aged 6 to less than 12 years.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma or severe allergic asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made no more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine.</p><p align=""justify"">A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the IgE, blood eosinophil or fractional exhaled nitric oxide result and date; and</p><p align=""justify"">(b) Asthma Control Questionnaire (ACQ-5) score; or</p><p align=""justify"">(c) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.</p><p align=""justify"">(d) the details of prior biological medicine treatment including the details of date and duration of treatment; and</p><p align=""justify"">(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","N","N","N","FULL","ALL","N","2025-09-01","Y","4708"
"17051_17019_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","17019","17051","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Polycythemia vera</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have achieved and maintained a response to treatment with this drug for this condition; AND</p> <p>Patient must be at least 18 years of age.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Polycythemia vera</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have achieved and maintained a response to treatment with this drug for this condition; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17053_17053_R","Initial treatment","AUTHORITY_REQUIRED","17053","17053","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Polycythemia vera</p><br/><p>Initial treatment</p><br/><p>Patient must be resistant to hydroxycarbamide (hydroxyurea); or</p> <p>Patient must have an intolerance to hydroxycarbamide (hydroxyurea) of a severity necessitating permanent treatment withdrawal; or</p> <p>Patient must have developed a clinically important adverse event/contraindication to hydroxycarbamide (hydroxyurea) as defined in the TGA-approved Product Information necessitating permanent treatment withdrawal; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Hydroxycarbamide (hydroxyurea) resistance is defined as a minimum of 12 consecutive weeks treatment at a dose of at least 1.5 grams/day or at the maximum tolerated that still results in one of the following:</p><p align=""justify"">(i) the need to reduce haematocrit levels to below 45% through phlebotomy; or</p><p align=""justify"">(ii) a platelet count greater than 400 x 10<sup>9</sup>/L and a white blood cell count greater than 10 x 10<sup>9</sup>/L</p> <p align=""justify"">If applicable, details of prior systemic treatment with hydroxycarbamide (hydroxyurea) that caused either (i) an intolerance, (ii) an adverse event as listed in the TGA-approved Product Information, or (iii) a contraindication as listed in the TGA-approved Product Information necessitating permanent treatment withdrawal should be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Polycythemia vera</p><br/><p>Initial treatment</p><br/><p>Patient must be resistant to hydroxycarbamide (hydroxyurea); or</p> <p>Patient must have an intolerance to hydroxycarbamide (hydroxyurea) of a severity necessitating permanent treatment withdrawal; or</p> <p>Patient must have developed a clinically important adverse event/contraindication to hydroxycarbamide (hydroxyurea) as defined in the TGA-approved Product Information necessitating permanent treatment withdrawal; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Hydroxycarbamide (hydroxyurea) resistance is defined as a minimum of 12 consecutive weeks treatment at a dose of at least 1.5 grams/day or at the maximum tolerated that still results in one of the following:</p><p align=""justify"">(i) the need to reduce haematocrit levels to below 45% through phlebotomy; or</p><p align=""justify"">(ii) a platelet count greater than 400 x 10<sup>9</sup>/L and a white blood cell count greater than 10 x 10<sup>9</sup>/L</p> <p align=""justify"">If applicable, details of prior systemic treatment with hydroxycarbamide (hydroxyurea) that caused either (i) an intolerance, (ii) an adverse event as listed in the TGA-approved Product Information, or (iii) a contraindication as listed in the TGA-approved Product Information necessitating permanent treatment withdrawal should be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","IMMEDIATE","ALL","N","2025-09-01","Y","4708"
"17054_17054_R","Balance of Initial treatment - up to 48 weeks","AUTHORITY_REQUIRED","17054","17054","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Polycythemia vera</p><br/><p>Balance of Initial treatment - up to 48 weeks</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised treatment for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Polycythemia vera</p><br/><p>Balance of Initial treatment - up to 48 weeks</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised treatment for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17065_17065_R","Subsequent continuing treatment, Whole body","STREAMLINED","17065","17065","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must have been under 18 years of age at the time of initial treatment with this drug.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must have been under 18 years of age at the time of initial treatment with this drug.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17074_17012_R","Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy), Initial treatment - Initial 2 (Change of treatment), Continuing treatment - Balance of Supply in a patient aged 6 to 12 years","AUTHORITY_REQUIRED","17012","17074","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy), Initial treatment - Initial 2 (Change of treatment), Continuing treatment - Balance of Supply in a patient aged 6 to 12 years</p><br/><p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy) restriction to complete 28 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 2 (Change of treatment) restriction to complete 28 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the Initial 1 and Initial 2 restriction; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy), Initial treatment - Initial 2 (Change of treatment), Continuing treatment - Balance of Supply in a patient aged 6 to 12 years</p><br/><p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy) restriction to complete 28 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 2 (Change of treatment) restriction to complete 28 weeks of treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the Initial 1 and Initial 2 restriction; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17081_17070_R","Initial 1 treatment (Whole body) - biological medicine-naive patient","AUTHORITY_REQUIRED","17070","17081","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1 treatment (Whole body) - biological medicine-naive patient</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have lesions present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p>Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application.</p> <p>Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:</p><p align=""justify"">(a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy.</p><p align=""justify"">A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. Provide in this authority application, and document in the patient&apos;s medical records, each of:</p><p align=""justify"">(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;</p><p align=""justify"">(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);</p><p align=""justify"">(iii) the PASI score that followed each prior therapy trialled;</p><p align=""justify"">(iv) the date the PASI scores were determined.</p><p align=""justify"">Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of: (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1 treatment (Whole body) - biological medicine-naive patient</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have lesions present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p>Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application.</p> <p>Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:</p><p align=""justify"">(a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy.</p><p align=""justify"">A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. Provide in this authority application, and document in the patient&apos;s medical records, each of:</p><p align=""justify"">(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;</p><p align=""justify"">(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);</p><p align=""justify"">(iii) the PASI score that followed each prior therapy trialled;</p><p align=""justify"">(iv) the date the PASI scores were determined.</p><p align=""justify"">Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of: (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"17082_17003_R","First continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","17003","17082","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must have been under 18 years of age at the time of initial treatment with this drug.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist; AND</p> <p>Patient must have been under 18 years of age at the time of initial treatment with this drug.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.</p>","N","N","N","FULL","ALL","N","2025-09-01","Y","4708"
"17083_17047_R","Initial treatment of the whole body","AUTHORITY_REQUIRED","17047","17083","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Initial treatment of the whole body</p><br/><p>Patient must have a Physicians Global Assessment (PGA) (5-point scale) baseline score of at least 4 as evidence of severe disease despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>Patient must have an Eczema Area and Severity Index (EASI) baseline score of at least 20 despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND</p> <p>The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND</p> <p>Patient must not have experienced an inadequate response to this biological medicine in this PBS indication; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">State each of the qualifying (i) PGA, (ii) EASI and (iii) DLQI scores in the authority application.</p><p align=""justify"">Acceptable scores can be:</p><p align=""justify"">(a) current scores; or</p><p align=""justify"">(b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.</p><p align=""justify"">The EASI and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient&apos;s medical records.</p><p align=""justify"">Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Initial treatment of the whole body</p><br/><p>Patient must have a Physicians Global Assessment (PGA) (5-point scale) baseline score of at least 4 as evidence of severe disease despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>Patient must have an Eczema Area and Severity Index (EASI) baseline score of at least 20 despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND</p> <p>The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND</p> <p>The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND</p> <p>Patient must not have experienced an inadequate response to this biological medicine in this PBS indication; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">State each of the qualifying (i) PGA, (ii) EASI and (iii) DLQI scores in the authority application.</p><p align=""justify"">Acceptable scores can be:</p><p align=""justify"">(a) current scores; or</p><p align=""justify"">(b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.</p><p align=""justify"">The EASI and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient&apos;s medical records.</p><p align=""justify"">Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled in the patient&apos;s medical records.</p> <p align=""justify"">Instructions on the use of the Physician&apos;s Global Assessment (5-point scale) can be obtained from Sanofi Medical Information on 1800 818 806 or MedInfo.Australia@sanofi.com</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17084_17084_R","Continuing treatment","STREAMLINED","17084","17084","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.</p><p align=""justify"">Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) If applicable, the baseline and maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or</p><p align=""justify"">(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and</p><p align=""justify"">(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.</p><p align=""justify"">Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) If applicable, the baseline and maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or</p><p align=""justify"">(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and</p><p align=""justify"">(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17092_17094_R","Subsequent continuing treatment (Whole body)","AUTHORITY_REQUIRED","17094","17092","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment (Whole body)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment (Whole body) - treatment covering week 28 and onwards restrictions; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""left"">The assessment of response to treatment must be provided in this application and documented in the patient&apos;s medical records.</p> <p>The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment (Whole body)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment (Whole body) - treatment covering week 28 and onwards restrictions; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""left"">The assessment of response to treatment must be provided in this application and documented in the patient&apos;s medical records.</p> <p>The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.</p>","N","N","N","FULL","ALL","N","2025-09-01","Y","4708"
"17095_17001_R","Initial 2 treatment (Whole body) - Change of treatment","AUTHORITY_REQUIRED","17001","17095","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 2 treatment (Whole body) - Change of treatment</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p><p align=""justify"">In relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:</p><p align=""justify"">(i) there is an absence of an adequate response to that treatment; or</p><p align=""justify"">(ii) there was an intolerance to that treatment; or</p><p align=""justify"">(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above.</p> <p align=""justify"">The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 2 treatment (Whole body) - Change of treatment</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p><p align=""justify"">In relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:</p><p align=""justify"">(i) there is an absence of an adequate response to that treatment; or</p><p align=""justify"">(ii) there was an intolerance to that treatment; or</p><p align=""justify"">(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above.</p> <p align=""justify"">The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17096_17096_R","Continuing treatment","STREAMLINED","17096","17096","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.</p><p align=""justify"">Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) If applicable, the baseline and maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or</p><p align=""justify"">(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and</p><p align=""justify"">(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.</p><p align=""justify"">Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) If applicable, the baseline and maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or</p><p align=""justify"">(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and</p><p align=""justify"">(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17098_17071_R","Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient","AUTHORITY_REQUIRED","17071","17098","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p>Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application.</p> <p>Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:</p><p align=""justify"">(a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or</p><p align=""justify"">(b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy</p><p align=""justify"">Provide in this authority application, and document in the patient&apos;s medical records, each of:</p><p align=""justify"">(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;</p><p align=""justify"">(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);</p><p align=""justify"">(iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled;</p><p align=""justify"">(iv) the dates that response assessments were determined.</p><p align=""justify"">Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment:</p><p align=""justify"">(v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);</p><p align=""justify"">(vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p>Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application.</p> <p>Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:</p><p align=""justify"">(a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or</p><p align=""justify"">(b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy</p><p align=""justify"">Provide in this authority application, and document in the patient&apos;s medical records, each of:</p><p align=""justify"">(i) the name of each prior therapy trialled that meets the above requirements - state at least 2;</p><p align=""justify"">(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);</p><p align=""justify"">(iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled;</p><p align=""justify"">(iv) the dates that response assessments were determined.</p><p align=""justify"">Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment:</p><p align=""justify"">(v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);</p><p align=""justify"">(vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-09-01","Y","4708"
"17100_17000_R","Subsequent continuing treatment (Face, hand, foot)","AUTHORITY_REQUIRED","17000","17100","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment (Face, hand, foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment (Face, hand, foot) - treatment covering week 28 and onwards restrictions; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""left"">The assessment of response to treatment must be provided in this application and documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment (Face, hand, foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment (Face, hand, foot) - treatment covering week 28 and onwards restrictions; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""left"">The assessment of response to treatment must be provided in this application and documented in the patient&apos;s medical records.</p>","N","N","N","FULL","ALL","N","2025-09-01","Y","4708"
"17101_17085_R","Continuing treatment","STREAMLINED","17085","17101","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.</p><p align=""justify"">Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) If applicable, the baseline and maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or</p><p align=""justify"">(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and</p><p align=""justify"">(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised dose of this biological medicine so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab.</p><p align=""justify"">Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">At the time of authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks therapy.</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) If applicable, the baseline and maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or</p><p align=""justify"">(c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and</p><p align=""justify"">(d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced.</p><p align=""justify"">The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17103_17104_R","First continuing treatment of Crohn disease in a paediatric patient","AUTHORITY_REQUIRED","17104","17103","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>First continuing treatment of Crohn disease in a paediatric patient</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have both: (i) a total PCDAI score of 40 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; or</p> <p>Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The assessment of response must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.</p> <p align=""left"">Authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction for patients who:</p><p align=""left"">(i) received fewer than 5 repeats at the time of application; and/or</p><p align=""left"">(ii) required changes to their dosing regimen during this treatment phase.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>First continuing treatment of Crohn disease in a paediatric patient</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have both: (i) a total PCDAI score of 40 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; or</p> <p>Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The assessment of response must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.</p> <p align=""left"">Authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction for patients who:</p><p align=""left"">(i) received fewer than 5 repeats at the time of application; and/or</p><p align=""left"">(ii) required changes to their dosing regimen during this treatment phase.</p>","N","N","N","FULL","ALL","N","2025-09-01","Y","4708"
"17108_17108_R","null","STREAMLINED","17108","17108","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Must be treated in an accredited treatment centre; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child-bearing age; AND</p> <p>Patient must have compensated liver disease; AND</p> <p>Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND</p> <p>Patient must have a contraindication to ribavirin; AND</p> <p>The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND</p> <p>The treatment must be limited to a maximum duration of 48 weeks.</p> <p align=""justify"">Evidence of chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.</p> <p>Chronic hepatitis C infection</p><br/><p>Must be treated in an accredited treatment centre; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child-bearing age; AND</p> <p>Patient must have compensated liver disease; AND</p> <p>Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND</p> <p>Patient must have a contraindication to ribavirin; AND</p> <p>The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND</p> <p>The treatment must be limited to a maximum duration of 48 weeks.</p> <p align=""justify"">Evidence of chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient&apos;s medical records.</p> <p align=""left"">Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for hepatitis C:</p><p align=""left"">(a) a nurse educator/counsellor for patients; and</p><p align=""left"">(b) 24-hour access by patients to medical advice; and</p><p align=""left"">(c) an established liver clinic.</p>","N","N","N","IMMEDIATE","ALL","N","2025-09-01","N","4708"
"17109_17113_R","Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements","AUTHORITY_REQUIRED","17113","17109","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 September 2025; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist; (iv) paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by at least one of the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility, (ii) airway hyperresponsiveness, (iii) peak expiratory flow (PEF) variability; AND</p> <p>Patient must have had a duration of asthma of at least 1 year prior to commencement of non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have had a documented total serum human immunoglobulin E of at least 30 IU/mL measured no more than 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition, with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE no more than 12 months prior to initiation of PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre in the 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have had a fractional exhaled nitric oxide of at least 20 ppb in the 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have documented a failure to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment with this drug if the patient has received at least 28 weeks of treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must have been aged 6 to less than 12 years prior to starting non-PBS-subsidised treatment with this drug.</p> <p align=""justify"">Optimised asthma therapy includes:</p><p align=""justify"">(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;</p><p align=""justify"">AND</p><p align=""justify"">(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control with optimised asthma therapy and must be demonstrated in all patients at the time of the application:<br/>(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed prior to non-PBS-subsidised treatment with this drug for this condition (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used), <br/>AND<br/>(b) while receiving optimised asthma therapy in the prior to non-PBS-subsidised treatment with this drug for this condition 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate to determine whether the patient has achieved or sustained an adequate response to non-PBS subsidised treatment, must be conducted immediately (no later than 4 weeks after the last dose of non-PBS-subsidised treatment) prior to this application if the treatment duration has been at least 28 weeks</p><p align=""justify"">All applications for continuing treatment with this biological medicine must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate must be made at around 20 weeks after the first dose of PBS-subsidised treatment with this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.</p><p align=""justify"">The first assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date of the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of dupilumab, sufficient for 24 weeks of therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) prior optimised asthma drug therapy (date of commencement and duration of therapy); and</p><p align=""justify"">(b) IgE, blood eosinophils or fractional exhaled nitric oxide results and date from prior to initiating non-PBS-subsidised treatment with this drug; and</p><p align=""justify"">(c) date of commencing non-PBS-subsidised treatment with this drug for this condition.</p><p align=""justify"">(d) If applicable, maintenance oral corticosteroid dose; and</p><p align=""justify"">(e) If applicable, the Asthma Control Questionnaire (ACQ-5) scores, including the date of assessment of the patient&apos;s symptoms; or</p><p align=""justify"">(f) If applicable, the Asthma Control Questionnaire interviewer administered version (ACQ-IA) scores, including the date of assessment of the patient&apos;s symptoms.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 September 2025; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist; (iv) paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by at least one of the following standard clinical features: (i) forced expiratory volume (FEV1) reversibility, (ii) airway hyperresponsiveness, (iii) peak expiratory flow (PEF) variability; AND</p> <p>Patient must have had a duration of asthma of at least 1 year prior to commencement of non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have had a documented total serum human immunoglobulin E of at least 30 IU/mL measured no more than 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition, with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE no more than 12 months prior to initiation of PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre in the 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have had a fractional exhaled nitric oxide of at least 20 ppb in the 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have documented a failure to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment with this drug if the patient has received at least 28 weeks of treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must have been aged 6 to less than 12 years prior to starting non-PBS-subsidised treatment with this drug.</p> <p align=""justify"">Optimised asthma therapy includes:</p><p align=""justify"">(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;</p><p align=""justify"">AND</p><p align=""justify"">(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score of at least 0.5 from baseline, OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score from baseline, OR</p><p align=""justify"">(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control with optimised asthma therapy and must be demonstrated in all patients at the time of the application:<br/>(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed prior to non-PBS-subsidised treatment with this drug for this condition (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used), <br/>AND<br/>(b) while receiving optimised asthma therapy in the prior to non-PBS-subsidised treatment with this drug for this condition 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate to determine whether the patient has achieved or sustained an adequate response to non-PBS subsidised treatment, must be conducted immediately (no later than 4 weeks after the last dose of non-PBS-subsidised treatment) prior to this application if the treatment duration has been at least 28 weeks</p><p align=""justify"">All applications for continuing treatment with this biological medicine must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient&apos;s response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate must be made at around 20 weeks after the first dose of PBS-subsidised treatment with this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.</p><p align=""justify"">The first assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this drug for this condition.</p><p align=""justify"">A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date of the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of dupilumab, sufficient for 24 weeks of therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) prior optimised asthma drug therapy (date of commencement and duration of therapy); and</p><p align=""justify"">(b) IgE, blood eosinophils or fractional exhaled nitric oxide results and date from prior to initiating non-PBS-subsidised treatment with this drug; and</p><p align=""justify"">(c) date of commencing non-PBS-subsidised treatment with this drug for this condition.</p><p align=""justify"">(d) If applicable, maintenance oral corticosteroid dose; and</p><p align=""justify"">(e) If applicable, the Asthma Control Questionnaire (ACQ-5) scores, including the date of assessment of the patient&apos;s symptoms; or</p><p align=""justify"">(f) If applicable, the Asthma Control Questionnaire interviewer administered version (ACQ-IA) scores, including the date of assessment of the patient&apos;s symptoms.</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the accepted toxicities, including severity, which will be accepted for the purposes of exempting a patient from the requirement of treatment with optimised asthma therapy.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","FULL","ALL","N","2025-09-01","Y","4708"
"17121_17122_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","17122","17121","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have both: (i) a total PCDAI score of 30 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; or</p> <p>Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The assessment of response must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Each application for subsequent continuing treatment with this drug must include an assessment of the patient&apos;s response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">Authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction for patients who:</p><p align=""justify"">(i) received fewer than 2 repeats at the time of application; and/or</p><p align=""justify"">(ii) required changes to their dosing regimen during this treatment phase.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have both: (i) a total PCDAI score of 30 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; or</p> <p>Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The assessment of response must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Each application for subsequent continuing treatment with this drug must include an assessment of the patient&apos;s response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">Authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction for patients who:</p><p align=""justify"">(i) received fewer than 2 repeats at the time of application; and/or</p><p align=""justify"">(ii) required changes to their dosing regimen during this treatment phase.</p>","N","N","N","FULL","ALL","N","2025-09-01","Y","4708"
"17129_17395_R","Continuing treatment","STREAMLINED","17395","17129","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proliferative diabetic retinopathy (PDR) and/or Diabetic macular oedema (DMO)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proliferative diabetic retinopathy (PDR) and/or Diabetic macular oedema (DMO)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17130_17288_R","Initial treatment","AUTHORITY_REQUIRED","17288","17130","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proliferative diabetic retinopathy (PDR) and/or Diabetic macular oedema (DMO)</p><br/><p>Initial treatment</p><br/><p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment. This is only a requirement for patients being treated for DMO; AND</p> <p>The condition must be diagnosed by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; or</p> <p>The condition must be diagnosed by retinal photography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this indication for the same eye; AND</p> <p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">Details (date, unique identifying number/code or provider number) of one of the following diagnostic reports for each eye must be documented in the patient&apos;s medical records:</p><p align=""justify"">(i) fluorescein angiogram report;</p><p align=""justify"">(ii) optical coherence tomography report;</p><p align=""justify"">(iii) retinal photography report.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proliferative diabetic retinopathy (PDR) and/or Diabetic macular oedema (DMO)</p><br/><p>Initial treatment</p><br/><p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment. This is only a requirement for patients being treated for DMO; AND</p> <p>The condition must be diagnosed by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; or</p> <p>The condition must be diagnosed by retinal photography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this indication for the same eye; AND</p> <p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">Details (date, unique identifying number/code or provider number) of one of the following diagnostic reports for each eye must be documented in the patient&apos;s medical records:</p><p align=""justify"">(i) fluorescein angiogram report;</p><p align=""justify"">(ii) optical coherence tomography report;</p><p align=""justify"">(iii) retinal photography report.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17131_17289_R","Initial treatment","AUTHORITY_REQUIRED","17289","17131","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetic macular oedema (DMO)</p><br/><p>Initial treatment</p><br/><p>Patient must have visual impairment due to diabetic macular oedema; AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">Details (date, unique identifying number/code or provider number) of one of the following diagnostic reports for each eye must be documented in the patient&apos;s medical records:</p><p align=""justify"">(i) fluorescein angiogram report;</p><p align=""justify"">(ii) optical coherence tomography report.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetic macular oedema (DMO)</p><br/><p>Initial treatment</p><br/><p>Patient must have visual impairment due to diabetic macular oedema; AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">Details (date, unique identifying number/code or provider number) of one of the following diagnostic reports for each eye must be documented in the patient&apos;s medical records:</p><p align=""justify"">(i) fluorescein angiogram report;</p><p align=""justify"">(ii) optical coherence tomography report.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17132_17387_R","Initial treatment","AUTHORITY_REQUIRED","17387","17132","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetic macular oedema (DMO)</p><br/><p>Initial treatment</p><br/><p>Patient must have visual impairment due to diabetic macular oedema; AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>Patient must have had a cataract removed in the treated eye; or</p> <p>Patient must be scheduled for cataract surgery in the treated eye; AND</p> <p>Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; or</p> <p>Patient must be unsuitable for treatment with VEGF inhibitors; or</p> <p>Patient must have failed prior treatment with VEGF inhibitors; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">Details (date, unique identifying number/code or provider number) of one of the following diagnostic reports for each eye must be documented in the patient&apos;s medical records:</p><p align=""justify"">(i) fluorescein angiogram report;</p><p align=""justify"">(ii) optical coherence tomography report.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetic macular oedema (DMO)</p><br/><p>Initial treatment</p><br/><p>Patient must have visual impairment due to diabetic macular oedema; AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>Patient must have had a cataract removed in the treated eye; or</p> <p>Patient must be scheduled for cataract surgery in the treated eye; AND</p> <p>Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; or</p> <p>Patient must be unsuitable for treatment with VEGF inhibitors; or</p> <p>Patient must have failed prior treatment with VEGF inhibitors; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">Details (date, unique identifying number/code or provider number) of one of the following diagnostic reports for each eye must be documented in the patient&apos;s medical records:</p><p align=""justify"">(i) fluorescein angiogram report;</p><p align=""justify"">(ii) optical coherence tomography report.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17133_17167_R","Recommencement of treatment","AUTHORITY_REQUIRED","17167","17133","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a chronological age of 5 years or greater; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a chronological age of 5 years or greater; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17134_17298_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17298","17134","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had an intracranial lesion which is under appropriate observation and management; or</p> <p>Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR</p><p align=""justify"">(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had an intracranial lesion which is under appropriate observation and management; or</p> <p>Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR</p><p align=""justify"">(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17135_17151_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17151","17135","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must not have a bone age of 13.5 years or greater.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. A height measurement from immediately prior to commencement of growth hormone treatment; AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND</p><p align=""justify"">5. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must not have a bone age of 13.5 years or greater.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. A height measurement from immediately prior to commencement of growth hormone treatment; AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND</p><p align=""justify"">5. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17138_17162_R","Recommencement of treatment","AUTHORITY_REQUIRED","17162","17138","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17139_17293_R","Recommencement of treatment","AUTHORITY_REQUIRED","17293","17139","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17140_17166_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17166","17140","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; or</p> <p>Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; or</p> <p>Patient must be female and menarche occurred before the chronological age of 10 years; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. Confirmation that the patient has precocious puberty; AND</p><p align=""justify"">4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; or</p> <p>Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; or</p> <p>Patient must be female and menarche occurred before the chronological age of 10 years; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. Confirmation that the patient has precocious puberty; AND</p><p align=""justify"">4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17145_17142_R","Recommencement of treatment","AUTHORITY_REQUIRED","17142","17145","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17146_17296_R","Recommencement of treatment","AUTHORITY_REQUIRED","17296","17146","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND</p> <p>Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">If a patient receiving treatment under the indication &apos;short stature associated with chronic renal insufficiency&apos; undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m<sup>2</sup> prescribers should seek reclassification to the indication short stature and slow growth.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND</p> <p>Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">If a patient receiving treatment under the indication &apos;short stature associated with chronic renal insufficiency&apos; undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m<sup>2</sup> prescribers should seek reclassification to the indication short stature and slow growth.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17147_17295_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17295","17147","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If a patient receiving treatment under the indication short stature due to chronic renal insufficiency undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m<sup>2</sup> prescribers should seek reclassification to the indication short stature and slow growth.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17150_17160_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17160","17150","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have a structural lesion that is not neoplastic; or</p> <p>Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); or</p> <p>Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p> <p>Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND</p> <p>Patient must have hypothalamic obesity; AND</p> <p>Patient must have had a growth velocity above the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR</p><p align=""justify"">(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR</p><p align=""justify"">(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p><p align=""justify"">6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND</p><p align=""justify"">7. Confirmation that the patient has hypothalamic obesity; AND</p><p align=""justify"">8. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">9. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have a structural lesion that is not neoplastic; or</p> <p>Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); or</p> <p>Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p> <p>Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND</p> <p>Patient must have hypothalamic obesity; AND</p> <p>Patient must have had a growth velocity above the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR</p><p align=""justify"">(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR</p><p align=""justify"">(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p><p align=""justify"">6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND</p><p align=""justify"">7. Confirmation that the patient has hypothalamic obesity; AND</p><p align=""justify"">8. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">9. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17152_17332_R","Recommencement of treatment","AUTHORITY_REQUIRED","17332","17152","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17153_17176_R","Recommencement of treatment","AUTHORITY_REQUIRED","17176","17153","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17156_17171_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17171","17156","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and poor body composition due to Prader-Willi syndrome</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature and poor body composition due to Prader-Willi syndrome; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with Prader-Willi syndrome (the condition must be genetically proven); or</p> <p>Patient must have a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment and any sleep disorders identified that required treatment must have been addressed; or</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with no sleep disorders identified; or</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified which are not of sufficient severity to require treatment; or</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified for which the patient is currently receiving ameliorative treatment; AND</p> <p>Patient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient''s current height; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a chronological age of 18 years or greater; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) Confirmation that the patient has diagnostic results consistent with Prader-Willi syndrome, OR</p><p align=""justify"">(b) Confirmation that the patient has a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND</p><p align=""justify"">4. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment or within the last 12 months, and any sleep disorders identified via the polysomnography that required treatment have been addressed; AND</p><p align=""justify"">5. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">6. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and poor body composition due to Prader-Willi syndrome</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature and poor body composition due to Prader-Willi syndrome; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with Prader-Willi syndrome (the condition must be genetically proven); or</p> <p>Patient must have a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment and any sleep disorders identified that required treatment must have been addressed; or</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with no sleep disorders identified; or</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified which are not of sufficient severity to require treatment; or</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified for which the patient is currently receiving ameliorative treatment; AND</p> <p>Patient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient''s current height; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a chronological age of 18 years or greater; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) Confirmation that the patient has diagnostic results consistent with Prader-Willi syndrome, OR</p><p align=""justify"">(b) Confirmation that the patient has a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND</p><p align=""justify"">4. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment or within the last 12 months, and any sleep disorders identified via the polysomnography that required treatment have been addressed; AND</p><p align=""justify"">5. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">6. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17159_17141_R","Recommencement of treatment","AUTHORITY_REQUIRED","17141","17159","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17161_17292_R","Recommencement of treatment","AUTHORITY_REQUIRED","17292","17161","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17163_17144_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17144","17163","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have a chronological age of less than 2 years; AND</p> <p>Patient must have a documented clinical risk of hypoglycaemia; AND</p> <p>Patient must have documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. Confirmation that the patient has a documented clinical risk of hypoglycaemia; AND</p><p align=""justify"">4. Confirmation that the patient has documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND</p><p align=""justify"">5. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have a chronological age of less than 2 years; AND</p> <p>Patient must have a documented clinical risk of hypoglycaemia; AND</p> <p>Patient must have documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. Confirmation that the patient has a documented clinical risk of hypoglycaemia; AND</p><p align=""justify"">4. Confirmation that the patient has documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND</p><p align=""justify"">5. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17164_17136_R","Recommencement of treatment","AUTHORITY_REQUIRED","17136","17164","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17165_17157_R","Recommencement of treatment","AUTHORITY_REQUIRED","17157","17165","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and poor body composition due to Prader-Willi syndrome</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and poor body composition due to Prader Willi syndrome category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies); or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies), unless response was affected by a significant medical illness; or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have been re-evaluated via polysomnography for airway obstruction and apnoea during the initial 32 week treatment period and any sleep disorders identified that required treatment must have been addressed; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have developed uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient''s current height; AND</p> <p>Patient must not have a chronological age of equal to or greater than 18 years; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height, weight, and waist circumference, not older than three months); AND</p><p align=""justify"">4. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity.]; AND</p><p align=""justify"">5. Confirmation that during the initial 32 week treatment period, the patient was re-evaluated via polysomnography for airway obstruction and apnoea, and any sleep disorders that were identified have been addressed; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and poor body composition due to Prader-Willi syndrome</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and poor body composition due to Prader Willi syndrome category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies); or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies), unless response was affected by a significant medical illness; or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have been re-evaluated via polysomnography for airway obstruction and apnoea during the initial 32 week treatment period and any sleep disorders identified that required treatment must have been addressed; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have developed uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient''s current height; AND</p> <p>Patient must not have a chronological age of equal to or greater than 18 years; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height, weight, and waist circumference, not older than three months); AND</p><p align=""justify"">4. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity.]; AND</p><p align=""justify"">5. Confirmation that during the initial 32 week treatment period, the patient was re-evaluated via polysomnography for airway obstruction and apnoea, and any sleep disorders that were identified have been addressed; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17169_17137_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17137","17169","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; or</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both: (i) a height no higher than the 1st percentile for age plus sex at the time of having commenced treatment with this drug, (ii) over the 12 month interval immediately prior to having commenced treatment, a growth velocity no greater than 8 cm/year where the patient had a bone/chronological age of no greater than 2.5 years; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (where the patient&apos;s chronological age was higher than 2.5 years); OR</p><p align=""justify"">(b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m<sup>2</sup> measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND</p><p align=""justify"">4. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">5. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of the growth hormone requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; or</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both: (i) a height no higher than the 1st percentile for age plus sex at the time of having commenced treatment with this drug, (ii) over the 12 month interval immediately prior to having commenced treatment, a growth velocity no greater than 8 cm/year where the patient had a bone/chronological age of no greater than 2.5 years; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (where the patient&apos;s chronological age was higher than 2.5 years); OR</p><p align=""justify"">(b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m<sup>2</sup> measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND</p><p align=""justify"">4. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">5. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of the growth hormone requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17170_17158_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17158","17170","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND</p><p align=""justify"">5. If the patient&apos;s condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient&apos;s increased risk of gonadoblastoma is in place; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND</p><p align=""justify"">5. If the patient&apos;s condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient&apos;s increased risk of gonadoblastoma is in place; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17172_17143_R","Recommencement of treatment","AUTHORITY_REQUIRED","17143","17172","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17173_17301_R","Recommencement of treatment","AUTHORITY_REQUIRED","17301","17173","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17174_17175_R","Recommencement of treatment","AUTHORITY_REQUIRED","17175","17174","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17177_17154_R","Recommencement of treatment","AUTHORITY_REQUIRED","17154","17177","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17178_17155_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17155","17178","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); or</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR</p><p align=""justify"">(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">6. A bone age result performed within the last 12 months; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); or</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR</p><p align=""justify"">(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">6. A bone age result performed within the last 12 months; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17181_17300_R","Recommencement of treatment","AUTHORITY_REQUIRED","17300","17181","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17183_17226_R","Continuing treatment","AUTHORITY_REQUIRED","17226","17183","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a chronological age of 5 years or greater.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">When a patient receiving treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants reaches or surpasses 5 years of age (chronological), prescribers should seek reclassification to the indication &apos;short stature due to biochemical growth hormone deficiency&apos;.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a chronological age of 5 years or greater.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">When a patient receiving treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants reaches or surpasses 5 years of age (chronological), prescribers should seek reclassification to the indication &apos;short stature due to biochemical growth hormone deficiency&apos;.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17184_17188_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17188","17184","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had an intracranial lesion which is under appropriate observation and management; or</p> <p>Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR</p><p align=""justify"">(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had an intracranial lesion which is under appropriate observation and management; or</p> <p>Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR</p><p align=""justify"">(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17185_17305_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17305","17185","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have a structural lesion that is not neoplastic; or</p> <p>Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); or</p> <p>Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND</p> <p>Patient must have hypothalamic obesity; AND</p> <p>Patient must have had a growth velocity above the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR</p><p align=""justify"">(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR</p><p align=""justify"">(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p><p align=""justify"">6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND</p><p align=""justify"">7. Confirmation that the patient has hypothalamic obesity; AND</p><p align=""justify"">8. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">9. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have a structural lesion that is not neoplastic; or</p> <p>Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); or</p> <p>Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND</p> <p>Patient must have hypothalamic obesity; AND</p> <p>Patient must have had a growth velocity above the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR</p><p align=""justify"">(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR</p><p align=""justify"">(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p><p align=""justify"">6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND</p><p align=""justify"">7. Confirmation that the patient has hypothalamic obesity; AND</p><p align=""justify"">8. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">9. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17191_17206_R","Continuing treatment","AUTHORITY_REQUIRED","17206","17191","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17192_17232_R","Continuing treatment","AUTHORITY_REQUIRED","17232","17192","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND</p> <p>Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND</p> <p>Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If a patient receiving treatment under the indication short stature due to chronic renal insufficiency undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m<sup>2</sup> prescribers should seek reclassification to the indication short stature and slow growth.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17193_17306_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17306","17193","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; or</p> <p>Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; or</p> <p>Patient must be female and menarche occurred before the chronological age of 10 years; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. Confirmation that the patient has precocious puberty; AND</p><p align=""justify"">4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; or</p> <p>Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; or</p> <p>Patient must be female and menarche occurred before the chronological age of 10 years; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. Confirmation that the patient has precocious puberty; AND</p><p align=""justify"">4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17194_17231_R","Change of drug","AUTHORITY_REQUIRED","17231","17194","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Change of drug</p><br/><p>Patient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication; AND</p> <p>Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Definition:</p><p align=""justify"">An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:</p><p align=""justify"">(a) the 50<sup>th</sup> percentile growth velocity for bone age;</p><p align=""justify"">(b) an increase in height standard deviation score for chronological age;</p><p align=""justify"">(c) a minimum growth velocity of 4 cm per year;</p><p align=""justify"">(d) a mid-parental height standard deviation score.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""justify"">Where growth data has been supplied within 3 months of this authority application, do not resupply this data.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Change of drug</p><br/><p>Patient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication; AND</p> <p>Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Definition:</p><p align=""justify"">An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:</p><p align=""justify"">(a) the 50<sup>th</sup> percentile growth velocity for bone age;</p><p align=""justify"">(b) an increase in height standard deviation score for chronological age;</p><p align=""justify"">(c) a minimum growth velocity of 4 cm per year;</p><p align=""justify"">(d) a mid-parental height standard deviation score.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""justify"">Where growth data has been supplied within 3 months of this authority application, do not resupply this data.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) that facilitates approximately 13 weeks of treatment per dispensing. Request up to 1 repeat prescription. With 1 repeat prescription, this treatment phase listing intends to provide approximately 26 weeks of treatment.</p><p align=""justify"">An online calculator has been developed to assist in the determination of the quantity of drug to be sought. It is located in the following location:</p><p align=""justify"">https://www.pbs.gov.au/browse/section100-gh</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17198_17207_R","Continuing treatment","AUTHORITY_REQUIRED","17207","17198","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17199_17197_R","Change of drug","AUTHORITY_REQUIRED","17197","17199","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Change of drug</p><br/><p>Patient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication; AND</p> <p>Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Definition:</p><p align=""justify"">An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:</p><p align=""justify"">(a) the 50<sup>th</sup> percentile growth velocity for bone age;</p><p align=""justify"">(b) an increase in height standard deviation score for chronological age;</p><p align=""justify"">(c) a minimum growth velocity of 4 cm per year;</p><p align=""justify"">(d) a mid-parental height standard deviation score.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""justify"">Where growth data has been supplied within 3 months of this authority application, do not resupply this data.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Change of drug</p><br/><p>Patient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication; AND</p> <p>Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Definition:</p><p align=""justify"">An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:</p><p align=""justify"">(a) the 50<sup>th</sup> percentile growth velocity for bone age;</p><p align=""justify"">(b) an increase in height standard deviation score for chronological age;</p><p align=""justify"">(c) a minimum growth velocity of 4 cm per year;</p><p align=""justify"">(d) a mid-parental height standard deviation score.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""justify"">Where growth data has been supplied within 3 months of this authority application, do not resupply this data.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) that facilitates approximately 13 weeks of treatment per dispensing. Request up to 1 repeat prescription. With 1 repeat prescription, this treatment phase listing intends to provide approximately 26 weeks of treatment.</p><p align=""justify"">An online calculator has been developed to assist in the determination of the quantity of drug to be sought. It is located in the following location:</p><p align=""justify"">https://www.pbs.gov.au/browse/section100-gh</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17201_17202_R","Continuing treatment","AUTHORITY_REQUIRED","17202","17201","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17204_17186_R","Continuing treatment","AUTHORITY_REQUIRED","17186","17204","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17205_17187_R","Continuing treatment","AUTHORITY_REQUIRED","17187","17205","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND</p> <p>Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND</p> <p>Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17208_17210_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17210","17208","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); or</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age and sex immediately prior to commencing treatment; OR</p><p align=""justify"">(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); or</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age and sex immediately prior to commencing treatment; OR</p><p align=""justify"">(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17209_17190_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17190","17209","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Confirmation that the patient has an estimated glomerular filtration rate less than 30ml/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Confirmation that the patient has an estimated glomerular filtration rate less than 30ml/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If a patient receiving treatment under the indication short stature due to chronic renal insufficiency undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m<sup>2</sup> prescribers should seek reclassification to the indication short stature and slow growth.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17211_17238_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17238","17211","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND</p><p align=""justify"">5. If the patient&apos;s condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient&apos;s increased risk of gonadoblastoma is in place; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND</p><p align=""justify"">5. If the patient&apos;s condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient&apos;s increased risk of gonadoblastoma is in place; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17215_17219_R","Continuing treatment","AUTHORITY_REQUIRED","17219","17215","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and poor body composition due to Prader-Willi syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and poor body composition due to Prader-Willi syndrome category; AND</p> <p>Patient must have been re-evaluated via polysomnography for airway obstruction and apnoea during the initial 32 week treatment period and any sleep disorders identified that required treatment must have been addressed; AND</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved height percentile for age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved body mass index SDS for age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved waist circumference while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved waist/height ratio (waist circumference in centimetres divided by height in centimetres) while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have achieved an increase in height percentile with reference to the untreated Prader-Willi syndrome standards for age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must not have been on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved body mass index while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved body mass index SDS for age and sex while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved waist circumference while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved waist/height ratio (waist circumference in centimetres divided by height in centimetres) while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved weight SDS for age and sex while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have developed uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient''s current height; AND</p> <p>Patient must not have a chronological age of equal to or greater than 18 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""left"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""left"">3. Growth data (height, weight and waist circumference) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""left"">4. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND</p><p align=""justify"">5. Confirmation that during the initial 32 week treatment period, the patient was re-evaluated via polysomnography for airway obstruction and apnoea, and any sleep disorders that were identified have been addressed; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p>Maintenance is defined as a value within a 5% tolerance (this allows for seasonal and other measurement variations).</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and poor body composition due to Prader-Willi syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and poor body composition due to Prader-Willi syndrome category; AND</p> <p>Patient must have been re-evaluated via polysomnography for airway obstruction and apnoea during the initial 32 week treatment period and any sleep disorders identified that required treatment must have been addressed; AND</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved height percentile for age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved body mass index SDS for age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved waist circumference while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved waist/height ratio (waist circumference in centimetres divided by height in centimetres) while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have achieved an increase in height percentile with reference to the untreated Prader-Willi syndrome standards for age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must not have been on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved body mass index while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved body mass index SDS for age and sex while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved waist circumference while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved waist/height ratio (waist circumference in centimetres divided by height in centimetres) while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved weight SDS for age and sex while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have developed uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient''s current height; AND</p> <p>Patient must not have a chronological age of equal to or greater than 18 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""left"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""left"">3. Growth data (height, weight and waist circumference) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""left"">4. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND</p><p align=""justify"">5. Confirmation that during the initial 32 week treatment period, the patient was re-evaluated via polysomnography for airway obstruction and apnoea, and any sleep disorders that were identified have been addressed; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p>Maintenance is defined as a value within a 5% tolerance (this allows for seasonal and other measurement variations).</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17216_17227_R","Continuing treatment","AUTHORITY_REQUIRED","17227","17216","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND</p> <p>Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an annualised growth velocity for bone age at or above the mean growth velocity for untreated Turner Syndrome girls (using the Turner Syndrome - Ranke growth velocity chart) while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a bone age of 13.5 years or greater; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND</p> <p>Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an annualised growth velocity for bone age at or above the mean growth velocity for untreated Turner Syndrome girls (using the Turner Syndrome - Ranke growth velocity chart) while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a bone age of 13.5 years or greater; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17217_17203_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17203","17217","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a bone age of 13.5 years or greater; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. A height measurement from immediately prior to commencement of growth hormone treatment; AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND</p><p align=""justify"">5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a bone age of 13.5 years or greater; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. A height measurement from immediately prior to commencement of growth hormone treatment; AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND</p><p align=""justify"">5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17218_17200_R","Continuing treatment","AUTHORITY_REQUIRED","17200","17218","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17221_17220_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17220","17221","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND</p><p align=""justify"">5. If the patient&apos;s condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient&apos;s increased risk of gonadoblastoma is in place; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND</p><p align=""justify"">5. If the patient&apos;s condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient&apos;s increased risk of gonadoblastoma is in place; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17223_17195_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17195","17223","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; or</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both: (i) a height no higher than the 1st percentile for age plus sex at the time of having commenced treatment with this drug, (ii) over the 12 month interval immediately prior to having commenced treatment, a growth velocity no greater than 8 cm/year where the patient had a bone/chronological age of no greater than 2.5 years; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (where the patient&apos;s chronological age was higher than 2.5 years); OR</p><p align=""justify"">(b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m<sup>2</sup> measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND</p><p align=""justify"">4. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">5. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; or</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both: (i) a height no higher than the 1st percentile for age plus sex at the time of having commenced treatment with this drug, (ii) over the 12 month interval immediately prior to having commenced treatment, a growth velocity no greater than 8 cm/year where the patient had a bone/chronological age of no greater than 2.5 years; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (where the patient&apos;s chronological age was higher than 2.5 years); OR</p><p align=""justify"">(b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m<sup>2</sup> measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND</p><p align=""justify"">4. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">5. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17224_17189_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17189","17224","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have a chronological age of less than 2 years; AND</p> <p>Patient must have a documented clinical risk of hypoglycaemia; AND</p> <p>Patient must have documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. Confirmation that the patient has a documented clinical risk of hypoglycaemia; AND</p><p align=""justify"">4. Confirmation that the patient has documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND</p><p align=""justify"">5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have a chronological age of less than 2 years; AND</p> <p>Patient must have a documented clinical risk of hypoglycaemia; AND</p> <p>Patient must have documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. Confirmation that the patient has a documented clinical risk of hypoglycaemia; AND</p><p align=""justify"">4. Confirmation that the patient has documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND</p><p align=""justify"">5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17225_17196_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17196","17225","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Confirmation that the patient has an estimated glomerular filtration rate less than 30ml/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Confirmation that the patient has an estimated glomerular filtration rate less than 30ml/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If a patient receiving treatment under the indication short stature due to chronic renal insufficiency undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m<sup>2</sup> prescribers should seek reclassification to the indication short stature and slow growth.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17228_17213_R","Continuing treatment","AUTHORITY_REQUIRED","17213","17228","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17233_17222_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17222","17233","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and poor body composition due to Prader-Willi syndrome</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature and poor body composition due to Prader-Willi syndrome; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with Prader-Willi syndrome (the condition must be genetically proven); or</p> <p>Patient must have a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment and any sleep disorders identified that required treatment must have been addressed; AND</p> <p>Patient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient''s current height; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a chronological age of 18 years or greater; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) Confirmation that the patient has diagnostic results consistent with Prader-Willi syndrome, OR</p><p align=""justify"">(b) Confirmation that the patient has a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND</p><p align=""justify"">4. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment, and any sleep disorders identified via the polysomnography that required treatment have been addressed; AND</p><p align=""justify"">5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">6. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and poor body composition due to Prader-Willi syndrome</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature and poor body composition due to Prader-Willi syndrome; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with Prader-Willi syndrome (the condition must be genetically proven); or</p> <p>Patient must have a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment and any sleep disorders identified that required treatment must have been addressed; AND</p> <p>Patient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient''s current height; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a chronological age of 18 years or greater; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) Confirmation that the patient has diagnostic results consistent with Prader-Willi syndrome, OR</p><p align=""justify"">(b) Confirmation that the patient has a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND</p><p align=""justify"">4. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment, and any sleep disorders identified via the polysomnography that required treatment have been addressed; AND</p><p align=""justify"">5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">6. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17234_17307_R","Continuing treatment","AUTHORITY_REQUIRED","17307","17234","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND</p> <p>Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND</p> <p>Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17235_17229_R","Continuing treatment","AUTHORITY_REQUIRED","17229","17235","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17236_17237_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17237","17236","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; or</p> <p>Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; or</p> <p>Patient must be female and menarche occurred before the chronological age of 10 years; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. Confirmation that the patient has precocious puberty; AND</p><p align=""justify"">4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; or</p> <p>Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; or</p> <p>Patient must be female and menarche occurred before the chronological age of 10 years; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. Confirmation that the patient has precocious puberty; AND</p><p align=""justify"">4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17239_17256_R","Initial treatment","AUTHORITY_REQUIRED","17256","17239","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must have a chronological age of less than 2 years; AND</p> <p>Patient must have a documented clinical risk of hypoglycaemia; AND</p> <p>Patient must have documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. Confirmation that the patient has a documented clinical risk of hypoglycaemia; AND</p><p align=""justify"">5. Confirmation that the patient has documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must have a chronological age of less than 2 years; AND</p> <p>Patient must have a documented clinical risk of hypoglycaemia; AND</p> <p>Patient must have documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. Confirmation that the patient has a documented clinical risk of hypoglycaemia; AND</p><p align=""justify"">5. Confirmation that the patient has documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17240_17242_R","Initial treatment","AUTHORITY_REQUIRED","17242","17240","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Initial treatment</p><br/><p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; AND</p> <p>Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND</p><p align=""justify"">6. If the patient&apos;s condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient&apos;s increased risk of gonadoblastoma is in place; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Initial treatment</p><br/><p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; AND</p> <p>Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND</p><p align=""justify"">6. If the patient&apos;s condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient&apos;s increased risk of gonadoblastoma is in place; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17243_17255_R","Initial treatment","AUTHORITY_REQUIRED","17255","17243","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Initial treatment</p><br/><p>Patient must have a current height at or below the 1st percentile for age and sex; AND</p> <p>Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 160.1 cm; or</p> <p>Patient must be female and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 148.0 cm; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation of the patient&apos;s maturational or constitutional delay status; AND</p><p align=""justify"">6. If the patient has maturational or constitutional delay, confirmation that the patient has an estimated mature height below the 1<sup>st</sup> adult height percentile; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Initial treatment</p><br/><p>Patient must have a current height at or below the 1st percentile for age and sex; AND</p> <p>Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 160.1 cm; or</p> <p>Patient must be female and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 148.0 cm; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation of the patient&apos;s maturational or constitutional delay status; AND</p><p align=""justify"">6. If the patient has maturational or constitutional delay, confirmation that the patient has an estimated mature height below the 1<sup>st</sup> adult height percentile; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17244_17252_R","Initial treatment","AUTHORITY_REQUIRED","17252","17244","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17245_17259_R","Initial treatment","AUTHORITY_REQUIRED","17259","17245","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Initial treatment</p><br/><p>Patient must have had an intracranial lesion which is under appropriate observation and management; or</p> <p>Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st percentile for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st percentile for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have a current height above the 1st percentile for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR</p><p align=""justify"">(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Initial treatment</p><br/><p>Patient must have had an intracranial lesion which is under appropriate observation and management; or</p> <p>Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st percentile for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st percentile for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have a current height above the 1st percentile for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR</p><p align=""justify"">(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17246_17248_R","Initial treatment","AUTHORITY_REQUIRED","17248","17246","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Initial treatment</p><br/><p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Initial treatment</p><br/><p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17247_17263_R","Initial treatment","AUTHORITY_REQUIRED","17263","17247","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Initial treatment</p><br/><p>Patient must have a structural lesion that is not neoplastic; or</p> <p>Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); or</p> <p>Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND</p> <p>Patient must have hypothalamic obesity; AND</p> <p>Patient must have a growth velocity above the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have an annual growth velocity of greater than 14 cm per year if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have an annual growth velocity of greater than 8 cm per year if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR</p><p align=""justify"">(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR</p><p align=""justify"">(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p><p align=""justify"">7. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND</p><p align=""justify"">8. Confirmation that the patient has hypothalamic obesity; AND</p><p align=""justify"">9. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Testing for biochemical growth hormone deficiency must have been performed at a time when all other pituitary hormone deficits were being adequately replaced.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Initial treatment</p><br/><p>Patient must have a structural lesion that is not neoplastic; or</p> <p>Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); or</p> <p>Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND</p> <p>Patient must have hypothalamic obesity; AND</p> <p>Patient must have a growth velocity above the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have an annual growth velocity of greater than 14 cm per year if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have an annual growth velocity of greater than 8 cm per year if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR</p><p align=""justify"">(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR</p><p align=""justify"">(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p><p align=""justify"">7. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND</p><p align=""justify"">8. Confirmation that the patient has hypothalamic obesity; AND</p><p align=""justify"">9. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Testing for biochemical growth hormone deficiency must have been performed at a time when all other pituitary hormone deficits were being adequately replaced.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17249_17261_R","Initial treatment","AUTHORITY_REQUIRED","17261","17249","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must not have a bone age of 13.5 years or greater.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR</p><p align=""justify"">(b) A minimum of 6 months of recent growth data (height and weight) for older children (females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must not have a bone age of 13.5 years or greater.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR</p><p align=""justify"">(b) A minimum of 6 months of recent growth data (height and weight) for older children (females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17251_17241_R","Initial treatment","AUTHORITY_REQUIRED","17241","17251","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17254_17250_R","Initial treatment","AUTHORITY_REQUIRED","17250","17254","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Initial treatment</p><br/><p>Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; or</p> <p>Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; or</p> <p>Patient must be female and menarche occurred before the chronological age of 10 years; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR</p><p align=""justify"">(b) A minimum of 6 months of recent growth data (height and weight) for older children (males chronological age 12 and over or bone age 10 and over, females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. Confirmation that the patient has precocious puberty; AND</p><p align=""justify"">7. Confirmation that the patient is undergoing Gonadotropin Releasing Hormone agonist therapy, for pubertal suppression; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Initial treatment</p><br/><p>Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; or</p> <p>Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; or</p> <p>Patient must be female and menarche occurred before the chronological age of 10 years; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR</p><p align=""justify"">(b) A minimum of 6 months of recent growth data (height and weight) for older children (males chronological age 12 and over or bone age 10 and over, females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. Confirmation that the patient has precocious puberty; AND</p><p align=""justify"">7. Confirmation that the patient is undergoing Gonadotropin Releasing Hormone agonist therapy, for pubertal suppression; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17257_17258_R","Initial treatment","AUTHORITY_REQUIRED","17258","17257","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Initial treatment</p><br/><p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Initial treatment</p><br/><p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17260_17311_R","Initial treatment","AUTHORITY_REQUIRED","17311","17260","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and poor body composition due to Prader-Willi syndrome</p><br/><p>Initial treatment</p><br/><p>Patient must have diagnostic results consistent with Prader-Willi syndrome (the condition must be genetically proven); or</p> <p>Patient must have a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with no sleep disorders identified; or</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified which are not of sufficient severity to require treatment; or</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified for which the patient is currently receiving ameliorative treatment; AND</p> <p>Patient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient''s current height; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must not have a chronological age of 18 years or greater; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""left"">The authority application must be in writing and must include:</p><p align=""left"">1. Details of the proposed prescription; AND</p><p align=""left"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""left"">3. A minimum of 6 months of recent growth data (height, weight and waist circumference). The most recent data must not be older than three months; AND</p><p align=""left"">4. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND</p><p align=""left"">5. (a) Confirmation that the patient has diagnostic results consistent with Prader-Willi syndrome; OR</p><p align=""left"">(b) Confirmation that the patient has a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist</p><p align=""left"">6. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months and any sleep disorders identified via polysomnography that required treatment have been addressed; AND</p><p align=""left"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with 1 repeat allowed)</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and poor body composition due to Prader-Willi syndrome</p><br/><p>Initial treatment</p><br/><p>Patient must have diagnostic results consistent with Prader-Willi syndrome (the condition must be genetically proven); or</p> <p>Patient must have a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist; AND</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with no sleep disorders identified; or</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified which are not of sufficient severity to require treatment; or</p> <p>Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified for which the patient is currently receiving ameliorative treatment; AND</p> <p>Patient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient''s current height; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must not have a chronological age of 18 years or greater; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""left"">The authority application must be in writing and must include:</p><p align=""left"">1. Details of the proposed prescription; AND</p><p align=""left"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""left"">3. A minimum of 6 months of recent growth data (height, weight and waist circumference). The most recent data must not be older than three months; AND</p><p align=""left"">4. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND</p><p align=""left"">5. (a) Confirmation that the patient has diagnostic results consistent with Prader-Willi syndrome; OR</p><p align=""left"">(b) Confirmation that the patient has a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist</p><p align=""left"">6. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months and any sleep disorders identified via polysomnography that required treatment have been addressed; AND</p><p align=""left"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with 1 repeat allowed)</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17264_17262_R","Initial treatment","AUTHORITY_REQUIRED","17262","17264","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Initial treatment</p><br/><p>Patient must have had an intracranial lesion which is under appropriate observation and management; or</p> <p>Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st percentile for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st percentile for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1st percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR</p><p align=""justify"">(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Initial treatment</p><br/><p>Patient must have had an intracranial lesion which is under appropriate observation and management; or</p> <p>Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st percentile for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st percentile for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1st percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR</p><p align=""justify"">(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17266_4306_R","null","AUTHORITY_REQUIRED","4306","17266","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of hepatic encephalopathy</p><br/><p>Must be treated by a gastroenterologist or hepatologist or in consultation with a gastroenterologist or hepatologist; AND</p> <p>The treatment must be in combination with lactulose, if lactulose is tolerated; AND</p> <p>Patient must have had prior episodes of hepatic encephalopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of hepatic encephalopathy</p><br/><p>Must be treated by a gastroenterologist or hepatologist or in consultation with a gastroenterologist or hepatologist; AND</p> <p>The treatment must be in combination with lactulose, if lactulose is tolerated; AND</p> <p>Patient must have had prior episodes of hepatic encephalopathy.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17267_17268_R","null","STREAMLINED","17268","17267","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cystic acne</p><br/><p>The condition must be unresponsive to other therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where this prescription is to continue existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe cystic acne</p><br/><p>The condition must be unresponsive to other therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where this prescription is to continue existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17269_17402_R","Continuing treatment","STREAMLINED","17402","17269","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial homozygous hypercholesterolaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where patient care is being shared with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial homozygous hypercholesterolaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where patient care is being shared with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17271_17272_R","null","STREAMLINED","17272","17271","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disorders of keratinisation</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where this prescription is to continue existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disorders of keratinisation</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where this prescription is to continue existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17273_4229_R","null","AUTHORITY_REQUIRED","4229","17273","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Superficial basal cell carcinoma</p><br/><p>The condition must be previously untreated; AND</p> <p>The condition must be confirmed by biopsy; AND</p> <p>Patient must have normal immune function; AND</p> <p>The condition must not be suitable for treatment with surgical excision; or</p> <p>The condition must not be suitable for treatment with cryotherapy; or</p> <p>The condition must not be suitable for treatment with curettage with diathermy; AND</p> <p>Patient must require topical drug therapy.</p> <p align=""justify"">The date of the pathology report and name of the Approved Pathology Authority must be provided at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Superficial basal cell carcinoma</p><br/><p>The condition must be previously untreated; AND</p> <p>The condition must be confirmed by biopsy; AND</p> <p>Patient must have normal immune function; AND</p> <p>The condition must not be suitable for treatment with surgical excision; or</p> <p>The condition must not be suitable for treatment with cryotherapy; or</p> <p>The condition must not be suitable for treatment with curettage with diathermy; AND</p> <p>Patient must require topical drug therapy.</p> <p align=""justify"">The date of the pathology report and name of the Approved Pathology Authority must be provided at the time of application.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17274_17381_R","null","STREAMLINED","17381","17274","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteomyelitis</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where this prescription is to continue existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteomyelitis</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where this prescription is to continue existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17275_17320_R","Initial treatment 1 - new patient","AUTHORITY_REQUIRED","17320","17275","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic pulmonary fibrosis</p><br/><p>Initial treatment 1 - new patient</p><br/><p>The condition must be diagnosed through a multidisciplinary team; AND</p> <p>Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND</p> <p>Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND</p> <p>Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND</p> <p>Patient must not have had an acute respiratory infection at the time of FVC measurement; AND</p> <p>Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND</p> <p>Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient''s guardian the following: (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.</p> <p align=""justify"">A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.</p> <p align=""justify"">Document in the patient&apos;s medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic pulmonary fibrosis</p><br/><p>Initial treatment 1 - new patient</p><br/><p>The condition must be diagnosed through a multidisciplinary team; AND</p> <p>Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND</p> <p>Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND</p> <p>Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND</p> <p>Patient must not have had an acute respiratory infection at the time of FVC measurement; AND</p> <p>Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND</p> <p>Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient''s guardian the following: (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.</p> <p align=""justify"">A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.</p> <p align=""justify"">Document in the patient&apos;s medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-10-01","Y","4708"
"17276_17329_R","Continuing treatment","AUTHORITY_REQUIRED","17329","17276","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic pulmonary fibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic pulmonary fibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17279_7890_R","Continuing treatment","STREAMLINED","7890","17279","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17281_17326_R","First continuing treatment","AUTHORITY_REQUIRED","17326","17281","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-10-01","Y","4708"
"17282_14603_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","14603","17282","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient&apos;s medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the active joint count, ESR and/or CRP result and date of result;</p><p align=""justify"">(b) the most recent biological agent and the date of the last continuing prescription.</p><p align=""justify"">(c) If applicable, the new baseline scores.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient&apos;s medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the active joint count, ESR and/or CRP result and date of result;</p><p align=""justify"">(b) the most recent biological agent and the date of the last continuing prescription.</p><p align=""justify"">(c) If applicable, the new baseline scores.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17283_17284_R","Initial treatment - Initial 2 (Change of treatment)","AUTHORITY_REQUIRED","17284","17283","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine in this treatment cycle for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have had a total serum human immunoglobulin E of at least 30 IU/mL with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to less than 12 years; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must be under the care of the same physician for at least 6 months.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma or severe allergic asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made no more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 24 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment at around 24 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.</p><p align=""justify"">A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date of the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the IgE result and date; and</p><p align=""justify"">(b) Asthma Control Questionnaire (ACQ-5) score; or</p><p align=""justify"">(c) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.</p><p align=""justify"">(d) the details of prior biological medicine treatment including the details of date and duration of treatment; and</p><p align=""justify"">(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe allergic asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine in this treatment cycle for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must have had a total serum human immunoglobulin E of at least 30 IU/mL with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to less than 12 years; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for either: (i) severe asthma, (ii) severe allergic asthma; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND</p> <p>Patient must be under the care of the same physician for at least 6 months.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma or severe allergic asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made no more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 24 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment at around 24 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.</p><p align=""justify"">A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date of the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the IgE result and date; and</p><p align=""justify"">(b) Asthma Control Questionnaire (ACQ-5) score; or</p><p align=""justify"">(c) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.</p><p align=""justify"">(d) the details of prior biological medicine treatment including the details of date and duration of treatment; and</p><p align=""justify"">(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17286_17286_R","null","STREAMLINED","17286","17286","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Patient must have/have had a WHO performance status of no greater than 2 at treatment initiation with this drug for this condition; AND</p> <p>The condition must be positive for a BRAF V600E mutation; AND</p> <p>Patient must be receiving trametinib and dabrafenib concomitantly for this condition; AND</p> <p>Patient must be undergoing initial treatment with this drug; or</p> <p>Patient must be undergoing continuing treatment with this drug, with an absence of further disease progression while being treated with this drug; or</p> <p>Patient must be undergoing non-PBS-subsidised treatment with this drug for this PBS indication, with an absence of further disease progression since commencing non-PBS-subsidised supply.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Patient must have/have had a WHO performance status of no greater than 2 at treatment initiation with this drug for this condition; AND</p> <p>The condition must be positive for a BRAF V600E mutation; AND</p> <p>Patient must be receiving trametinib and dabrafenib concomitantly for this condition; AND</p> <p>Patient must be undergoing initial treatment with this drug; or</p> <p>Patient must be undergoing continuing treatment with this drug, with an absence of further disease progression while being treated with this drug; or</p> <p>Patient must be undergoing non-PBS-subsidised treatment with this drug for this PBS indication, with an absence of further disease progression since commencing non-PBS-subsidised supply.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17287_17399_R","Continuing treatment","AUTHORITY_REQUIRED","17399","17287","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary hyperoxaluria type 1</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must continue to demonstrate clinical benefit as assessed by the treating physician; AND</p> <p>Patient must not have previously undergone liver transplant for primary hyperoxaluria type 1; AND</p> <p>Must be treated by a nephrologist with experience in the management of hyperoxaluria; or</p> <p>Must be treated by a paediatrician with experience in the management of hyperoxaluria; or</p> <p>Must be treated by an authorised prescriber in consultation with one of the above specialty types.</p> <p align=""justify"">At the time of the authority application, prescribers should request the appropriate number of vials based on the patient&apos;s weight, as per the TGA approved Product Information. Up to 1 repeat may be requested for continuing treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary hyperoxaluria type 1</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must continue to demonstrate clinical benefit as assessed by the treating physician; AND</p> <p>Patient must not have previously undergone liver transplant for primary hyperoxaluria type 1; AND</p> <p>Must be treated by a nephrologist with experience in the management of hyperoxaluria; or</p> <p>Must be treated by a paediatrician with experience in the management of hyperoxaluria; or</p> <p>Must be treated by an authorised prescriber in consultation with one of the above specialty types.</p> <p align=""justify"">At the time of the authority application, prescribers should request the appropriate number of vials based on the patient&apos;s weight, as per the TGA approved Product Information. Up to 1 repeat may be requested for continuing treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17290_17182_R","Recommencement of treatment","AUTHORITY_REQUIRED","17182","17290","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND</p> <p>Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">If a patient receiving treatment under the indication &apos;short stature associated with chronic renal insufficiency&apos; undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m<sup>2</sup> prescribers should seek reclassification to the indication short stature and slow growth.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND</p> <p>Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">If a patient receiving treatment under the indication &apos;short stature associated with chronic renal insufficiency&apos; undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m<sup>2</sup> prescribers should seek reclassification to the indication short stature and slow growth.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17291_17148_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17148","17291","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); or</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR</p><p align=""justify"">(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); or</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR</p><p align=""justify"">(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17297_17179_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17179","17297","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; or</p> <p>Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; or</p> <p>Patient must be female and menarche occurred before the chronological age of 10 years; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. Confirmation that the patient has precocious puberty; AND</p><p align=""justify"">4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; or</p> <p>Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; or</p> <p>Patient must be female and menarche occurred before the chronological age of 10 years; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. Confirmation that the patient has precocious puberty; AND</p><p align=""justify"">4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17299_17388_R","Recommencement of treatment","AUTHORITY_REQUIRED","17388","17299","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a chronological age of 5 years or greater; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a chronological age of 5 years or greater; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND</p><p align=""justify"">3. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17302_17180_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17180","17302","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature assciated with Turner syndrome; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must not have a bone age of 13.5 years or greater; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. A height measurement from immediately prior to commencement of growth hormone treatment; AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND</p><p align=""justify"">5. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature assciated with Turner syndrome; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must not have a bone age of 13.5 years or greater; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. A height measurement from immediately prior to commencement of growth hormone treatment; AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND</p><p align=""justify"">5. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17303_17308_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17308","17303","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a bone age of 13.5 years or greater; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. A height measurement from immediately prior to commencement of growth hormone treatment; AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND</p><p align=""justify"">5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a bone age of 13.5 years or greater; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. A height measurement from immediately prior to commencement of growth hormone treatment; AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND</p><p align=""justify"">5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17312_17380_R","Initial treatment","AUTHORITY_REQUIRED","17380","17312","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must not have a bone age of 13.5 years or greater; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR</p><p align=""justify"">(b) A minimum of 6 months of recent growth data (height and weight) for older children (females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; or</p> <p>Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must not have a bone age of 13.5 years or greater; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR</p><p align=""justify"">(b) A minimum of 6 months of recent growth data (height and weight) for older children (females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17314_17270_R","null","STREAMLINED","17270","17314","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe scalp psoriasis</p><br/><p>The condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy; or</p> <p>The condition must be inadequately controlled with combination use of a vitamin D analogue and potent topical corticosteroid; AND</p> <p>Patient must be at least 18 years of age.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe scalp psoriasis</p><br/><p>The condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy; or</p> <p>The condition must be inadequately controlled with combination use of a vitamin D analogue and potent topical corticosteroid; AND</p> <p>Patient must be at least 18 years of age.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17315_17316_R","null","STREAMLINED","17316","17315","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe intractable psoriasis</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where this prescription is to continue existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe intractable psoriasis</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where this prescription is to continue existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17317_6200_R","null","RESTRICTED","6200","17317","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17318_15625_R","null","RESTRICTED","15625","17318","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17319_17391_R","null","STREAMLINED","17391","17319","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Patient must not have achieved adequate response after at least 6 weeks of treatment with methotrexate prior to initiating treatment with this drug; or</p> <p>Patient must have a contraindication to methotrexate according to the Therapeutic Goods Administration (TGA) approved Product Information; or</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; AND</p> <p>The condition must have caused significant interference with quality of life; AND</p> <p>Patient must not be undergoing concurrent PBS-subsidised treatment for psoriasis with each of: (i) a biological medicine, (ii) ciclosporin, (iii) apremilast; AND</p> <p>Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; or</p> <p>Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar; or</p> <p>Must be treated by a prescriber who is not any of the above, but where there is agreement to continue treatment (not initiate treatment) with one of the above practitioner types; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">For patients who do not demonstrate an adequate response to deucravacitinib, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to &apos;biological medicines&apos; for the treatment of &apos;severe chronic plaque psoriasis&apos;.</p><p align=""justify"">This assessment must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Patient must not have achieved adequate response after at least 6 weeks of treatment with methotrexate prior to initiating treatment with this drug; or</p> <p>Patient must have a contraindication to methotrexate according to the Therapeutic Goods Administration (TGA) approved Product Information; or</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; AND</p> <p>The condition must have caused significant interference with quality of life; AND</p> <p>Patient must not be undergoing concurrent PBS-subsidised treatment for psoriasis with each of: (i) a biological medicine, (ii) ciclosporin, (iii) apremilast; AND</p> <p>Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; or</p> <p>Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar; or</p> <p>Must be treated by a prescriber who is not any of the above, but where there is agreement to continue treatment (not initiate treatment) with one of the above practitioner types; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">For patients who do not demonstrate an adequate response to deucravacitinib, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to &apos;biological medicines&apos; for the treatment of &apos;severe chronic plaque psoriasis&apos;.</p><p align=""justify"">This assessment must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17321_17372_R","Initial treatment","AUTHORITY_REQUIRED","17372","17321","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive fibrosing Interstitial lung disease</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed through a multidisciplinary team; AND</p> <p>The condition must have chest imaging through high resolution computed tomography (HRCT) that is no older than 12 months, to support the diagnosis of the PBS indication; AND</p> <p>The condition must display, through HRCT, an affected area of no less than 10% (after rounding to the nearest multiple of 5); AND</p> <p>Patient must have a current (no older than 2 years) forced vital capacity (FVC) measurement of no less than 45% predicted, adjusted for each of: (i) age, (ii) gender, (iii) height; AND</p> <p>The condition must be of a progressive nature, observed by, in the 2 years leading up to this authority application, any of: (i) a worsening in relative FVC% predicted measurement of no less than 10%, (ii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with worsening of respiratory symptoms, (iii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with increases in fibrosis observed on HRCT; document at least one of (i) to (iii) in the patient''s medical records; AND</p> <p>Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND</p> <p>Patient must not have had an acute respiratory infection at the time of FVC measurement; AND</p> <p>Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin that is both: (i) at least 30% predicted, (ii) no greater than 80% predicted; AND</p> <p>The condition must not be interstitial lung disease due to idiopathic pulmonary fibrosis (apply under the correct PBS listing if it is); AND</p> <p>The condition must not be due to reversible causes (e.g. drug toxicity); AND</p> <p>Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient''s guardian the following: (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.</p> <p align=""justify"">Document in the patient&apos;s medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive fibrosing Interstitial lung disease</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed through a multidisciplinary team; AND</p> <p>The condition must have chest imaging through high resolution computed tomography (HRCT) that is no older than 12 months, to support the diagnosis of the PBS indication; AND</p> <p>The condition must display, through HRCT, an affected area of no less than 10% (after rounding to the nearest multiple of 5); AND</p> <p>Patient must have a current (no older than 2 years) forced vital capacity (FVC) measurement of no less than 45% predicted, adjusted for each of: (i) age, (ii) gender, (iii) height; AND</p> <p>The condition must be of a progressive nature, observed by, in the 2 years leading up to this authority application, any of: (i) a worsening in relative FVC% predicted measurement of no less than 10%, (ii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with worsening of respiratory symptoms, (iii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with increases in fibrosis observed on HRCT; document at least one of (i) to (iii) in the patient''s medical records; AND</p> <p>Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND</p> <p>Patient must not have had an acute respiratory infection at the time of FVC measurement; AND</p> <p>Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin that is both: (i) at least 30% predicted, (ii) no greater than 80% predicted; AND</p> <p>The condition must not be interstitial lung disease due to idiopathic pulmonary fibrosis (apply under the correct PBS listing if it is); AND</p> <p>The condition must not be due to reversible causes (e.g. drug toxicity); AND</p> <p>Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient''s guardian the following: (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.</p> <p align=""justify"">Document in the patient&apos;s medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient&apos;s medical records.</p> <p align=""justify"">Interstitial lung disease includes, but is not limited to:</p><p align=""justify"">(i) connective tissue associated interstitial lung disease;</p><p align=""justify"">(ii) chronic fibrosing hypersensitivity pneumonitis;</p><p align=""justify"">(iii) idiopathic non-specific interstitial pneumonia;</p><p align=""justify"">(iv) pulmonary sarcoidosis.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-10-01","Y","4708"
"17322_17323_R","null","RESTRICTED","17323","17322","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17324_7876_R","Initial treatment","STREAMLINED","7876","17324","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Initial treatment</p><br/><p>Must be treated by a paediatrician or psychiatrist; AND</p> <p>The condition must be or have been diagnosed according to the DSM-5 criteria; AND</p> <p>Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; or</p> <p>Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; or</p> <p>Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; or</p> <p>Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously); AND</p> <p>Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Initial treatment</p><br/><p>Must be treated by a paediatrician or psychiatrist; AND</p> <p>The condition must be or have been diagnosed according to the DSM-5 criteria; AND</p> <p>Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; or</p> <p>Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; or</p> <p>Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; or</p> <p>Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously); AND</p> <p>Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17327_17374_R","First continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","17374","17327","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-10-01","Y","4708"
"17331_17168_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17168","17331","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had an intracranial lesion which is under appropriate observation and management; or</p> <p>Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR</p><p align=""justify"">(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had an intracranial lesion which is under appropriate observation and management; or</p> <p>Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR</p><p align=""justify"">(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17334_17212_R","Continuing treatment","AUTHORITY_REQUIRED","17212","17334","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a chronological age of 5 years or greater; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">When a patient receiving treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants reaches or surpasses 5 years of age (chronological), prescribers should seek reclassification to the indication &apos;short stature due to biochemical growth hormone deficiency&apos;.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a chronological age of 5 years or greater; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">When a patient receiving treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants reaches or surpasses 5 years of age (chronological), prescribers should seek reclassification to the indication &apos;short stature due to biochemical growth hormone deficiency&apos;.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17335_17366_R","Continuing treatment","AUTHORITY_REQUIRED","17366","17335","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17336_17304_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17304","17336","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have a structural lesion that is not neoplastic; or</p> <p>Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); or</p> <p>Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND</p> <p>Patient must have hypothalamic obesity; AND</p> <p>Patient must have had a growth velocity above the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR</p><p align=""justify"">(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR</p><p align=""justify"">(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p><p align=""justify"">6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND</p><p align=""justify"">7. Confirmation that the patient has hypothalamic obesity; AND</p><p align=""justify"">8. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">9. A bone age result performed within the last 12 months; AND</p><p align=""justify"">10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have a structural lesion that is not neoplastic; or</p> <p>Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); or</p> <p>Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND</p> <p>Patient must have hypothalamic obesity; AND</p> <p>Patient must have had a growth velocity above the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR</p><p align=""justify"">(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR</p><p align=""justify"">(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p><p align=""justify"">6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND</p><p align=""justify"">7. Confirmation that the patient has hypothalamic obesity; AND</p><p align=""justify"">8. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">9. A bone age result performed within the last 12 months; AND</p><p align=""justify"">10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17337_17309_R","Continuing treatment","AUTHORITY_REQUIRED","17309","17337","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND</p> <p>Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND</p> <p>Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND</p> <p>Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND</p> <p>Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If a patient receiving treatment under the indication short stature due to chronic renal insufficiency undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m<sup>2</sup> prescribers should seek reclassification to the indication short stature and slow growth.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17338_17214_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17214","17338","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had an intracranial lesion which is under appropriate observation and management; or</p> <p>Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR</p><p align=""justify"">(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had an intracranial lesion which is under appropriate observation and management; or</p> <p>Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR</p><p align=""justify"">(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND</p><p align=""justify"">6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17339_17365_R","Continuing treatment","AUTHORITY_REQUIRED","17365","17339","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Growth retardation secondary to an intracranial lesion, or cranial irradiation</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND</p> <p>Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. The final adult height (in cm) of the patient&apos;s mother and father (where available); AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17341_17265_R","Initial treatment","AUTHORITY_REQUIRED","17265","17341","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Initial treatment</p><br/><p>Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; or</p> <p>Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; or</p> <p>Patient must be female and menarche occurred before the chronological age of 10 years; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR</p><p align=""justify"">(b) A minimum of 6 months of recent growth data (height and weight) for older children (males chronological age 12 and over or bone age 10 and over, females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. Confirmation that the patient has precocious puberty; AND</p><p align=""justify"">7. Confirmation that the patient is undergoing Gonadotropin Releasing Hormone agonist therapy, for pubertal suppression; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biochemical growth hormone deficiency and precocious puberty</p><br/><p>Initial treatment</p><br/><p>Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; or</p> <p>Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; or</p> <p>Patient must be female and menarche occurred before the chronological age of 10 years; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR</p><p align=""justify"">(b) A minimum of 6 months of recent growth data (height and weight) for older children (males chronological age 12 and over or bone age 10 and over, females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. Confirmation that the patient has precocious puberty; AND</p><p align=""justify"">7. Confirmation that the patient is undergoing Gonadotropin Releasing Hormone agonist therapy, for pubertal suppression; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17342_17369_R","Initial treatment","AUTHORITY_REQUIRED","17369","17342","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR</p><p align=""justify"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17343_17310_R","Initial treatment","AUTHORITY_REQUIRED","17310","17343","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must have a structural lesion that is not neoplastic; or</p> <p>Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); or</p> <p>Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND</p> <p>Patient must have hypothalamic obesity; AND</p> <p>Patient must have a growth velocity above the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have an annual growth velocity of greater than 8 cm per year if the patient has a bone age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR</p><p align=""justify"">(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR</p><p align=""justify"">(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p><p align=""justify"">7. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND</p><p align=""justify"">8. Confirmation that the patient has hypothalamic obesity; AND</p><p align=""justify"">9. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Testing for biochemical growth hormone deficiency must have been performed at a time when all other pituitary hormone deficits were being adequately replaced.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must have a structural lesion that is not neoplastic; or</p> <p>Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); or</p> <p>Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND</p> <p>Patient must have hypothalamic obesity; AND</p> <p>Patient must have a growth velocity above the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have an annual growth velocity of greater than 8 cm per year if the patient has a bone age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">6. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR</p><p align=""justify"">(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR</p><p align=""justify"">(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p><p align=""justify"">7. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND</p><p align=""justify"">8. Confirmation that the patient has hypothalamic obesity; AND</p><p align=""justify"">9. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Testing for biochemical growth hormone deficiency must have been performed at a time when all other pituitary hormone deficits were being adequately replaced.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17344_14868_R","null","STREAMLINED","14868","17344","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe androgenisation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must not be indicated by acne alone, as this is not a sufficient indication of androgenisation; AND</p> <p>Patient must be female; AND</p> <p>Patient must not be pregnant.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe androgenisation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must not be indicated by acne alone, as this is not a sufficient indication of androgenisation; AND</p> <p>Patient must be female; AND</p> <p>Patient must not be pregnant.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17345_5482_R","null","STREAMLINED","5482","17345","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atopic dermatitis</p><br/><p>Patient must be at least 3 months of age; AND</p> <p>The condition must be on the patient''s face; or</p> <p>The condition must be on the patient''s eyelid; AND</p> <p>Patient must have 1 or more of the following contraindications to topical corticosteroids: (i) perioral dermatitis; (ii) periorbital dermatitis; (iii) rosacea; (iv) epidermal atrophy; (v) dermal atrophy; (vi) allergy to topical corticosteroids; (vii) cataracts; (viii) glaucoma; (ix) raised intraocular pressure; AND</p> <p>Patient must not receive more than two 15 g packs of PBS-subsidised pimecrolimus per 6-month period.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atopic dermatitis</p><br/><p>Patient must be at least 3 months of age; AND</p> <p>The condition must be on the patient''s face; or</p> <p>The condition must be on the patient''s eyelid; AND</p> <p>Patient must have 1 or more of the following contraindications to topical corticosteroids: (i) perioral dermatitis; (ii) periorbital dermatitis; (iii) rosacea; (iv) epidermal atrophy; (v) dermal atrophy; (vi) allergy to topical corticosteroids; (vii) cataracts; (viii) glaucoma; (ix) raised intraocular pressure; AND</p> <p>Patient must not receive more than two 15 g packs of PBS-subsidised pimecrolimus per 6-month period.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17346_6201_R","null","STREAMLINED","6201","17346","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prophylaxis of Pneumocystis jiroveci pneumonia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prophylaxis of Pneumocystis jiroveci pneumonia</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17347_17403_R","null","STREAMLINED","17403","17347","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven Pseudomonas aeruginosa infection</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have cystic fibrosis; AND</p> <p>The treatment must be for management; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where patient care is being shared with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven Pseudomonas aeruginosa infection</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have cystic fibrosis; AND</p> <p>The treatment must be for management; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where patient care is being shared with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17348_17349_R","null","STREAMLINED","17349","17348","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven Pseudomonas aeruginosa infection</p><br/><p>Patient must have cystic fibrosis; AND</p> <p>The treatment must be for management; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where patient care is being shared with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven Pseudomonas aeruginosa infection</p><br/><p>Patient must have cystic fibrosis; AND</p> <p>The treatment must be for management; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where patient care is being shared with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17350_5636_R","null","AUTHORITY_REQUIRED","5636","17350","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Antibiotic associated pseudomembranous colitis</p><br/><p>The condition must be due to Clostridium difficile; AND</p> <p>Patient must have an intolerance to metronidazole.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Antibiotic associated pseudomembranous colitis</p><br/><p>The condition must be due to Clostridium difficile; AND</p> <p>Patient must have an intolerance to metronidazole.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17352_13771_R","null","RESTRICTED","13771","17352","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active psoriatic arthritis</p><br/><p>Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or</p> <p>Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND</p> <p>The treatment must be initiated by a physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active psoriatic arthritis</p><br/><p>Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or</p> <p>Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND</p> <p>The treatment must be initiated by a physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17353_14941_R","null","RESTRICTED","14941","17353","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active psoriatic arthritis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or</p> <p>Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND</p> <p>The treatment must be initiated by a physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active psoriatic arthritis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or</p> <p>Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND</p> <p>The treatment must be initiated by a physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17354_17278_R","null","RESTRICTED","17278","17354","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17362_17149_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17149","17362","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with chronic renal insufficiency</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; or</p> <p>Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p><p align=""justify"">4. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m<sup>2</sup> ; AND</p><p align=""justify"">5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If a patient receiving treatment under the indication short stature due to chronic renal insufficiency undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m<sup>2</sup> prescribers should seek reclassification to the indication short stature and slow growth.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17363_17294_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17294","17363","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND</p><p align=""justify"">5. If the patient&apos;s condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient&apos;s increased risk of gonadoblastoma is in place; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND</p><p align=""justify"">5. If the patient&apos;s condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient&apos;s increased risk of gonadoblastoma is in place; AND</p><p align=""justify"">6. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">7. A bone age result performed within the last 12 months; AND</p><p align=""justify"">8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17364_17333_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","17333","17364","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have a structural lesion that is not neoplastic; or</p> <p>Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); or</p> <p>Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND</p> <p>Patient must have hypothalamic obesity; AND</p> <p>Patient must have had a growth velocity above the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR</p><p align=""justify"">(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR</p><p align=""justify"">(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p><p align=""justify"">6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND</p><p align=""justify"">7. Confirmation that the patient has hypothalamic obesity; AND</p><p align=""justify"">8. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">9. A bone age result performed within the last 12 months; AND</p><p align=""justify"">10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND</p> <p>Patient must have had a lapse in treatment; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have a structural lesion that is not neoplastic; or</p> <p>Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); or</p> <p>Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND</p> <p>Patient must have hypothalamic obesity; AND</p> <p>Patient must have had a growth velocity above the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND</p><p align=""justify"">3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR</p><p align=""justify"">(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR</p><p align=""justify"">(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND</p><p align=""justify"">6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND</p><p align=""justify"">7. Confirmation that the patient has hypothalamic obesity; AND</p><p align=""justify"">8. Recent growth data (height and weight, not older than three months); AND</p><p align=""justify"">9. A bone age result performed within the last 12 months; AND</p><p align=""justify"">10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17367_17340_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","17340","17367","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); or</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age and sex immediately prior to commencing treatment; OR</p><p align=""justify"">(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">6. A bone age result performed within the last 12 months; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or</p> <p>The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND</p> <p>Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); or</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND</p><p align=""justify"">3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age and sex immediately prior to commencing treatment; OR</p><p align=""justify"">(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND</p><p align=""justify"">4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND</p><p align=""justify"">5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">6. A bone age result performed within the last 12 months; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17368_17230_R","Continuing treatment","AUTHORITY_REQUIRED","17230","17368","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND</p> <p>Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an annualised growth velocity for bone age at or above the mean growth velocity for untreated Turner Syndrome girls (using the Turner Syndrome - Ranke growth velocity chart) while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a bone age of 13.5 years or greater; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with Turner syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND</p> <p>Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or</p> <p>Patient must have achieved an annualised growth velocity for bone age at or above the mean growth velocity for untreated Turner Syndrome girls (using the Turner Syndrome - Ranke growth velocity chart) while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have a bone age of 13.5 years or greater; AND</p> <p>Patient must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND</p><p align=""justify"">5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17370_5532_R","null","STREAMLINED","5532","17370","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe androgenisation</p><br/><p>The condition must not be indicated by acne alone, as this is not a sufficient indication of androgenisation; AND</p> <p>Patient must be female; AND</p> <p>Patient must not be pregnant.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe androgenisation</p><br/><p>The condition must not be indicated by acne alone, as this is not a sufficient indication of androgenisation; AND</p> <p>Patient must be female; AND</p> <p>Patient must not be pregnant.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17371_17313_R","Initial treatment","STREAMLINED","17313","17371","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial homozygous hypercholesterolaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>The condition must have been confirmed by genetic testing; or</p> <p>The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 7; AND</p> <p>Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND</p> <p>Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; or</p> <p>Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by an authorised prescriber in consultation with a specialist physician.</p> <p align=""justify"">The qualifying LDL cholesterol level following at least 12 consecutive weeks of treatment with a statin (unless treatment with a statin is contraindicated or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient&apos;s medical records and must be no more than 8 weeks old.</p> <p align=""justify"">A clinically important product-related adverse event is defined as follows: </p><p align=""justify"">(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or </p><p align=""justify"">(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or </p><p align=""justify"">(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(i) the qualifying Dutch Lipid Clinic Network Score; or</p><p align=""justify"">(ii) the result of genetic testing confirming a diagnosis of familial homozygous hypercholesterolaemia</p> <p align=""justify"">One of the following must be documented in the patient&apos;s medical records regarding prior statin treatment:</p><p align=""justify"">(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or</p><p align=""justify"">(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or</p><p align=""justify"">(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.</p> <p align=""justify"">Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial homozygous hypercholesterolaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be in conjunction with dietary therapy and exercise; AND</p> <p>The condition must have been confirmed by genetic testing; or</p> <p>The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 7; AND</p> <p>Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND</p> <p>Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; or</p> <p>Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; or</p> <p>Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND</p> <p>Must be treated by a specialist physician; or</p> <p>Must be treated by an authorised prescriber in consultation with a specialist physician.</p> <p align=""justify"">The qualifying LDL cholesterol level following at least 12 consecutive weeks of treatment with a statin (unless treatment with a statin is contraindicated or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient&apos;s medical records and must be no more than 8 weeks old.</p> <p align=""justify"">A clinically important product-related adverse event is defined as follows: </p><p align=""justify"">(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or </p><p align=""justify"">(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or </p><p align=""justify"">(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(i) the qualifying Dutch Lipid Clinic Network Score; or</p><p align=""justify"">(ii) the result of genetic testing confirming a diagnosis of familial homozygous hypercholesterolaemia</p> <p align=""justify"">One of the following must be documented in the patient&apos;s medical records regarding prior statin treatment:</p><p align=""justify"">(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or</p><p align=""justify"">(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or</p><p align=""justify"">(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.</p> <p align=""justify"">Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17373_14582_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","14582","17373","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17375_17397_R","Initial treatment","STREAMLINED","17397","17375","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven Pseudomonas aeruginosa infection</p><br/><p>Initial treatment</p><br/><p>Patient must have cystic fibrosis; AND</p> <p>Patient must have been assessed for bronchial hyperresponsiveness as per the TGA-approved Product Information, with a negative test result; AND</p> <p>Patient must be participating in a four week trial of tobramycin inhalation powder and will be assessed for ability to tolerate the dry powder formulation in order to qualify for continued PBS-subsidised therapy. The trial commencement date must be documented in the patient''s medical records; AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where patient care is being shared with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven Pseudomonas aeruginosa infection</p><br/><p>Initial treatment</p><br/><p>Patient must have cystic fibrosis; AND</p> <p>Patient must have been assessed for bronchial hyperresponsiveness as per the TGA-approved Product Information, with a negative test result; AND</p> <p>Patient must be participating in a four week trial of tobramycin inhalation powder and will be assessed for ability to tolerate the dry powder formulation in order to qualify for continued PBS-subsidised therapy. The trial commencement date must be documented in the patient''s medical records; AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where patient care is being shared with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17376_17356_R","Continuing treatment","AUTHORITY_REQUIRED","17356","17376","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic pulmonary fibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic pulmonary fibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17379_17253_R","Initial treatment","AUTHORITY_REQUIRED","17253","17379","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Initial treatment</p><br/><p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; AND</p> <p>Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND</p><p align=""justify"">6. If the patient&apos;s condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient&apos;s increased risk of gonadoblastoma is in place; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature due to short stature homeobox (SHOX) gene disorders</p><br/><p>Initial treatment</p><br/><p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or</p> <p>Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient''s increased risk of gonadoblastoma; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; AND</p> <p>Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be aged 3 years or older; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the <i>National Health (Growth Hormone Program) Special Arrangement 2025</i> and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription; AND</p><p align=""justify"">2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND</p><p align=""justify"">3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND</p><p align=""justify"">4. A bone age result performed within the last 12 months; AND</p><p align=""justify"">5. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND</p><p align=""justify"">6. If the patient&apos;s condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient&apos;s increased risk of gonadoblastoma is in place; AND</p><p align=""justify"">7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks&apos; worth of treatment (with up to 1 repeat allowed).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17382_14942_R","null","RESTRICTED","14942","17382","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or</p> <p>Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND</p> <p>The treatment must be initiated by a physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or</p> <p>Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND</p> <p>The treatment must be initiated by a physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17383_17393_R","Continuing treatment","AUTHORITY_REQUIRED","17393","17383","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive fibrosing Interstitial lung disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive fibrosing Interstitial lung disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17384_14581_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","14581","17384","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient&apos;s medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient&apos;s medical records.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient&apos;s medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the active joint count, ESR and/or CRP result and date of results;</p><p align=""justify"">(b) details of prior treatment, including dose and date/duration of treatment.</p><p align=""justify"">(c) If applicable, details of any contraindications/intolerances.</p><p align=""justify"">(d) If applicable, the maximum tolerated dose of methotrexate.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient&apos;s medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient&apos;s medical records.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient&apos;s medical records.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient&apos;s medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the active joint count, ESR and/or CRP result and date of results;</p><p align=""justify"">(b) details of prior treatment, including dose and date/duration of treatment.</p><p align=""justify"">(c) If applicable, details of any contraindications/intolerances.</p><p align=""justify"">(d) If applicable, the maximum tolerated dose of methotrexate.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17385_17355_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","17355","17385","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2025-10-01","Y","4708"
"17386_17328_R","Continuing treatment","STREAMLINED","17328","17386","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven Pseudomonas aeruginosa infection</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have cystic fibrosis; AND</p> <p>Patient must have previously been issued with an authority prescription for tobramycin inhalation capsules; AND</p> <p>Patient must have demonstrated ability to tolerate the dry powder formulation following the initial 4-week treatment period, as agreed by the patient, the patient''s family (in the case of paediatric patients) and the treating physician(s); AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where patient care is being shared with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven Pseudomonas aeruginosa infection</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have cystic fibrosis; AND</p> <p>Patient must have previously been issued with an authority prescription for tobramycin inhalation capsules; AND</p> <p>Patient must have demonstrated ability to tolerate the dry powder formulation following the initial 4-week treatment period, as agreed by the patient, the patient''s family (in the case of paediatric patients) and the treating physician(s); AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where patient care is being shared with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17389_5472_R","Short-term (up to 3 weeks) intermittent treatment","STREAMLINED","5472","17389","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atopic dermatitis</p><br/><p>Short-term (up to 3 weeks) intermittent treatment</p><br/><p>Patient must be at least 3 months of age; AND</p> <p>The condition must be on the patient''s face; or</p> <p>The condition must be on the patient''s eyelid; AND</p> <p>Patient must have failed to achieve satisfactory disease control with intermittent topical corticosteroid therapy; AND</p> <p>The condition must have been initially diagnosed more than three months prior to this treatment; AND</p> <p>Patient must not receive more than two 15 g packs of PBS-subsidised pimecrolimus per 6-month period.</p> <p align=""justify"">Failure to achieve satisfactory disease control with intermittent topical corticosteroid therapy is manifest by:</p><p align=""justify"">(i) failure of the facial skin to clear despite at least 2 weeks of topical hydrocortisone 1% applied every day; or</p><p align=""justify"">(ii) failure of the facial skin to clear despite at least 1 week of a moderate or potent topical corticosteroid applied every day; or</p><p align=""justify"">(iii) clearing of the facial skin with at least 2 weeks of topical hydrocortisone 1% applied every day, but almost immediate and significant flare in facial disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions; or</p><p align=""justify"">(iv) clearing of the facial skin with at least 1 week of a moderate or potent topical corticosteroid applied every day, but almost immediate and significant flare in facial disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atopic dermatitis</p><br/><p>Short-term (up to 3 weeks) intermittent treatment</p><br/><p>Patient must be at least 3 months of age; AND</p> <p>The condition must be on the patient''s face; or</p> <p>The condition must be on the patient''s eyelid; AND</p> <p>Patient must have failed to achieve satisfactory disease control with intermittent topical corticosteroid therapy; AND</p> <p>The condition must have been initially diagnosed more than three months prior to this treatment; AND</p> <p>Patient must not receive more than two 15 g packs of PBS-subsidised pimecrolimus per 6-month period.</p> <p align=""justify"">Failure to achieve satisfactory disease control with intermittent topical corticosteroid therapy is manifest by:</p><p align=""justify"">(i) failure of the facial skin to clear despite at least 2 weeks of topical hydrocortisone 1% applied every day; or</p><p align=""justify"">(ii) failure of the facial skin to clear despite at least 1 week of a moderate or potent topical corticosteroid applied every day; or</p><p align=""justify"">(iii) clearing of the facial skin with at least 2 weeks of topical hydrocortisone 1% applied every day, but almost immediate and significant flare in facial disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions; or</p><p align=""justify"">(iv) clearing of the facial skin with at least 1 week of a moderate or potent topical corticosteroid applied every day, but almost immediate and significant flare in facial disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17390_5660_R","null","AUTHORITY_REQUIRED","5660","17390","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Antibiotic associated pseudomembranous colitis</p><br/><p>The condition must be due to Clostridium difficile; AND</p> <p>The condition must be unresponsive to metronidazole.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Antibiotic associated pseudomembranous colitis</p><br/><p>The condition must be due to Clostridium difficile; AND</p> <p>The condition must be unresponsive to metronidazole.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17392_13753_R","null","RESTRICTED","13753","17392","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or</p> <p>Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND</p> <p>The treatment must be initiated by a physician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or</p> <p>Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND</p> <p>The treatment must be initiated by a physician.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17394_17277_R","Initial treatment 2 - change or recommencement of treatment","AUTHORITY_REQUIRED","17277","17394","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic pulmonary fibrosis</p><br/><p>Initial treatment 2 - change or recommencement of treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic pulmonary fibrosis</p><br/><p>Initial treatment 2 - change or recommencement of treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types; AND</p> <p>Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND</p> <p>Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17396_17351_R","null","STREAMLINED","17351","17396","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Patient must not have achieved adequate response after at least 6 weeks of treatment with methotrexate prior to initiating treatment with this drug; or</p> <p>Patient must have a contraindication to methotrexate according to the Therapeutic Goods Administration (TGA) approved Product Information; or</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; AND</p> <p>The condition must have caused significant interference with quality of life; AND</p> <p>Patient must not be undergoing concurrent PBS-subsidised treatment for psoriasis with each of: (i) a biological medicine, (ii) ciclosporin, (iii) deucravacitinib; AND</p> <p>Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; or</p> <p>Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar; or</p> <p>Must be treated by a prescriber who is not any of the above, but where there is agreement to continue treatment (not initiate treatment) with one of the above practitioner types; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">For patients who do not demonstrate an adequate response to apremilast, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to &apos;biological medicines&apos; for the treatment of &apos;severe chronic plaque psoriasis&apos;.</p><p align=""justify"">This assessment must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Patient must not have achieved adequate response after at least 6 weeks of treatment with methotrexate prior to initiating treatment with this drug; or</p> <p>Patient must have a contraindication to methotrexate according to the Therapeutic Goods Administration (TGA) approved Product Information; or</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; AND</p> <p>The condition must have caused significant interference with quality of life; AND</p> <p>Patient must not be undergoing concurrent PBS-subsidised treatment for psoriasis with each of: (i) a biological medicine, (ii) ciclosporin, (iii) deucravacitinib; AND</p> <p>Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; or</p> <p>Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar; or</p> <p>Must be treated by a prescriber who is not any of the above, but where there is agreement to continue treatment (not initiate treatment) with one of the above practitioner types; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">For patients who do not demonstrate an adequate response to apremilast, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to &apos;biological medicines&apos; for the treatment of &apos;severe chronic plaque psoriasis&apos;.</p><p align=""justify"">This assessment must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17400_17401_R","Initial treatment - loading dose","AUTHORITY_REQUIRED","17401","17400","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary hyperoxaluria type 1</p><br/><p>Initial treatment - loading dose</p><br/><p>The condition must be primary hyperoxaluria type 1 confirmed by genetic testing; AND</p> <p>Patient must have undergone treatment with pyridoxine therapy; or</p> <p>Patient must have a PH1 allele that is considered not responsive to pyridoxine therapy; or</p> <p>Patient must be contraindicated for pyridoxine therapy as determined by the treating or consulting clinician; AND</p> <p>Patient must have urinary oxalate greater than or equal to 0.70 mmol/24 h/1.73 m2 measured by mean 24-h urinary oxalate excretion from a valid 24-h urine collection; or</p> <p>Patient must have urinary oxalate:creatinine ratio greater than the upper limit of normal based on age on at least two of three single-void collections during screening; or</p> <p>Patient must have clinical symptoms indicative of hyperoxaluria, such as (i) nephrocalcinosis; (ii) renal stones; (iii) renal impairment; (iv) systemic oxalosis; AND</p> <p>Patient must not have previously undergone liver transplant for primary hyperoxaluria type 1; AND</p> <p>Must be treated by a nephrologist with experience in the management of hyperoxaluria; or</p> <p>Must be treated by a paediatrician with experience in the management of hyperoxaluria; or</p> <p>Must be treated by an authorised prescriber in consultation with one of the above specialty types.</p> <p align=""justify"">At the time of the authority application, prescribers should request the appropriate number of vials based on the patient&apos;s weight, as per the TGA approved Product Information. Up to 2 repeats may be requested for initial treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary hyperoxaluria type 1</p><br/><p>Initial treatment - loading dose</p><br/><p>The condition must be primary hyperoxaluria type 1 confirmed by genetic testing; AND</p> <p>Patient must have undergone treatment with pyridoxine therapy; or</p> <p>Patient must have a PH1 allele that is considered not responsive to pyridoxine therapy; or</p> <p>Patient must be contraindicated for pyridoxine therapy as determined by the treating or consulting clinician; AND</p> <p>Patient must have urinary oxalate greater than or equal to 0.70 mmol/24 h/1.73 m2 measured by mean 24-h urinary oxalate excretion from a valid 24-h urine collection; or</p> <p>Patient must have urinary oxalate:creatinine ratio greater than the upper limit of normal based on age on at least two of three single-void collections during screening; or</p> <p>Patient must have clinical symptoms indicative of hyperoxaluria, such as (i) nephrocalcinosis; (ii) renal stones; (iii) renal impairment; (iv) systemic oxalosis; AND</p> <p>Patient must not have previously undergone liver transplant for primary hyperoxaluria type 1; AND</p> <p>Must be treated by a nephrologist with experience in the management of hyperoxaluria; or</p> <p>Must be treated by a paediatrician with experience in the management of hyperoxaluria; or</p> <p>Must be treated by an authorised prescriber in consultation with one of the above specialty types.</p> <p align=""justify"">At the time of the authority application, prescribers should request the appropriate number of vials based on the patient&apos;s weight, as per the TGA approved Product Information. Up to 2 repeats may be requested for initial treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-10-01","Y","4708"
"17404_17405_R","Continuing treatment","STREAMLINED","17405","17404","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven Pseudomonas aeruginosa infection</p><br/><p>Continuing treatment</p><br/><p>Patient must have cystic fibrosis; AND</p> <p>Patient must have previously been issued with an authority prescription for tobramycin inhalation capsules; AND</p> <p>Patient must have demonstrated ability to tolerate the dry powder formulation following the initial 4-week treatment period, as agreed by the patient, the patient''s family (in the case of paediatric patients) and the treating physician(s); AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where patient care is being shared with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven Pseudomonas aeruginosa infection</p><br/><p>Continuing treatment</p><br/><p>Patient must have cystic fibrosis; AND</p> <p>Patient must have previously been issued with an authority prescription for tobramycin inhalation capsules; AND</p> <p>Patient must have demonstrated ability to tolerate the dry powder formulation following the initial 4-week treatment period, as agreed by the patient, the patient''s family (in the case of paediatric patients) and the treating physician(s); AND</p> <p>Patient must be 6 years of age or older; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where patient care is being shared with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17407_17409_R","First continuing treatment - until remission is confirmed","AUTHORITY_REQUIRED","17409","17407","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>First continuing treatment - until remission is confirmed</p><br/><p>Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 36 weeks of treatment under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) gastroenterologist, (ii) surgeon experienced in the management of patients with eosinophilic oesophagitis, (iii) physician experienced in the management of patients with eosinophilic oesophagitis, (iv) a prescriber who is not any of the aforementioned prescriber types, but who has consulted at least one of the aforementioned prescriber types.</p> <p align=""justify"">Histologic assessment should be based on the peak eosinophils count derived, where necessary, from the evaluation of at least eight oesophageal biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction).</p><p align=""justify"">The histologic assessment should, where possible, be performed by, or in consultation with, the same physician or surgeon who confirmed the patient&apos;s diagnosis of eosinophilic oesophagitis. This assessment must be conducted within 48 weeks of initiating treatment to determine the patient&apos;s eligibility for continuing treatment. The histologic assessment should be conducted no later than 2 weeks prior to the patient completing the PBS-subsidised First continuing treatment course to avoid an interruption of supply for continuing therapy. Where a histologic assessment is not undertaken, the patient will not be eligible for ongoing treatment.</p><p align=""justify"">The result of the histological assessment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">First application for the subsequent continuing treatment of this condition must be received within 12 weeks of the histologic assessment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>First continuing treatment - until remission is confirmed</p><br/><p>Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 36 weeks of treatment under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) gastroenterologist, (ii) surgeon experienced in the management of patients with eosinophilic oesophagitis, (iii) physician experienced in the management of patients with eosinophilic oesophagitis, (iv) a prescriber who is not any of the aforementioned prescriber types, but who has consulted at least one of the aforementioned prescriber types.</p> <p align=""justify"">Histologic assessment should be based on the peak eosinophils count derived, where necessary, from the evaluation of at least eight oesophageal biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction).</p><p align=""justify"">The histologic assessment should, where possible, be performed by, or in consultation with, the same physician or surgeon who confirmed the patient&apos;s diagnosis of eosinophilic oesophagitis. This assessment must be conducted within 48 weeks of initiating treatment to determine the patient&apos;s eligibility for continuing treatment. The histologic assessment should be conducted no later than 2 weeks prior to the patient completing the PBS-subsidised First continuing treatment course to avoid an interruption of supply for continuing therapy. Where a histologic assessment is not undertaken, the patient will not be eligible for ongoing treatment.</p><p align=""justify"">The result of the histological assessment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">First application for the subsequent continuing treatment of this condition must be received within 12 weeks of the histologic assessment.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17408_17406_R","Subsequent continuing treatment - Maintenance of remission","AUTHORITY_REQUIRED","17406","17408","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Subsequent continuing treatment - Maintenance of remission</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have documented evidence of having achieved histologic remission while receiving Initial and First continuing PBS-subsidised treatment with this drug for this condition, defined as a peak eosinophil count of less than 5 eosinophils per high power field (hpf), corresponding to less than 16 eosinophils per mm2 hpf on oesophageal biopsy; AND</p> <p>The condition must not have progressed while being treated with this drug; AND</p> <p>Must be treated by a prescriber who is either: (i) gastroenterologist, (ii) surgeon experienced in the management of patients with eosinophilic oesophagitis, (iii) physician experienced in the management of patients with eosinophilic oesophagitis, (iv) a prescriber who is not any of the aforementioned prescriber types, but who has consulted at least one of the aforementioned prescriber types.</p> <p align=""justify"">Histologic assessment should be based on the peak eosinophils count derived, where necessary, from the evaluation of at least eight oesophageal biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction).</p><p align=""justify"">The histologic assessment should, where possible, be performed by, or in consultation with, the same physician or surgeon who confirmed the patient&apos;s diagnosis of eosinophilic oesophagitis. This assessment must be conducted within 48 weeks of initiating treatment to determine the patient&apos;s eligibility for continuing treatment. The histologic assessment should be conducted no later than 2 weeks prior to the patient completing the PBS-subsidised First continuing treatment course to avoid an interruption of supply for continuing therapy. Where a histologic assessment is not undertaken, the patient will not be eligible for ongoing treatment.</p><p align=""justify"">The result of the histological assessment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">First application for the subsequent continuing treatment of this condition must be received within 12 weeks of the histologic assessment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Subsequent continuing treatment - Maintenance of remission</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have documented evidence of having achieved histologic remission while receiving Initial and First continuing PBS-subsidised treatment with this drug for this condition, defined as a peak eosinophil count of less than 5 eosinophils per high power field (hpf), corresponding to less than 16 eosinophils per mm2 hpf on oesophageal biopsy; AND</p> <p>The condition must not have progressed while being treated with this drug; AND</p> <p>Must be treated by a prescriber who is either: (i) gastroenterologist, (ii) surgeon experienced in the management of patients with eosinophilic oesophagitis, (iii) physician experienced in the management of patients with eosinophilic oesophagitis, (iv) a prescriber who is not any of the aforementioned prescriber types, but who has consulted at least one of the aforementioned prescriber types.</p> <p align=""justify"">Histologic assessment should be based on the peak eosinophils count derived, where necessary, from the evaluation of at least eight oesophageal biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction).</p><p align=""justify"">The histologic assessment should, where possible, be performed by, or in consultation with, the same physician or surgeon who confirmed the patient&apos;s diagnosis of eosinophilic oesophagitis. This assessment must be conducted within 48 weeks of initiating treatment to determine the patient&apos;s eligibility for continuing treatment. The histologic assessment should be conducted no later than 2 weeks prior to the patient completing the PBS-subsidised First continuing treatment course to avoid an interruption of supply for continuing therapy. Where a histologic assessment is not undertaken, the patient will not be eligible for ongoing treatment.</p><p align=""justify"">The result of the histological assessment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">First application for the subsequent continuing treatment of this condition must be received within 12 weeks of the histologic assessment.</p>","N","N","N","IMMEDIATE","ALL","N","2025-10-01","N","4708"
"17411_17491_R","Initial treatment as second-line drug therapy for weeks 1 to 9 (administered once weekly)","AUTHORITY_REQUIRED","17491","17411","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Initial treatment as second-line drug therapy for weeks 1 to 9 (administered once weekly)</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must be in combination with bortezomib and dexamethasone; AND</p> <p>Patient must have progressive disease after only one prior therapy (i.e. use must be as second-line drug therapy; use as third-line drug therapy or beyond is not PBS-subsidised); AND</p> <p>Patient must be undergoing PBS-subsidised treatment with this drug once per lifetime. Meaning, patient must access this drug in one of the following situations: (i) for the first time, irrespective of whether the diagnosis has been re-classified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), or irrespective of whether the disease staging has been changed (i.e. disease has changed from untreated multiple myeloma to relapsed or refractory multiple myeloma), (ii) changing the drug''s form (intravenous/subcutaneous) within the first 9 weeks of treatment for the same PBS indication.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient&apos;s medical records.</p><p align=""justify"">Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient&apos;s medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient&apos;s medical records.</p> <p align=""justify"">A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner.</p><p align=""justify"">A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed and/or refractory multiple myeloma</p><br/><p>Initial treatment as second-line drug therapy for weeks 1 to 9 (administered once weekly)</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The treatment must be in combination with bortezomib and dexamethasone; AND</p> <p>Patient must have progressive disease after only one prior therapy (i.e. use must be as second-line drug therapy; use as third-line drug therapy or beyond is not PBS-subsidised); AND</p> <p>Patient must be undergoing PBS-subsidised treatment with this drug once per lifetime. Meaning, patient must access this drug in one of the following situations: (i) for the first time, irrespective of whether the diagnosis has been re-classified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), or irrespective of whether the disease staging has been changed (i.e. disease has changed from untreated multiple myeloma to relapsed or refractory multiple myeloma), (ii) changing the drug''s form (intravenous/subcutaneous) within the first 9 weeks of treatment for the same PBS indication.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient&apos;s medical records.</p><p align=""justify"">Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient&apos;s medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient&apos;s medical records.</p> <p align=""justify"">A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner.</p><p align=""justify"">A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17413_17413_R","Continuing treatment as first line drug therapy from week 25 onwards (administered once every four weeks)","AUTHORITY_REQUIRED","17413","17413","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Untreated multiple myeloma</p><br/><p>Continuing treatment as first line drug therapy from week 25 onwards (administered once every four weeks)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must form part of triple combination therapy limited only to: (i) this drug, (ii) lenalidomide, and (iii) dexamethasone; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with bortezomib, carfilzomib, elotuzumab, pomalidomide, selinexor or thalidomide; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Untreated multiple myeloma</p><br/><p>Continuing treatment as first line drug therapy from week 25 onwards (administered once every four weeks)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must form part of triple combination therapy limited only to: (i) this drug, (ii) lenalidomide, and (iii) dexamethasone; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with bortezomib, carfilzomib, elotuzumab, pomalidomide, selinexor or thalidomide; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17414_17414_R","Triple combination therapy consisting of daratumumab, lenalidomide and dexamethasone","AUTHORITY_REQUIRED","17414","17414","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Untreated multiple myeloma</p><br/><p>Triple combination therapy consisting of daratumumab, lenalidomide and dexamethasone</p><br/><p>Patient must be undergoing concurrent treatment with daratumumab obtained through the PBS for the treatment of transplant ineligible, newly diagnosed multiple myeloma; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Untreated multiple myeloma</p><br/><p>Triple combination therapy consisting of daratumumab, lenalidomide and dexamethasone</p><br/><p>Patient must be undergoing concurrent treatment with daratumumab obtained through the PBS for the treatment of transplant ineligible, newly diagnosed multiple myeloma; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17433_17434_R","Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form","STREAMLINED","17434","17433","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the intravenous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab intravenous form continuing treatment restriction; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed within 4 weeks prior to completing their current course of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the intravenous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab intravenous form continuing treatment restriction; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed within 4 weeks prior to completing their current course of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17439_17440_R","Continuing treatment","AUTHORITY_REQUIRED","17440","17439","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or Refractory Hodgkin lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND</p> <p>Patient must not be suitable for ASCT for this condition; or</p> <p>Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 12 cycles of treatment under this restriction.</p> <p align=""justify"">The treatment must not exceed a total of 16 cycles for this condition in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or Refractory Hodgkin lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND</p> <p>Patient must not be suitable for ASCT for this condition; or</p> <p>Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 12 cycles of treatment under this restriction.</p> <p align=""justify"">The treatment must not exceed a total of 16 cycles for this condition in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17442_17445_R","null","STREAMLINED","17445","17442","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Focal onset seizures</p><br/><p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Focal onset seizures</p><br/><p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17443_17444_R","null","STREAMLINED","17444","17443","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Focal onset seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Focal onset seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17446_17446_R","null","RESTRICTED","17446","17446","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17447_17513_R","null","STREAMLINED","17513","17447","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least two antiseizure medications prior to when the drug is/was first commenced; AND</p> <p>The treatment must be (for initiating treatment)/have been (for continuing treatment) in combination with at least one PBS-subsidised antiseizure medication at the time the drug is/was first commenced.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least two antiseizure medications prior to when the drug is/was first commenced; AND</p> <p>The treatment must be (for initiating treatment)/have been (for continuing treatment) in combination with at least one PBS-subsidised antiseizure medication at the time the drug is/was first commenced.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17448_17449_R","Initial treatment","AUTHORITY_REQUIRED","17449","17448","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Refractory seizures associated with tuberous sclerosis complex</p><br/><p>Initial treatment</p><br/><p>Patient must have a confirmed diagnosis of tuberous sclerosis complex (TSC); AND</p> <p>Patient must be experiencing a minimum of two partial-onset seizures per week; AND</p> <p>The condition must have failed to be controlled satisfactorily at stable doses of at least two antiseizure medications; AND</p> <p>The treatment must be in combination with at least one antiseizure medication; AND</p> <p>Patient must not be a candidate for curative surgery; AND</p> <p>Patient must be at least 2 years of age.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Refractory seizures associated with tuberous sclerosis complex</p><br/><p>Initial treatment</p><br/><p>Patient must have a confirmed diagnosis of tuberous sclerosis complex (TSC); AND</p> <p>Patient must be experiencing a minimum of two partial-onset seizures per week; AND</p> <p>The condition must have failed to be controlled satisfactorily at stable doses of at least two antiseizure medications; AND</p> <p>The treatment must be in combination with at least one antiseizure medication; AND</p> <p>Patient must not be a candidate for curative surgery; AND</p> <p>Patient must be at least 2 years of age.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17450_17451_R","Initial treatment","STREAMLINED","17451","17450","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents; AND</p> <p>The treatment must not be given concomitantly with levetiracetam, except for cross titration.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents; AND</p> <p>The treatment must not be given concomitantly with levetiracetam, except for cross titration.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17453_17452_R","Continuing treatment","STREAMLINED","17452","17453","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be given concomitantly with levetiracetam.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be given concomitantly with levetiracetam.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17454_17517_R","Continuing treatment","STREAMLINED","17517","17454","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17458_17562_R","null","STREAMLINED","17562","17458","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have focal onset seizures; or</p> <p>Patient must have primary generalised tonic-clonic seizures; or</p> <p>Patient must have seizures of the Lennox-Gastaut syndrome; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have focal onset seizures; or</p> <p>Patient must have primary generalised tonic-clonic seizures; or</p> <p>Patient must have seizures of the Lennox-Gastaut syndrome; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17459_17488_R","null","STREAMLINED","17488","17459","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures</p><br/><p>Patient must have focal onset seizures; or</p> <p>Patient must have primary generalised tonic-clonic seizures; or</p> <p>Patient must have seizures of the Lennox-Gastaut syndrome; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Patient must be unable to take a solid dose form of topiramate; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures</p><br/><p>Patient must have focal onset seizures; or</p> <p>Patient must have primary generalised tonic-clonic seizures; or</p> <p>Patient must have seizures of the Lennox-Gastaut syndrome; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Patient must be unable to take a solid dose form of topiramate; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17473_17549_R","Balance of supply for Initial treatment - subcutaneous form","AUTHORITY_REQUIRED","17549","17473","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Balance of supply for Initial treatment - subcutaneous form</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment with subcutaneous form restriction to complete 22 weeks initial treatment (intravenous and subcutaneous inclusive); AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>The treatment must provide no more than the balance of up to 22 weeks treatment available under the Initial treatment - subcutaneous form; AND</p> <p>Patient must be at least 18 years of age.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Balance of supply for Initial treatment - subcutaneous form</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment with subcutaneous form restriction to complete 22 weeks initial treatment (intravenous and subcutaneous inclusive); AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>The treatment must provide no more than the balance of up to 22 weeks treatment available under the Initial treatment - subcutaneous form; AND</p> <p>Patient must be at least 18 years of age.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17474_17531_R","Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form","STREAMLINED","17531","17474","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must have both: (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must have both: (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17475_17502_R","Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form","STREAMLINED","17502","17475","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must have both: (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must have both: (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17476_17477_R","Initial treatment","STREAMLINED","17477","17476","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>Patient must be undergoing combination treatment with PBS-subsidised durvalumab; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must not be suitable for transarterial chemoembolisation; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI); AND</p> <p>Patient must not be undergoing PBS-subsidised treatment with this drug for this indication more than once per lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>Patient must be undergoing combination treatment with PBS-subsidised durvalumab; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must not be suitable for transarterial chemoembolisation; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI); AND</p> <p>Patient must not be undergoing PBS-subsidised treatment with this drug for this indication more than once per lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17479_17512_R","null","RESTRICTED","17512","17479","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17480_17516_R","null","STREAMLINED","17516","17480","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least two antiseizure medications prior to when the drug is/was first commenced; AND</p> <p>The treatment must have been in combination with at least one PBS-subsidised antiseizure medication at the time the drug was first commenced.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least two antiseizure medications prior to when the drug is/was first commenced; AND</p> <p>The treatment must have been in combination with at least one PBS-subsidised antiseizure medication at the time the drug was first commenced.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17482_17560_R","Continuing treatment","STREAMLINED","17560","17482","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17483_17541_R","Initial treatment","STREAMLINED","17541","17483","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents; AND</p> <p>The treatment must be for dose titration purposes.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents; AND</p> <p>The treatment must be for dose titration purposes.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17484_17561_R","Initial treatment","STREAMLINED","17561","17484","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents; AND</p> <p>Patient must be unable to take a solid dose form of this drug; AND</p> <p>The treatment must not be given concomitantly with levetiracetam, except for cross titration.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents; AND</p> <p>Patient must be unable to take a solid dose form of this drug; AND</p> <p>The treatment must not be given concomitantly with levetiracetam, except for cross titration.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17485_17455_R","Continuing treatment","STREAMLINED","17455","17485","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17486_17456_R","null","STREAMLINED","17456","17486","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe myoclonic epilepsy in infancy (Dravet syndrome)</p><br/><p>Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other antiseizure medications; AND</p> <p>The treatment must be as adjunctive therapy to at least two other antiseizure medications; AND</p> <p>Must be treated by a neurologist if treatment is being initiated; or</p> <p>Must be treated by a neurologist if treatment is being continued or re-initiated; or</p> <p>Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe myoclonic epilepsy in infancy (Dravet syndrome)</p><br/><p>Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other antiseizure medications; AND</p> <p>The treatment must be as adjunctive therapy to at least two other antiseizure medications; AND</p> <p>Must be treated by a neurologist if treatment is being initiated; or</p> <p>Must be treated by a neurologist if treatment is being continued or re-initiated; or</p> <p>Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17489_17525_R","null","STREAMLINED","17525","17489","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have focal onset seizures; or</p> <p>Patient must have primary generalised tonic-clonic seizures; or</p> <p>Patient must have seizures of the Lennox-Gastaut syndrome; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Patient must be unable to take a solid dose form of topiramate; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have focal onset seizures; or</p> <p>Patient must have primary generalised tonic-clonic seizures; or</p> <p>Patient must have seizures of the Lennox-Gastaut syndrome; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Patient must be unable to take a solid dose form of topiramate; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17490_17579_R","Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements","AUTHORITY_REQUIRED","17579","17490","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary hyperoxaluria type 1</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 October 2025; AND</p> <p>The condition must be primary hyperoxaluria type 1 confirmed by genetic testing; AND</p> <p>Patient must have undergone treatment with pyridoxine therapy prior to commencing non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have a PH1 allele that is considered not responsive to pyridoxine therapy; or</p> <p>Patient must have been contraindicated for pyridoxine therapy as determined by the treating or consulting clinician prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have had urinary oxalate of at least 0.70 mmol/24 h/1.73 m2 measured by mean 24-h urinary oxalate excretion from a valid 24-h urine collection prior to commencing treatment with this drug for this condition; or</p> <p>Patient must have urinary oxalate:creatinine ratio greater than the upper limit of normal based on age on at least two of three single-void collections during screening prior to commencing treatment with this drug for this condition; or</p> <p>Patient must have, prior to commencing treatment with this drug for this condition, clinical symptoms indicative of hyperoxaluria, such as (i) nephrocalcinosis; (ii) renal stones; (iii) renal impairment; (iv) systemic oxalosis; AND</p> <p>Patient must continue to demonstrate clinical benefit as assessed by the treating physician; AND</p> <p>Patient must not have previously undergone liver transplant for primary hyperoxaluria type 1; AND</p> <p>Must be treated by a nephrologist with experience in the management of hyperoxaluria; or</p> <p>Must be treated by a paediatrician with experience in the management of hyperoxaluria; or</p> <p>Must be treated by an authorised prescriber in consultation with one of the above specialty types.</p> <p align=""justify"">At the time of the authority application, prescribers should request the appropriate number of vials based on the patient&apos;s weight, as per the TGA-approved Product Information.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary hyperoxaluria type 1</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 October 2025; AND</p> <p>The condition must be primary hyperoxaluria type 1 confirmed by genetic testing; AND</p> <p>Patient must have undergone treatment with pyridoxine therapy prior to commencing non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have a PH1 allele that is considered not responsive to pyridoxine therapy; or</p> <p>Patient must have been contraindicated for pyridoxine therapy as determined by the treating or consulting clinician prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have had urinary oxalate of at least 0.70 mmol/24 h/1.73 m2 measured by mean 24-h urinary oxalate excretion from a valid 24-h urine collection prior to commencing treatment with this drug for this condition; or</p> <p>Patient must have urinary oxalate:creatinine ratio greater than the upper limit of normal based on age on at least two of three single-void collections during screening prior to commencing treatment with this drug for this condition; or</p> <p>Patient must have, prior to commencing treatment with this drug for this condition, clinical symptoms indicative of hyperoxaluria, such as (i) nephrocalcinosis; (ii) renal stones; (iii) renal impairment; (iv) systemic oxalosis; AND</p> <p>Patient must continue to demonstrate clinical benefit as assessed by the treating physician; AND</p> <p>Patient must not have previously undergone liver transplant for primary hyperoxaluria type 1; AND</p> <p>Must be treated by a nephrologist with experience in the management of hyperoxaluria; or</p> <p>Must be treated by a paediatrician with experience in the management of hyperoxaluria; or</p> <p>Must be treated by an authorised prescriber in consultation with one of the above specialty types.</p> <p align=""justify"">At the time of the authority application, prescribers should request the appropriate number of vials based on the patient&apos;s weight, as per the TGA-approved Product Information.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","FULL","ALL","N","2025-11-01","Y","4708"
"17499_17499_R","Initial treatment","AUTHORITY_REQUIRED","17499","17499","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary biliary cholangitis (previously known as Primary biliary cirrhosis)</p><br/><p>Initial treatment</p><br/><p>Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing concurrent treatment with ursodeoxycholic acid; or</p> <p>Patient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated; AND</p> <p>Patient must not be undergoing concurrent treatment with obeticholic acid; AND</p> <p>Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance/contraindication to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug; AND</p> <p>Patient must not have/be each of: (i) severe liver disease, (ii) immunocompromised; AND</p> <p>Patient must have an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) prior to initiating treatment with this drug, having accounted for each of: (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of ''normal'', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or</p> <p>Patient must have a total bilirubin level between 1 to 2 times the ULN prior to initiating treatment with this drug, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or</p> <p>Patient must have abnormal readings of at least one of: (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid; or</p> <p>Patient must have experienced an intolerance to obeticholic acid of a severity requiring treatment discontinuation, prior to initiating treatment with this drug; or</p> <p>Patient must have inadequately responded to treatment with obeticholic acid, prior to initiating treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Document and retain in the patient&apos;s medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the &apos;Continuing treatment&apos; restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary biliary cholangitis (previously known as Primary biliary cirrhosis)</p><br/><p>Initial treatment</p><br/><p>Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing concurrent treatment with ursodeoxycholic acid; or</p> <p>Patient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated; AND</p> <p>Patient must not be undergoing concurrent treatment with obeticholic acid; AND</p> <p>Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance/contraindication to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug; AND</p> <p>Patient must not have/be each of: (i) severe liver disease, (ii) immunocompromised; AND</p> <p>Patient must have an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) prior to initiating treatment with this drug, having accounted for each of: (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of ''normal'', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or</p> <p>Patient must have a total bilirubin level between 1 to 2 times the ULN prior to initiating treatment with this drug, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or</p> <p>Patient must have abnormal readings of at least one of: (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid; or</p> <p>Patient must have experienced an intolerance to obeticholic acid of a severity requiring treatment discontinuation, prior to initiating treatment with this drug; or</p> <p>Patient must have inadequately responded to treatment with obeticholic acid, prior to initiating treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Document and retain in the patient&apos;s medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the &apos;Continuing treatment&apos; restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17500_17548_R","Continuing treatment","STREAMLINED","17548","17500","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary biliary cholangitis (previously known as Primary biliary cirrhosis)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; or</p> <p>Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this drug, with treatment having commenced through one of: (i) the ''Initial treatment'' listing, (ii) ''Grandfather'' arrangements; AND</p> <p>Patient must be undergoing concurrent treatment with ursodeoxycholic acid; or</p> <p>Patient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated; AND</p> <p>Patient must not be undergoing concurrent treatment with elafibranor; AND</p> <p>Patient must have achieved an adequate response to this drug, defined as having at least one of: (i) an alkaline phosphate (ALP) level less than 1.67 times the upper limit of normal (ULN), (ii) a reduction in the ALP reading of at least 15% compared to the baseline level provided with the initial authority application, (iii) a total bilirubin level within the normal reference range.</p> <p align=""justify"">The improvement in the qualifying laboratory reading(s) has/have been documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary biliary cholangitis (previously known as Primary biliary cirrhosis)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; or</p> <p>Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this drug, with treatment having commenced through one of: (i) the ''Initial treatment'' listing, (ii) ''Grandfather'' arrangements; AND</p> <p>Patient must be undergoing concurrent treatment with ursodeoxycholic acid; or</p> <p>Patient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated; AND</p> <p>Patient must not be undergoing concurrent treatment with elafibranor; AND</p> <p>Patient must have achieved an adequate response to this drug, defined as having at least one of: (i) an alkaline phosphate (ALP) level less than 1.67 times the upper limit of normal (ULN), (ii) a reduction in the ALP reading of at least 15% compared to the baseline level provided with the initial authority application, (iii) a total bilirubin level within the normal reference range.</p> <p align=""justify"">The improvement in the qualifying laboratory reading(s) has/have been documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17501_17501_R","Continuing treatment","STREAMLINED","17501","17501","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary biliary cholangitis (previously known as Primary biliary cirrhosis)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; or</p> <p>Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this drug, with treatment having commenced through one of: (i) the ''Initial treatment'' listing, (ii) ''Grandfather'' arrangements; AND</p> <p>Patient must be undergoing concurrent treatment with ursodeoxycholic acid; or</p> <p>Patient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated; AND</p> <p>Patient must not be undergoing concurrent treatment with obeticholic acid; AND</p> <p>Patient must have achieved an adequate response to this drug, defined as having at least one of: (i) an alkaline phosphate (ALP) level less than 1.67 times the upper limit of normal (ULN), (ii) a reduction in the ALP reading of at least 15% compared to the baseline level provided with the initial authority application, (iii) a total bilirubin level within the normal reference range.</p> <p align=""justify"">The improvement in the qualifying laboratory reading(s) has/have been documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary biliary cholangitis (previously known as Primary biliary cirrhosis)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; or</p> <p>Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing continuing PBS-subsidised treatment with this drug, with treatment having commenced through one of: (i) the ''Initial treatment'' listing, (ii) ''Grandfather'' arrangements; AND</p> <p>Patient must be undergoing concurrent treatment with ursodeoxycholic acid; or</p> <p>Patient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated; AND</p> <p>Patient must not be undergoing concurrent treatment with obeticholic acid; AND</p> <p>Patient must have achieved an adequate response to this drug, defined as having at least one of: (i) an alkaline phosphate (ALP) level less than 1.67 times the upper limit of normal (ULN), (ii) a reduction in the ALP reading of at least 15% compared to the baseline level provided with the initial authority application, (iii) a total bilirubin level within the normal reference range.</p> <p align=""justify"">The improvement in the qualifying laboratory reading(s) has/have been documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17503_17533_R","Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form","STREAMLINED","17533","17503","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17510_17509_R","null","STREAMLINED","17509","17510","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have focal onset seizures; or</p> <p>Patient must have primary generalised tonic-clonic seizures; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have focal onset seizures; or</p> <p>Patient must have primary generalised tonic-clonic seizures; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17511_17478_R","null","STREAMLINED","17478","17511","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures</p><br/><p>Patient must have focal onset seizures; or</p> <p>Patient must have primary generalised tonic-clonic seizures; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures</p><br/><p>Patient must have focal onset seizures; or</p> <p>Patient must have primary generalised tonic-clonic seizures; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17514_17515_R","Dose titration at the start of therapy, during therapy or to gradually cease treatment","STREAMLINED","17515","17514","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures</p><br/><p>Dose titration at the start of therapy, during therapy or to gradually cease treatment</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by a paediatrician; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least two antiseizure medications prior to when the drug is/was first commenced; AND</p> <p>The treatment must be (for initiating treatment)/have been (for continuing treatment) in combination with at least one PBS-subsidised antiseizure medication at the time the drug is/was first commenced; AND</p> <p>The treatment must be for dose titration purposes.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures</p><br/><p>Dose titration at the start of therapy, during therapy or to gradually cease treatment</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by a paediatrician; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least two antiseizure medications prior to when the drug is/was first commenced; AND</p> <p>The treatment must be (for initiating treatment)/have been (for continuing treatment) in combination with at least one PBS-subsidised antiseizure medication at the time the drug is/was first commenced; AND</p> <p>The treatment must be for dose titration purposes.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17518_17481_R","Continuing treatment","STREAMLINED","17481","17518","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Continuing treatment</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17519_17570_R","Initial treatment","STREAMLINED","17570","17519","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least two antiseizure medications; AND</p> <p>The treatment must be in combination with at least one PBS-subsidised antiseizure medication; AND</p> <p>Patient must be aged 12 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least two antiseizure medications; AND</p> <p>The treatment must be in combination with at least one PBS-subsidised antiseizure medication; AND</p> <p>Patient must be aged 12 years or older.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17523_17457_R","null","AUTHORITY_REQUIRED","17457","17523","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe myoclonic epilepsy in infancy (Dravet syndrome)</p><br/><p>Patient must have (if initiating) generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other antiseizure medications; or</p> <p>Patient must have had (if continuing) generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other antiseizure medications; AND</p> <p>The treatment must be as adjunctive therapy to at least two other antiseizure medications; AND</p> <p>Must be treated by a neurologist if treatment is being initiated; or</p> <p>Must be treated by a neurologist if treatment is being continued or re-initiated; or</p> <p>Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe myoclonic epilepsy in infancy (Dravet syndrome)</p><br/><p>Patient must have (if initiating) generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other antiseizure medications; or</p> <p>Patient must have had (if continuing) generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other antiseizure medications; AND</p> <p>The treatment must be as adjunctive therapy to at least two other antiseizure medications; AND</p> <p>Must be treated by a neurologist if treatment is being initiated; or</p> <p>Must be treated by a neurologist if treatment is being continued or re-initiated; or</p> <p>Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17524_17487_R","null","STREAMLINED","17487","17524","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures</p><br/><p>Patient must have focal onset seizures; or</p> <p>Patient must have primary generalised tonic-clonic seizures; or</p> <p>Patient must have seizures of the Lennox-Gastaut syndrome; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures</p><br/><p>Patient must have focal onset seizures; or</p> <p>Patient must have primary generalised tonic-clonic seizures; or</p> <p>Patient must have seizures of the Lennox-Gastaut syndrome; AND</p> <p>The condition must have failed to be controlled satisfactorily by at least one other antiseizure medication; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17532_17551_R","Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form","STREAMLINED","17551","17532","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; or</p> <p>Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; or</p> <p>Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records and must be no more than 4 weeks old at the time of the authority application.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17535_17505_R","Initial treatment","STREAMLINED","17505","17535","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>Patient must be undergoing combination treatment with tremelimumab for the first dose of treatment; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must not be suitable for transarterial chemoembolisation; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>Patient must be undergoing combination treatment with tremelimumab for the first dose of treatment; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>Patient must not be suitable for transarterial chemoembolisation; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17536_17437_R","Continuing treatment","STREAMLINED","17437","17536","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17537_17507_R","Continuing treatment","AUTHORITY_REQUIRED","17507","17537","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or Refractory Hodgkin lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have undergone a primary autologous stem cell transplant (ASCT) for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 12 cycles of treatment under this restriction.</p> <p align=""justify"">The treatment must not exceed a total of 16 cycles for this condition in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or Refractory Hodgkin lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have undergone a primary autologous stem cell transplant (ASCT) for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 12 cycles of treatment under this restriction.</p> <p align=""justify"">The treatment must not exceed a total of 16 cycles for this condition in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17538_17508_R","Initial treatment","AUTHORITY_REQUIRED","17508","17538","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or Refractory Hodgkin lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND</p> <p>Patient must not be suitable for ASCT for this condition; or</p> <p>Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND</p> <p>Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; or</p> <p>Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND</p> <p>Patient must not receive more than 4 cycles of treatment under this restriction; AND</p> <p>Patient must not have received prior treatment with this drug for this condition; or</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or Refractory Hodgkin lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND</p> <p>Patient must not be suitable for ASCT for this condition; or</p> <p>Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND</p> <p>Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; or</p> <p>Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND</p> <p>Patient must not receive more than 4 cycles of treatment under this restriction; AND</p> <p>Patient must not have received prior treatment with this drug for this condition; or</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17542_17460_R","null","RESTRICTED","17460","17542","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>The treatment must not be given concomitantly with brivaracetam, except for cross titration; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>The treatment must not be given concomitantly with brivaracetam, except for cross titration; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17543_17543_R","null","RESTRICTED","17543","17543","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must not be given concomitantly with brivaracetam, except for cross titration; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must not be given concomitantly with brivaracetam, except for cross titration; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17544_17573_R","null","AUTHORITY_REQUIRED","17573","17544","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be estrogen receptor positive; AND</p> <p>The treatment must be in combination with fulvestrant; AND</p> <p>The treatment must be following progression on at least one endocrine-based regimen in the metastatic setting; or</p> <p>The treatment must be following recurrence on or within 12 months of completing endocrine-based adjuvant therapy.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">Confirm that the following information is documented/retained in the patient&apos;s medical records once only with the first PBS prescription:</p><p align=""justify"">1) Evidence of HER2 negative status (evidence obtained in relation to past PBS treatment is acceptable).</p><p align=""justify"">2) Evidence of HR status.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be estrogen receptor positive; AND</p> <p>The treatment must be in combination with fulvestrant; AND</p> <p>The treatment must be following progression on at least one endocrine-based regimen in the metastatic setting; or</p> <p>The treatment must be following recurrence on or within 12 months of completing endocrine-based adjuvant therapy.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">Confirm that the following information is documented/retained in the patient&apos;s medical records once only with the first PBS prescription:</p><p align=""justify"">1) Evidence of HER2 negative status (evidence obtained in relation to past PBS treatment is acceptable).</p><p align=""justify"">2) Evidence of HR status.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17553_17431_R","Continuing treatment (whole body, or, face/hand/foot) with subcutaneous form or switching from intravenous form to subcutaneous form","STREAMLINED","17431","17553","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment (whole body, or, face/hand/foot) with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must have both: (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where the condition is affecting the whole body, an adequate response to treatment is defined as:</p><p align=""justify"">A Psoriasis Area and Severity Index (PASI) score which is reduced by at least 75%, or, is sustained at this level, when compared with the baseline value for this treatment cycle.</p><p align=""justify"">Where the condition is affecting the face/hand/foot, an adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) A reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or, sustained at this level, as compared to the baseline values. Indicate the rating (0=none, 1=slight) for each of these 3 observations in the authority application for each affected area; or</p><p align=""justify"">(ii) A reduction by at least 75% in the skin area affected, or, sustained at this level, as compared to the baseline value for this treatment cycle.</p><p align=""justify"">All assessment findings must be no more than 1 month old at the time of application. Response assessments must be performed on the same affected area assessed at baseline.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment (whole body, or, face/hand/foot) with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must have both: (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where the condition is affecting the whole body, an adequate response to treatment is defined as:</p><p align=""justify"">A Psoriasis Area and Severity Index (PASI) score which is reduced by at least 75%, or, is sustained at this level, when compared with the baseline value for this treatment cycle.</p><p align=""justify"">Where the condition is affecting the face/hand/foot, an adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) A reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or, sustained at this level, as compared to the baseline values. Indicate the rating (0=none, 1=slight) for each of these 3 observations in the authority application for each affected area; or</p><p align=""justify"">(ii) A reduction by at least 75% in the skin area affected, or, sustained at this level, as compared to the baseline value for this treatment cycle.</p><p align=""justify"">All assessment findings must be no more than 1 month old at the time of application. Response assessments must be performed on the same affected area assessed at baseline.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17556_17504_R","Initial treatment","STREAMLINED","17504","17556","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following: (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy, (iii) durvalumab/tremelimumab combination therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following: (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy, (iii) durvalumab/tremelimumab combination therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17558_17539_R","Continuing treatment","STREAMLINED","17539","17558","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Refractory seizures associated with tuberous sclerosis complex</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have maintained a response to the PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with at least one antiseizure medication; AND</p> <p>Patient must not be a candidate for curative surgery.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Refractory seizures associated with tuberous sclerosis complex</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have maintained a response to the PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with at least one antiseizure medication; AND</p> <p>Patient must not be a candidate for curative surgery.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17559_17577_R","Initial treatment","STREAMLINED","17577","17559","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Initial treatment</p><br/><p>The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents; AND</p> <p>Must be treated by a neurologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Initial treatment</p><br/><p>The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents; AND</p> <p>Must be treated by a neurologist.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17563_17563_R","null","RESTRICTED","17563","17563","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>Patient must be unable to take a solid dose form of levetiracetam; AND</p> <p>The treatment must not be given concomitantly with brivaracetam, except for cross titration; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>Patient must be unable to take a solid dose form of levetiracetam; AND</p> <p>The treatment must not be given concomitantly with brivaracetam, except for cross titration; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17564_17564_R","null","RESTRICTED","17564","17564","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be unable to take a solid dose form of levetiracetam; AND</p> <p>The treatment must not be given concomitantly with brivaracetam, except for cross titration; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epileptic seizures</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be unable to take a solid dose form of levetiracetam; AND</p> <p>The treatment must not be given concomitantly with brivaracetam, except for cross titration; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17567_17567_R","Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements","AUTHORITY_REQUIRED","17567","17567","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary biliary cholangitis (previously known as Primary biliary cirrhosis)</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must have received treatment with this drug for this PBS indication prior to 1 November 2025; AND</p> <p>Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; or</p> <p>Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing concurrent treatment with ursodeoxycholic acid; or</p> <p>Patient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated; AND</p> <p>Patient must not be undergoing concurrent treatment with obeticholic acid; AND</p> <p>Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance/contraindication to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug; AND</p> <p>Patient must not have/be each of: (i) severe liver disease, (ii) immunocompromised; AND</p> <p>Patient must have had, prior to initiating treatment with this drug, an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) having accounted for each of: (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of ''normal'', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or</p> <p>Patient must have had, prior to initiating treatment with this drug, a total bilirubin level between 1 to 2 times the ULN, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or</p> <p>Patient must have had, prior to initiating treatment with this drug, abnormal readings of at least one of: (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid; or</p> <p>Patient must have experienced an intolerance to obeticholic acid of a severity requiring treatment discontinuation, prior to initiating treatment with this drug; or</p> <p>Patient must have had inadequately responded to treatment with obeticholic acid, prior to initiating treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Document and retain in the patient&apos;s medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the &apos;Continuing treatment&apos; restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary biliary cholangitis (previously known as Primary biliary cirrhosis)</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must have received treatment with this drug for this PBS indication prior to 1 November 2025; AND</p> <p>Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; or</p> <p>Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing concurrent treatment with ursodeoxycholic acid; or</p> <p>Patient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated; AND</p> <p>Patient must not be undergoing concurrent treatment with obeticholic acid; AND</p> <p>Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance/contraindication to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug; AND</p> <p>Patient must not have/be each of: (i) severe liver disease, (ii) immunocompromised; AND</p> <p>Patient must have had, prior to initiating treatment with this drug, an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) having accounted for each of: (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of ''normal'', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or</p> <p>Patient must have had, prior to initiating treatment with this drug, a total bilirubin level between 1 to 2 times the ULN, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or</p> <p>Patient must have had, prior to initiating treatment with this drug, abnormal readings of at least one of: (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid; or</p> <p>Patient must have experienced an intolerance to obeticholic acid of a severity requiring treatment discontinuation, prior to initiating treatment with this drug; or</p> <p>Patient must have had inadequately responded to treatment with obeticholic acid, prior to initiating treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Document and retain in the patient&apos;s medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the &apos;Continuing treatment&apos; restriction.</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17568_17498_R","Initial treatment","AUTHORITY_REQUIRED","17498","17568","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary biliary cholangitis (previously known as Primary biliary cirrhosis)</p><br/><p>Initial treatment</p><br/><p>Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing concurrent treatment with ursodeoxycholic acid; or</p> <p>Patient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated; AND</p> <p>Patient must not be undergoing concurrent treatment with elafibranor; AND</p> <p>Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance/contraindication to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug; AND</p> <p>Patient must not have/be each of: (i) severe liver disease, (ii) immunocompromised; AND</p> <p>Patient must have an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) prior to initiating treatment with this drug, having accounted for each of: (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of ''normal'', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or</p> <p>Patient must have a total bilirubin level between 1 to 2 times the ULN prior to initiating treatment with this drug, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or</p> <p>Patient must have abnormal readings of at least one of: (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid; or</p> <p>Patient must have experienced an intolerance to elafibranor of a severity requiring treatment discontinuation, prior to initiating treatment with this drug; or</p> <p>Patient must have inadequately responded to treatment with elafibranor, prior to initiating treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Document and retain in the patient&apos;s medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the &apos;Continuing treatment&apos; restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary biliary cholangitis (previously known as Primary biliary cirrhosis)</p><br/><p>Initial treatment</p><br/><p>Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types; AND</p> <p>Patient must be undergoing concurrent treatment with ursodeoxycholic acid; or</p> <p>Patient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated; AND</p> <p>Patient must not be undergoing concurrent treatment with elafibranor; AND</p> <p>Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug; or</p> <p>Patient must have experienced an intolerance/contraindication to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug; AND</p> <p>Patient must not have/be each of: (i) severe liver disease, (ii) immunocompromised; AND</p> <p>Patient must have an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) prior to initiating treatment with this drug, having accounted for each of: (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of ''normal'', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or</p> <p>Patient must have a total bilirubin level between 1 to 2 times the ULN prior to initiating treatment with this drug, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or</p> <p>Patient must have abnormal readings of at least one of: (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid; or</p> <p>Patient must have experienced an intolerance to elafibranor of a severity requiring treatment discontinuation, prior to initiating treatment with this drug; or</p> <p>Patient must have inadequately responded to treatment with elafibranor, prior to initiating treatment with this drug; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Document and retain in the patient&apos;s medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the &apos;Continuing treatment&apos; restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17569_17552_R","Balance of supply for Initial treatment - subcutaneous form","AUTHORITY_REQUIRED","17552","17569","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Balance of supply for Initial treatment - subcutaneous form</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive); AND</p> <p>The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; AND</p> <p>Patient must be at least 18 years of age.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Balance of supply for Initial treatment - subcutaneous form</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive); AND</p> <p>The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; AND</p> <p>Patient must be at least 18 years of age.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17571_17520_R","Initial treatment","STREAMLINED","17520","17571","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Initial treatment</p><br/><p>Must be treated by a neurologist; AND</p> <p>The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent; AND</p> <p>The condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17572_17521_R","null","AUTHORITY_REQUIRED","17521","17572","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe myoclonic epilepsy in infancy (Dravet syndrome)</p><br/><p>Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other antiseizure medications; AND</p> <p>The treatment must be as adjunctive therapy to at least two other antiseizure medications; AND</p> <p>Must be treated by a neurologist if treatment is being initiated; or</p> <p>Must be treated by a neurologist if treatment is being continued or re-initiated; or</p> <p>Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe myoclonic epilepsy in infancy (Dravet syndrome)</p><br/><p>Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other antiseizure medications; AND</p> <p>The treatment must be as adjunctive therapy to at least two other antiseizure medications; AND</p> <p>Must be treated by a neurologist if treatment is being initiated; or</p> <p>Must be treated by a neurologist if treatment is being continued or re-initiated; or</p> <p>Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17576_17438_R","Initial treatment","AUTHORITY_REQUIRED","17438","17576","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or Refractory Hodgkin lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have undergone a primary autologous stem cell transplant (ASCT); AND</p> <p>Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; or</p> <p>Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND</p> <p>Patient must not receive more than 4 cycles of treatment under this restriction; AND</p> <p>Patient must not have received prior treatment with this drug for this condition; or</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or Refractory Hodgkin lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have undergone a primary autologous stem cell transplant (ASCT); AND</p> <p>Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; or</p> <p>Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND</p> <p>Patient must not receive more than 4 cycles of treatment under this restriction; AND</p> <p>Patient must not have received prior treatment with this drug for this condition; or</p> <p>Patient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17580_17436_R","Continuing treatment","STREAMLINED","17436","17580","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17581_17540_R","Continuing treatment","STREAMLINED","17540","17581","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be unable to take a solid dose form of this drug; AND</p> <p>The treatment must not be given concomitantly with levetiracetam.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable focal onset seizures</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be unable to take a solid dose form of this drug; AND</p> <p>The treatment must not be given concomitantly with levetiracetam.</p>","N","N","N","IMMEDIATE","ALL","N","2025-11-01","N","4708"
"17584_17585_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","17585","17584","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; or</p> <p>Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count; and</p><p align=""justify"">(iii) the name of the antibiotic/s received for two separate courses each of three months; or</p><p align=""justify"">(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.</p><p align=""justify"">The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; or</p> <p>Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count; and</p><p align=""justify"">(iii) the name of the antibiotic/s received for two separate courses each of three months; or</p><p align=""justify"">(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.</p><p align=""justify"">The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17586_17617_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","17617","17586","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial 1 (new patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial 1 (new patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17588_17680_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","17680","17588","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The details of two proposed prescriptions should be submitted with every initial application for this drug.</p><p align=""justify"">Prescribing the 150 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.</p><p align=""justify"">Prescribing the 300 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.</p> <p align=""justify"">This restriction is intended for induction dosing only.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The details of two proposed prescriptions should be submitted with every initial application for this drug.</p><p align=""justify"">Prescribing the 150 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.</p><p align=""justify"">Prescribing the 300 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.</p> <p align=""justify"">This restriction is intended for induction dosing only.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17589_17670_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","17670","17589","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; or</p> <p>Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 16 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count; and</p><p align=""justify"">(iii) the name of the antibiotic/s received for two separate courses each of three months; or</p><p align=""justify"">(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.</p><p align=""justify"">The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The details of two proposed prescriptions should be submitted with every initial application for this drug.</p><p align=""justify"">Prescribing the 150 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.</p><p align=""justify"">Prescribing the 300 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.</p> <p align=""justify"">Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; or</p> <p>Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 16 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count; and</p><p align=""justify"">(iii) the name of the antibiotic/s received for two separate courses each of three months; or</p><p align=""justify"">(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.</p><p align=""justify"">The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The details of two proposed prescriptions should be submitted with every initial application for this drug.</p><p align=""justify"">Prescribing the 150 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.</p><p align=""justify"">Prescribing the 300 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.</p> <p align=""justify"">Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17592_17620_R","First continuing treatment","AUTHORITY_REQUIRED","17620","17592","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>First continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to treatment with this drug for this condition; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hidradenitis Suppurativa Clinical Response (HiSCR) result.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>First continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to treatment with this drug for this condition; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hidradenitis Suppurativa Clinical Response (HiSCR) result.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17593_17663_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","17663","17593","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated a response to treatment with this drug for this condition; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hidradenitis Suppurativa Clinical Response (HiSCR) result.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated a response to treatment with this drug for this condition; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hidradenitis Suppurativa Clinical Response (HiSCR) result.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17597_17646_R","Continuing treatment","AUTHORITY_REQUIRED","17646","17597","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to treatment with this drug for this condition; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hidradenitis Suppurativa Clinical Response (HiSCR) result.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to treatment with this drug for this condition; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hidradenitis Suppurativa Clinical Response (HiSCR) result.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17599_17599_R","Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangement 1 (Complement 5 (C5) inhibitor inexperienced patients)","AUTHORITY_REQUIRED","17599","17599","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangement 1 (Complement 5 (C5) inhibitor inexperienced patients)</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2025; AND</p> <p>Patient must not have received any treatment for this condition prior to commencing non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have had a diagnosis of PNH established by flow cytometry prior to commencing non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have had PNH granulocyte clone size equal to or greater than 10% prior to commencing non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have had a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing non-PBS-subsidised treatment with this drug; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing non-PBS-subsidised treatment with this drug; or</p> <p>Patient must have had chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing non-PBS-subsidised treatment with this drug; or</p> <p>Patient must have had chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing non-PBS-subsidised treatment with this drug; or</p> <p>Patient must have had debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing non-PBS-subsidised treatment with this drug; or</p> <p>Patient must have had a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing non-PBS-subsidised treatment with this drug; or</p> <p>Patient must have had recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing non-PBS-subsidised treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a grandfathered patient must qualify under the Subsequent continuing treatment criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangement 1 (Complement 5 (C5) inhibitor inexperienced patients)</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2025; AND</p> <p>Patient must not have received any treatment for this condition prior to commencing non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have had a diagnosis of PNH established by flow cytometry prior to commencing non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have had PNH granulocyte clone size equal to or greater than 10% prior to commencing non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have had a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing non-PBS-subsidised treatment with this drug; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing non-PBS-subsidised treatment with this drug; or</p> <p>Patient must have had chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing non-PBS-subsidised treatment with this drug; or</p> <p>Patient must have had chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing non-PBS-subsidised treatment with this drug; or</p> <p>Patient must have had debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing non-PBS-subsidised treatment with this drug; or</p> <p>Patient must have had a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing non-PBS-subsidised treatment with this drug; or</p> <p>Patient must have had recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing non-PBS-subsidised treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a grandfathered patient must qualify under the Subsequent continuing treatment criteria.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17600_17623_R","Initial treatment - Initial 2 (switching from a Complement 5 (C5) inhibitor)","AUTHORITY_REQUIRED","17623","17600","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - Initial 2 (switching from a Complement 5 (C5) inhibitor)</p><br/><p>Patient must not have received prior treatment with this drug for this condition; AND</p> <p>Patient must have PNH granulocyte clone size equal to or greater than 10% within the last 3 months; AND</p> <p>Patient must have received treatment with at least one C5 inhibitor for at least 3 months before initiating treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; AND</p> <p>The treatment must be in combination with one PBS-subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - Initial 2 (switching from a Complement 5 (C5) inhibitor)</p><br/><p>Patient must not have received prior treatment with this drug for this condition; AND</p> <p>Patient must have PNH granulocyte clone size equal to or greater than 10% within the last 3 months; AND</p> <p>Patient must have received treatment with at least one C5 inhibitor for at least 3 months before initiating treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; AND</p> <p>The treatment must be in combination with one PBS-subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17604_17606_R","Return from PBS-subsidised eculizumab - induction dose","AUTHORITY_REQUIRED","17606","17604","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Return from PBS-subsidised eculizumab - induction dose</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have received prior PBS-subsidised treatment with eculizumab through the ''Initial treatment - Initial 2 (switching from PBS-subsidised ravulizumab for pregnancy)'' criteria; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, as per the Product Information</p> <p align=""justify"">Patient may qualify under this treatment phase more than once for the purposes of family planning. Where long-term continuing PBS-subsidised treatment with this drug is planned, a &apos;Returning&apos; patient may proceed under the &apos;Subsequent Continuing Treatment&apos; criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Return from PBS-subsidised eculizumab - induction dose</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have received prior PBS-subsidised treatment with eculizumab through the ''Initial treatment - Initial 2 (switching from PBS-subsidised ravulizumab for pregnancy)'' criteria; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, as per the Product Information</p> <p align=""justify"">Patient may qualify under this treatment phase more than once for the purposes of family planning. Where long-term continuing PBS-subsidised treatment with this drug is planned, a &apos;Returning&apos; patient may proceed under the &apos;Subsequent Continuing Treatment&apos; criteria.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17607_17605_R","Initial treatment - Initial 1 (new patient) induction dose","AUTHORITY_REQUIRED","17605","17607","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - Initial 1 (new patient) induction dose</p><br/><p>Patient must not have received prior treatment with this drug for this condition; AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, as per the Product Information</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - Initial 1 (new patient) induction dose</p><br/><p>Patient must not have received prior treatment with this drug for this condition; AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, as per the Product Information</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17608_17609_R","Subsequent Continuing Treatment","AUTHORITY_REQUIRED","17609","17608","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Subsequent Continuing Treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the ''First Continuing Treatment'' or ''Return'' criteria; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient&apos;s weight, as per the Product Information. A maximum of 2 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Subsequent Continuing Treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the ''First Continuing Treatment'' or ''Return'' criteria; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient&apos;s weight, as per the Product Information. A maximum of 2 repeats may be requested.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17612_17634_R","null","STREAMLINED","17634","17612","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align=""justify"">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align=""justify"">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17613_17614_R","Initial treatment","AUTHORITY_REQUIRED","17614","17613","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)</p><br/><p>Initial treatment</p><br/><p>Patient must be symptomatic (despite somatostatin analogues); or</p> <p>Patient must have disease progression; AND</p> <p>The treatment must be as monotherapy.</p> <p align=""justify"">Disease progression must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Patients who have developed progressive disease with any of: (i) everolimus; (ii) cabozantinib are not eligible to receive PBS-subsidised treatment with sunitinib for this condition.</p> <p align=""justify"">Patients who have developed intolerance with any of: (i) everolimus; (ii) cabozantinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised sunitinib.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)</p><br/><p>Initial treatment</p><br/><p>Patient must be symptomatic (despite somatostatin analogues); or</p> <p>Patient must have disease progression; AND</p> <p>The treatment must be as monotherapy.</p> <p align=""justify"">Disease progression must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Patients who have developed progressive disease with any of: (i) everolimus; (ii) cabozantinib are not eligible to receive PBS-subsidised treatment with sunitinib for this condition.</p> <p align=""justify"">Patients who have developed intolerance with any of: (i) everolimus; (ii) cabozantinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised sunitinib.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17615_17660_R","Initial treatment as first-line drug therapy from week 0 to week 24","AUTHORITY_REQUIRED","17660","17615","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Untreated multiple myeloma</p><br/><p>Initial treatment as first-line drug therapy from week 0 to week 24</p><br/><p>The condition must be newly diagnosed; AND</p> <p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must be ineligible for a primary stem cell transplantation; AND</p> <p>The treatment must form part of triple combination therapy limited only to: (i) this drug, (ii) lenalidomide, and (iii) dexamethasone; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with bortezomib, carfilzomib, elotuzumab, pomalidomide, selinexor or thalidomide; AND</p> <p>Patient must be undergoing PBS-subsidised treatment with this drug once per lifetime. Meaning, patient must access this drug in one of the following situations: (i) for the first time, irrespective of whether the diagnosis has been re-classified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), (ii) changing the drug''s form (intravenous/subcutaneous) within the first 24 weeks of treatment for the same PBS indication.</p> <p align=""justify"">Details of the histological diagnosis of multiple myeloma, record of ineligibility for stem cell transplant and confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient&apos;s medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Untreated multiple myeloma</p><br/><p>Initial treatment as first-line drug therapy from week 0 to week 24</p><br/><p>The condition must be newly diagnosed; AND</p> <p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must be ineligible for a primary stem cell transplantation; AND</p> <p>The treatment must form part of triple combination therapy limited only to: (i) this drug, (ii) lenalidomide, and (iii) dexamethasone; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with bortezomib, carfilzomib, elotuzumab, pomalidomide, selinexor or thalidomide; AND</p> <p>Patient must be undergoing PBS-subsidised treatment with this drug once per lifetime. Meaning, patient must access this drug in one of the following situations: (i) for the first time, irrespective of whether the diagnosis has been re-classified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), (ii) changing the drug''s form (intravenous/subcutaneous) within the first 24 weeks of treatment for the same PBS indication.</p> <p align=""justify"">Details of the histological diagnosis of multiple myeloma, record of ineligibility for stem cell transplant and confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient&apos;s medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17616_17616_R","null","STREAMLINED","17616","17616","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent or metastatic nasopharyngeal carcinoma</p><br/><p>Patient must have a WHO performance status of no higher than 2; AND</p> <p>The condition must not be amenable to salvage surgery or radiotherapy; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>The treatment must be commenced in combination with platinum-based chemotherapy (PBC) where the patient has not previously received systemic therapy for this condition in the metastatic setting (i.e. used in combination with PBC for 6 cycles in the first line setting unless intolerance/contraindication is confirmed); or</p> <p>The treatment must be the sole PBS-subsidised therapy at the time of treatment initiation where the condition has progressed following treatment with PBC (i.e. used as monotherapy in the second line setting); AND</p> <p>Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 cumulative months from treatment initiation; annotate any remaining repeat prescriptions with the word ''cancelled'' where this occurs.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">An increase above the listed maximum amount may only be requested when a dose of 3 mg/kg every 2 weeks is prescribed in the second line setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent or metastatic nasopharyngeal carcinoma</p><br/><p>Patient must have a WHO performance status of no higher than 2; AND</p> <p>The condition must not be amenable to salvage surgery or radiotherapy; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>The treatment must be commenced in combination with platinum-based chemotherapy (PBC) where the patient has not previously received systemic therapy for this condition in the metastatic setting (i.e. used in combination with PBC for 6 cycles in the first line setting unless intolerance/contraindication is confirmed); or</p> <p>The treatment must be the sole PBS-subsidised therapy at the time of treatment initiation where the condition has progressed following treatment with PBC (i.e. used as monotherapy in the second line setting); AND</p> <p>Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 cumulative months from treatment initiation; annotate any remaining repeat prescriptions with the word ''cancelled'' where this occurs.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">An increase above the listed maximum amount may only be requested when a dose of 3 mg/kg every 2 weeks is prescribed in the second line setting.</p>","N","N","N","IMMEDIATE","ALL","Y","2025-12-01","N","4708"
"17618_17590_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","17590","17618","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The details of two proposed prescriptions should be submitted with every initial application for this drug.</p><p align=""justify"">Prescribing the 150 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.</p><p align=""justify"">Prescribing the 300 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The details of two proposed prescriptions should be submitted with every initial application for this drug.</p><p align=""justify"">Prescribing the 150 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.</p><p align=""justify"">Prescribing the 300 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17619_17591_R","Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements","AUTHORITY_REQUIRED","17591","17619","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2025; AND</p> <p>Patient must have had a Hurley stage II or III with an abscess and inflammatory nodule (AN) count greater than or equal to 3 prior to starting treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to treatment by achieving Hidradenitis Suppurativa Clinical Response (HiSCR) after 12 weeks of treatment if the patient has been treated with this drug for this condition for 12 weeks or longer; AND</p> <p>Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Assessment of disease severity must not have been more than 4 weeks old at the time treatment with this drug was initiated.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count; and</p><p align=""justify"">(iii) the name of the antibiotic/s received; or</p><p align=""justify"">(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal. The name of the one course of antibiotics must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal.</p><p align=""justify"">(v) the Hidradenitis Suppurativa Clinical Response (HiSCR) result if the patient has received 12 weeks or more of treatment.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p>A patient may qualify for PBS-subsidised treatment under this restriction once only.</p> <p align=""left"">For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2025; AND</p> <p>Patient must have had a Hurley stage II or III with an abscess and inflammatory nodule (AN) count greater than or equal to 3 prior to starting treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to treatment by achieving Hidradenitis Suppurativa Clinical Response (HiSCR) after 12 weeks of treatment if the patient has been treated with this drug for this condition for 12 weeks or longer; AND</p> <p>Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Assessment of disease severity must not have been more than 4 weeks old at the time treatment with this drug was initiated.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count; and</p><p align=""justify"">(iii) the name of the antibiotic/s received; or</p><p align=""justify"">(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal. The name of the one course of antibiotics must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal.</p><p align=""justify"">(v) the Hidradenitis Suppurativa Clinical Response (HiSCR) result if the patient has received 12 weeks or more of treatment.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p>A patient may qualify for PBS-subsidised treatment under this restriction once only.</p> <p align=""left"">For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17621_17594_R","Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","17594","17621","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have had 3 treatment failures within this treatment cycle to PBS-subsidised biological medicines for this condition; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The details of two proposed prescriptions should be submitted with every initial application for this drug.</p><p align=""justify"">Prescribing the 150 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.</p><p align=""justify"">Prescribing the 300 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have had 3 treatment failures within this treatment cycle to PBS-subsidised biological medicines for this condition; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The details of two proposed prescriptions should be submitted with every initial application for this drug.</p><p align=""justify"">Prescribing the 150 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.</p><p align=""justify"">Prescribing the 300 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17624_17673_R","Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan or iptacopan for pregnancy (induction doses)","AUTHORITY_REQUIRED","17673","17624","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan or iptacopan for pregnancy (induction doses)</p><br/><p>Patient must be planning pregnancy; or</p> <p>Patient must be pregnant; AND</p> <p>Patient must have received PBS-subsidised treatment with either: (i) pegcetacoplan, (ii) iptacopan for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS-subsidised treatment, a &apos;Switching&apos; patient must proceed under the &apos;Subsequent Continuing Treatment&apos; criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan or iptacopan for pregnancy (induction doses)</p><br/><p>Patient must be planning pregnancy; or</p> <p>Patient must be pregnant; AND</p> <p>Patient must have received PBS-subsidised treatment with either: (i) pegcetacoplan, (ii) iptacopan for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS-subsidised treatment, a &apos;Switching&apos; patient must proceed under the &apos;Subsequent Continuing Treatment&apos; criteria.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17625_17693_R","Subsequent Continuing Treatment","AUTHORITY_REQUIRED","17693","17625","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Subsequent Continuing Treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the ''First Continuing Treatment'' or ''Switch'' criteria; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Subsequent Continuing Treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the ''First Continuing Treatment'' or ''Switch'' criteria; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17627_17676_R","Continuing treatment","AUTHORITY_REQUIRED","17676","17627","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided on the first continuing authority application:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided on the first continuing authority application:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17628_17631_R","Grandfather (transition from non-PBS-subsidised treatment)","AUTHORITY_REQUIRED","17631","17628","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Grandfather (transition from non-PBS-subsidised treatment)</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 March 2022; AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with ravulizumab; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with ravulizumab; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with ravulizumab; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with ravulizumab; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with ravulizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with ravulizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with ravulizumab; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient&apos;s weight, as per the Product Information. A maximum of 2 repeats may be requested.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Grandfather (transition from non-PBS-subsidised treatment)</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 March 2022; AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with ravulizumab; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with ravulizumab; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with ravulizumab; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with ravulizumab; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with ravulizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with ravulizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with ravulizumab; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient&apos;s weight, as per the Product Information. A maximum of 2 repeats may be requested.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5</p> <p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;First Continuing Treatment&apos; criteria.</p> <p align=""justify"">This grandfather restriction will cease to operate from 5 years after the date specified in the clinical criteria.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17632_17610_R","Initial treatment - Initial 2 (switch from LSDP eculizumab) induction dose","AUTHORITY_REQUIRED","17610","17632","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - Initial 2 (switch from LSDP eculizumab) induction dose</p><br/><p>Patient must have previously received eculizumab for the treatment of this condition funded under the Australian Government''s Life Saving Drugs Program (LSDP); AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry prior to LSDP-funded treatment with eculizumab; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to LSDP-funded treatment with eculizumab; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to LSDP-funded treatment with eculizumab; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to LSDP-funded treatment with eculizumab; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to LSDP-funded treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to LSDP-funded treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to LSDP-funded treatment with eculizumab; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, as per the Product Information</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - Initial 2 (switch from LSDP eculizumab) induction dose</p><br/><p>Patient must have previously received eculizumab for the treatment of this condition funded under the Australian Government''s Life Saving Drugs Program (LSDP); AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry prior to LSDP-funded treatment with eculizumab; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to LSDP-funded treatment with eculizumab; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to LSDP-funded treatment with eculizumab; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to LSDP-funded treatment with eculizumab; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to LSDP-funded treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to LSDP-funded treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to LSDP-funded treatment with eculizumab; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to LSDP-funded treatment with eculizumab; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, as per the Product Information</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17633_17611_R","Initial treatment","STREAMLINED","17611","17633","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) or extra-pancreatic neuroendocrine tumour (epNET)</p><br/><p>Initial treatment</p><br/><p>Patient must not have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have progressive disease according to Response Evaluation Criteria in Solid Tumours (RECIST) following at least one prior systemic therapy other than a somatostatin analogue for this indication prior to initiating treatment with this drug; AND</p> <p>Patient must have had a WHO performance status score of no greater than 2 at treatment initiation with this drug; AND</p> <p>Patient must not be undergoing treatment with this drug more than once per lifetime.</p> <p align=""justify"">Patients who develop disease progression while receiving PBS-subsidised treatment with cabozantinib for this condition are not eligible to receive subsequent PBS-subsidised treatment with any of: (i) sunitinib, (ii) everolimus.</p> <p align=""justify"">Patients who develop intolerance while receiving PBS-subsidised treatment with cabozantinib are eligible to receive subsequent PBS-subsidised treatment with any of: (i) sunitinib, (ii) everolimus.</p> <p align=""justify"">Disease progression must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) or extra-pancreatic neuroendocrine tumour (epNET)</p><br/><p>Initial treatment</p><br/><p>Patient must not have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have progressive disease according to Response Evaluation Criteria in Solid Tumours (RECIST) following at least one prior systemic therapy other than a somatostatin analogue for this indication prior to initiating treatment with this drug; AND</p> <p>Patient must have had a WHO performance status score of no greater than 2 at treatment initiation with this drug; AND</p> <p>Patient must not be undergoing treatment with this drug more than once per lifetime.</p> <p align=""justify"">Patients who develop disease progression while receiving PBS-subsidised treatment with cabozantinib for this condition are not eligible to receive subsequent PBS-subsidised treatment with any of: (i) sunitinib, (ii) everolimus.</p> <p align=""justify"">Patients who develop intolerance while receiving PBS-subsidised treatment with cabozantinib are eligible to receive subsequent PBS-subsidised treatment with any of: (i) sunitinib, (ii) everolimus.</p> <p align=""justify"">Disease progression must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17639_17636_R","Continuing treatment","STREAMLINED","17636","17639","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) or extra-pancreatic neuroendocrine tumour (epNET)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not be undergoing treatment with this drug more than once per lifetime.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">Patients who develop disease progression while receiving PBS-subsidised treatment with cabozantinib for this condition are not eligible to receive subsequent PBS-subsidised treatment with any of: (i) sunitinib, (ii) everolimus.</p> <p align=""justify"">Patients who develop intolerance while receiving PBS-subsidised treatment with cabozantinib are eligible to receive subsequent PBS-subsidised treatment with any of: (i) sunitinib, (ii) everolimus.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) or extra-pancreatic neuroendocrine tumour (epNET)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not be undergoing treatment with this drug more than once per lifetime.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">Patients who develop disease progression while receiving PBS-subsidised treatment with cabozantinib for this condition are not eligible to receive subsequent PBS-subsidised treatment with any of: (i) sunitinib, (ii) everolimus.</p> <p align=""justify"">Patients who develop intolerance while receiving PBS-subsidised treatment with cabozantinib are eligible to receive subsequent PBS-subsidised treatment with any of: (i) sunitinib, (ii) everolimus.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17640_7459_R","Continuing treatment beyond 3 months","STREAMLINED","7459","17640","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) soft tissue sarcoma</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>Patient must require dose adjustment; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) soft tissue sarcoma</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>Patient must require dose adjustment; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17642_17587_R","Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","17587","17642","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have had 3 treatment failures within this treatment cycle to PBS-subsidised biological medicines for this condition; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial 1 (new patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have had 3 treatment failures within this treatment cycle to PBS-subsidised biological medicines for this condition; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial 1 (new patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17645_17595_R","Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","17595","17645","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17648_17683_R","Return from PBS-subsidised eculizumab post pregnancy or from one of the PBS-subsidised therapies for this condition, for reasons other than post pregnancy","AUTHORITY_REQUIRED","17683","17648","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Return from PBS-subsidised eculizumab post pregnancy or from one of the PBS-subsidised therapies for this condition, for reasons other than post pregnancy</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have received prior PBS-subsidised treatment with eculizumab through the ''Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan or iptacopan for pregnancy (induction doses)'' criteria; or</p> <p>Patient must have received prior PBS-subsidised treatment with at least one drug listed for this condition and must be returning to pegcetacoplan treatment for reasons other than post pregnancy; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>The treatment must be in combination with one PBS-subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p> <p align=""justify"">For the purposes of family planning, patient may qualify under this treatment phase more than once. To return to pegcetacoplan treatment for reasons other than post pregnancy, patient may qualify under this treatment phase once only in any 12 consecutive months. Where long-term continuing PBS-subsidised treatment with pegcetacoplan is planned, a &apos;Returning&apos; patient must proceed under the &apos;Subsequent Continuing Treatment&apos; criteria of pegcetacoplan.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Return from PBS-subsidised eculizumab post pregnancy or from one of the PBS-subsidised therapies for this condition, for reasons other than post pregnancy</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have received prior PBS-subsidised treatment with eculizumab through the ''Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan or iptacopan for pregnancy (induction doses)'' criteria; or</p> <p>Patient must have received prior PBS-subsidised treatment with at least one drug listed for this condition and must be returning to pegcetacoplan treatment for reasons other than post pregnancy; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>The treatment must be in combination with one PBS-subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p> <p align=""justify"">For the purposes of family planning, patient may qualify under this treatment phase more than once. To return to pegcetacoplan treatment for reasons other than post pregnancy, patient may qualify under this treatment phase once only in any 12 consecutive months. Where long-term continuing PBS-subsidised treatment with pegcetacoplan is planned, a &apos;Returning&apos; patient must proceed under the &apos;Subsequent Continuing Treatment&apos; criteria of pegcetacoplan.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17649_17684_R","Initial treatment - initial 1 (new patient) induction doses","AUTHORITY_REQUIRED","17684","17649","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - initial 1 (new patient) induction doses</p><br/><p>Patient must not have received prior treatment with this drug for this condition; AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - initial 1 (new patient) induction doses</p><br/><p>Patient must not have received prior treatment with this drug for this condition; AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17650_17626_R","Grandfather 1 (transition from non-PBS-subsidised treatment) - maintenance phase","AUTHORITY_REQUIRED","17626","17650","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Grandfather 1 (transition from non-PBS-subsidised treatment) - maintenance phase</p><br/><p>Patient must have received non-PBS-subsidised eculizumab for this condition prior to 1 March 2022; AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Grandfather 1 (transition from non-PBS-subsidised treatment) - maintenance phase</p><br/><p>Patient must have received non-PBS-subsidised eculizumab for this condition prior to 1 March 2022; AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5</p> <p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;First Continuing Treatment&apos; criteria.</p> <p align=""justify"">This grandfather restriction will cease to operate from 5 years after the date specified in the clinical criteria.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17652_17630_R","Switching from PBS-subsidised pegcetacoplan or iptacopan - induction doses","AUTHORITY_REQUIRED","17630","17652","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Switching from PBS-subsidised pegcetacoplan or iptacopan - induction doses</p><br/><p>Patient must have received PBS-subsidised treatment with either: (i) pegcetacoplan, (ii) iptacopan for this condition; AND</p> <p>Patient must have developed resistance or intolerance to either: (i) pegcetacoplan, (ii) iptacopan; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">For continuing PBS-subsidised treatment with this drug, a &apos;Returning&apos; patient must proceed under the<i>&apos;</i>Subsequent Continuing Treatment&apos; criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Switching from PBS-subsidised pegcetacoplan or iptacopan - induction doses</p><br/><p>Patient must have received PBS-subsidised treatment with either: (i) pegcetacoplan, (ii) iptacopan for this condition; AND</p> <p>Patient must have developed resistance or intolerance to either: (i) pegcetacoplan, (ii) iptacopan; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">For continuing PBS-subsidised treatment with this drug, a &apos;Returning&apos; patient must proceed under the<i>&apos;</i>Subsequent Continuing Treatment&apos; criteria.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17653_17651_R","Initial treatment - Initial 2 (switching from PBS-subsidised ravulizumab for pregnancy)","AUTHORITY_REQUIRED","17651","17653","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - Initial 2 (switching from PBS-subsidised ravulizumab for pregnancy)</p><br/><p>Patient must be planning pregnancy; or</p> <p>Patient must be pregnant; AND</p> <p>Patient must have received PBS-subsidised treatment with ravulizumab for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS-subsidised treatment, a &apos;Switching&apos; patient must proceed under the &apos;Subsequent Continuing Treatment&apos; criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - Initial 2 (switching from PBS-subsidised ravulizumab for pregnancy)</p><br/><p>Patient must be planning pregnancy; or</p> <p>Patient must be pregnant; AND</p> <p>Patient must have received PBS-subsidised treatment with ravulizumab for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS-subsidised treatment, a &apos;Switching&apos; patient must proceed under the &apos;Subsequent Continuing Treatment&apos; criteria.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17654_17602_R","Grandfather 2 (transition from LSDP-funded eculizumab)","AUTHORITY_REQUIRED","17602","17654","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Grandfather 2 (transition from LSDP-funded eculizumab)</p><br/><p>Patient must have previously received eculizumab for the treatment of this condition funded under the Australian Government''s Life Saving Drugs Program (LSDP); AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Grandfather 2 (transition from LSDP-funded eculizumab)</p><br/><p>Patient must have previously received eculizumab for the treatment of this condition funded under the Australian Government''s Life Saving Drugs Program (LSDP); AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5</p> <p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;First Continuing Treatment&apos; criteria.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17655_17629_R","First Continuing Treatment","AUTHORITY_REQUIRED","17629","17655","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>First Continuing Treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition under the ''Initial'' or ''Grandfather'' treatment restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient&apos;s weight, as per the Product Information. A maximum of 2 repeats may be requested.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>First Continuing Treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition under the ''Initial'' or ''Grandfather'' treatment restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient&apos;s weight, as per the Product Information. A maximum of 2 repeats may be requested.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17656_4837_R","Continuing treatment","AUTHORITY_REQUIRED","4837","17656","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must not have disease progression; AND</p> <p>The treatment must be as monotherapy.</p> <p align=""justify"">Patients who have progressive disease with this drug are no longer eligible for PBS-subsidised treatment with this drug.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must not have disease progression; AND</p> <p>The treatment must be as monotherapy.</p> <p align=""justify"">Patients who have progressive disease with this drug are no longer eligible for PBS-subsidised treatment with this drug.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17657_17638_R","Initial treatment","STREAMLINED","17638","17657","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting; AND</p> <p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align=""justify"">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; or</p> <p>Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting; AND</p> <p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align=""justify"">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17658_17696_R","Continuing treatment","STREAMLINED","17696","17658","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align=""justify"">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align=""justify"">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17659_7458_R","Continuing treatment beyond 3 months","STREAMLINED","7458","17659","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) soft tissue sarcoma</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) soft tissue sarcoma</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17662_17644_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","17644","17662","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; or</p> <p>Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 16 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count; and</p><p align=""justify"">(iii) the name of the antibiotic/s received for two separate courses each of three months; or</p><p align=""justify"">(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.</p><p align=""justify"">The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">This restriction is intended for induction dosing only.</p> <p align=""justify"">The details of two proposed prescriptions should be submitted with every initial application for this drug.</p><p align=""justify"">Prescribing the 150 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.</p><p align=""justify"">Prescribing the 300 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.</p> <p align=""justify"">Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; or</p> <p>Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 16 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count; and</p><p align=""justify"">(iii) the name of the antibiotic/s received for two separate courses each of three months; or</p><p align=""justify"">(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.</p><p align=""justify"">The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">This restriction is intended for induction dosing only.</p> <p align=""justify"">The details of two proposed prescriptions should be submitted with every initial application for this drug.</p><p align=""justify"">Prescribing the 150 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.</p><p align=""justify"">Prescribing the 300 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.</p> <p align=""justify"">Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17664_17666_R","Return from PBS-subsidised eculizumab post pregnancy or from PBS-subsidised Complement 5 (C5) inhibitor for reasons other than post pregnancy","AUTHORITY_REQUIRED","17666","17664","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Return from PBS-subsidised eculizumab post pregnancy or from PBS-subsidised Complement 5 (C5) inhibitor for reasons other than post pregnancy</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have received prior PBS-subsidised treatment with eculizumab through the ''Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan or iptacopan for pregnancy (induction doses)'' criteria; or</p> <p>Patient must have received prior PBS-subsidised treatment with at least one C5 inhibitor and must be returning to iptacopan treatment for reasons other than post pregnancy; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p> <p align=""justify"">Patients may qualify under this treatment phase more than once.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Return from PBS-subsidised eculizumab post pregnancy or from PBS-subsidised Complement 5 (C5) inhibitor for reasons other than post pregnancy</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have received prior PBS-subsidised treatment with eculizumab through the ''Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan or iptacopan for pregnancy (induction doses)'' criteria; or</p> <p>Patient must have received prior PBS-subsidised treatment with at least one C5 inhibitor and must be returning to iptacopan treatment for reasons other than post pregnancy; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p> <p align=""justify"">Patients may qualify under this treatment phase more than once.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17665_17603_R","Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements","AUTHORITY_REQUIRED","17603","17665","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2025; AND</p> <p>Patient must have a documented PNH granulocyte clone size equal to or greater than 10% within the 3 months prior to initiating non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have experienced an inadequate response to a complement 5 (C5) inhibitor demonstrated by a haemoglobin level of less than 105 g/L prior to initiating non-PBS-subsidised treatment with this drug; or</p> <p>Patient must be intolerant to C5 inhibitors as determined by the treating physician prior to initiating non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have been receiving treatment with at least one C5 inhibitor for at least 3 months prior to initiating non-PBS-subsidised treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2025; AND</p> <p>Patient must have a documented PNH granulocyte clone size equal to or greater than 10% within the 3 months prior to initiating non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have experienced an inadequate response to a complement 5 (C5) inhibitor demonstrated by a haemoglobin level of less than 105 g/L prior to initiating non-PBS-subsidised treatment with this drug; or</p> <p>Patient must be intolerant to C5 inhibitors as determined by the treating physician prior to initiating non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have been receiving treatment with at least one C5 inhibitor for at least 3 months prior to initiating non-PBS-subsidised treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17667_17637_R","null","STREAMLINED","17637","17667","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align=""justify"">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align=""justify"">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17668_17679_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","17679","17668","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; or</p> <p>Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial 1 (new patient) or Initial 2 (recommencement of treatment) - balance of supply</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count; and</p><p align=""justify"">(iii) the name of the antibiotic/s received for two separate courses each of three months; or</p><p align=""justify"">(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.</p><p align=""justify"">The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; or</p> <p>Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial 1 (new patient) or Initial 2 (recommencement of treatment) - balance of supply</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count; and</p><p align=""justify"">(iii) the name of the antibiotic/s received for two separate courses each of three months; or</p><p align=""justify"">(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.</p><p align=""justify"">The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17669_17643_R","Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years), or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","17643","17669","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years), or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years), or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment; AND</p> <p>Must be treated by a dermatologist.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17672_17622_R","Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangement 2 (Complement 5 (C5) inhibitor experienced patients)","AUTHORITY_REQUIRED","17622","17672","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangement 2 (Complement 5 (C5) inhibitor experienced patients)</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2025; AND</p> <p>Patient must have had PNH granulocyte clone size equal to or greater than 10% within the last 3 months prior to commencing non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have received treatment with at least one C5 inhibitor for at least 3 months before initiating non-PBS-subsidised treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; AND</p> <p>The treatment must have been in combination with one C5 inhibitor for a period of 4 weeks during initiation of therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a grandfathered patient must qualify under the Subsequent continuing treatment criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangement 2 (Complement 5 (C5) inhibitor experienced patients)</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2025; AND</p> <p>Patient must have had PNH granulocyte clone size equal to or greater than 10% within the last 3 months prior to commencing non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have received treatment with at least one C5 inhibitor for at least 3 months before initiating non-PBS-subsidised treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; AND</p> <p>The treatment must have been in combination with one C5 inhibitor for a period of 4 weeks during initiation of therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a grandfathered patient must qualify under the Subsequent continuing treatment criteria.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17674_17601_R","Initial treatment - Initial 1 (new untreated patient)","AUTHORITY_REQUIRED","17601","17674","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - Initial 1 (new untreated patient)</p><br/><p>Patient must not have received prior treatment with any of the PBS-subsidised therapies listed for this condition; AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry; AND</p> <p>Patient must have PNH granulocyte clone size equal to or greater than 10%; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment - Initial 1 (new untreated patient)</p><br/><p>Patient must not have received prior treatment with any of the PBS-subsidised therapies listed for this condition; AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry; AND</p> <p>Patient must have PNH granulocyte clone size equal to or greater than 10%; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17678_17678_R","null","STREAMLINED","17678","17678","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures of the Lennox-Gastaut syndrome</p><br/><p>Patient must have a diagnosis of Lennox-Gastaut syndrome; the diagnosis should be confirmed by an electroencephalogram (EEG) where possible; AND</p> <p>Patient must have (as an initiating patient)/have had (as a continuing patient) more than one type of seizure that is not adequately controlled with at least two other antiseizure medications prior to initiating treatment with this medicine; AND</p> <p>The treatment must be as adjunctive therapy to other antiseizure medication; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist, (ii) a paediatrician if treatment is being initiated; or</p> <p>Must be treated by a prescriber who is either: (i) a neurologist, (ii) a paediatrician if treatment is being continued or re-initiated; or</p> <p>Must be treated by a general practitioner in consultation with either: (i) a neurologist, (ii) a paediatrician if treatment is being continued.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Seizures of the Lennox-Gastaut syndrome</p><br/><p>Patient must have a diagnosis of Lennox-Gastaut syndrome; the diagnosis should be confirmed by an electroencephalogram (EEG) where possible; AND</p> <p>Patient must have (as an initiating patient)/have had (as a continuing patient) more than one type of seizure that is not adequately controlled with at least two other antiseizure medications prior to initiating treatment with this medicine; AND</p> <p>The treatment must be as adjunctive therapy to other antiseizure medication; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist, (ii) a paediatrician if treatment is being initiated; or</p> <p>Must be treated by a prescriber who is either: (i) a neurologist, (ii) a paediatrician if treatment is being continued or re-initiated; or</p> <p>Must be treated by a general practitioner in consultation with either: (i) a neurologist, (ii) a paediatrician if treatment is being continued.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17682_17647_R","First continuing treatment","AUTHORITY_REQUIRED","17647","17682","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>First continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition under ''Initial 1'' (new untreated patient) or ''Initial 2'' (switching from a Complement 5 (C5) inhibitor); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>First continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition under ''Initial 1'' (new untreated patient) or ''Initial 2'' (switching from a Complement 5 (C5) inhibitor); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17685_17697_R","First Continuing Treatment","AUTHORITY_REQUIRED","17697","17685","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>First Continuing Treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition under an ''Initial'', ''Balance of Supply'', or ''Grandfather'' treatment criteria; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>First Continuing Treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug for this condition under an ''Initial'', ''Balance of Supply'', or ''Grandfather'' treatment criteria; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17686_17675_R","Balance of Supply (transition from non-PBS-subsidised treatment during induction phase)","AUTHORITY_REQUIRED","17675","17686","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Balance of Supply (transition from non-PBS-subsidised treatment during induction phase)</p><br/><p>Patient must have received non-PBS-subsidised eculizumab for this condition prior to 1 March 2022; AND</p> <p>Patient must have received insufficient quantity to complete the induction treatment phase; AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials to complete the induction treatment phase, as per the Product Information.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Balance of Supply (transition from non-PBS-subsidised treatment during induction phase)</p><br/><p>Patient must have received non-PBS-subsidised eculizumab for this condition prior to 1 March 2022; AND</p> <p>Patient must have received insufficient quantity to complete the induction treatment phase; AND</p> <p>Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND</p> <p>Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND</p> <p>Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND</p> <p>Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; or</p> <p>Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; or</p> <p>Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; or</p> <p>Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or</p> <p>Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or</p> <p>Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials to complete the induction treatment phase, as per the Product Information.</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17687_17635_R","null","STREAMLINED","17635","17687","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align=""justify"">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)</p><br/><p>The condition must be unresectable locally advanced disease or metastatic disease; AND</p> <p>The condition must be World Health Organisation (WHO) grade 1 or 2; AND</p> <p>The treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.</p> <p align=""justify"">WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17688_7459_R","Continuing treatment beyond 3 months","STREAMLINED","7459","17688","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) soft tissue sarcoma</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>Patient must require dose adjustment; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) soft tissue sarcoma</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>Patient must require dose adjustment; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17689_17671_R","Continuing treatment","AUTHORITY_REQUIRED","17671","17689","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to treatment with this drug for this condition; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hidradenitis Suppurativa Clinical Response (HiSCR) result.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to treatment with this drug for this condition; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hidradenitis Suppurativa Clinical Response (HiSCR) result.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17690_17681_R","Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","17681","17690","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have had 3 treatment failures within this treatment cycle to PBS-subsidised biological medicines for this condition; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The details of two proposed prescriptions should be submitted with every initial application for this drug.</p><p align=""justify"">Prescribing the 150 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.</p><p align=""justify"">Prescribing the 300 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.</p> <p align=""justify"">This restriction is intended for induction dosing only.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have had 3 treatment failures within this treatment cycle to PBS-subsidised biological medicines for this condition; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The details of two proposed prescriptions should be submitted with every initial application for this drug.</p><p align=""justify"">Prescribing the 150 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.</p><p align=""justify"">Prescribing the 300 mg presentation:</p><p align=""justify"">One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.</p> <p align=""justify"">This restriction is intended for induction dosing only.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17691_17596_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","17596","17691","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Assessment of disease severity must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A response to treatment is defined as:</p><p align=""justify"">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) the Hurley stage grading; and</p><p align=""justify"">(ii) the AN count.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription(s); and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17692_17598_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","17598","17692","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the ''First continuing treatment'', ''Return'' criteria, or ''Grandfather'' treatment restrictions; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the ''First continuing treatment'', ''Return'' criteria, or ''Grandfather'' treatment restrictions; AND</p> <p>Patient must have experienced clinical improvement as a result of treatment with this drug; or</p> <p>Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17694_17695_R","Initial treatment (new patient)","AUTHORITY_REQUIRED","17695","17694","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment (new patient)</p><br/><p>Patient must not have received prior treatment with this drug for this condition; AND</p> <p>Patient must have PNH granulocyte clone size equal to or greater than 10% within the last 3 months; AND</p> <p>Patient must have experienced an inadequate response/intolerance to either: (i) Complement 5 (C5) inhibitor, (ii) pegcetacoplan; AND</p> <p>Patient must have received treatment with at least one complement inhibitor for at least 3 months before initiating treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Paroxysmal nocturnal haemoglobinuria (PNH)</p><br/><p>Initial treatment (new patient)</p><br/><p>Patient must not have received prior treatment with this drug for this condition; AND</p> <p>Patient must have PNH granulocyte clone size equal to or greater than 10% within the last 3 months; AND</p> <p>Patient must have experienced an inadequate response/intolerance to either: (i) Complement 5 (C5) inhibitor, (ii) pegcetacoplan; AND</p> <p>Patient must have received treatment with at least one complement inhibitor for at least 3 months before initiating treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a haematologist; or</p> <p>Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient''s drug treatment details; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:</p><p align=""justify"">(i) Haemoglobin (g/L)</p><p align=""justify"">(ii) Platelets (x10<sup>9</sup>/L)</p><p align=""justify"">(iii) White Cell Count (x10<sup>9</sup>/L)</p><p align=""justify"">(iv) Reticulocytes (x10<sup>9</sup>/L)</p><p align=""justify"">(v) Neutrophils (x10<sup>9</sup>/L)</p><p align=""justify"">(vi) Granulocyte clone size (%)</p><p align=""justify"">(vii) Lactate Dehydrogenase (LDH)</p><p align=""justify"">(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory</p><p align=""justify"">(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)</p>","N","N","N","FULL","ALL","N","2025-12-01","Y","4708"
"17698_17677_R","Initial treatment","AUTHORITY_REQUIRED","17677","17698","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)</p><br/><p>Initial treatment</p><br/><p>Patient must be symptomatic (despite somatostatin analogues); or</p> <p>Patient must have disease progression; AND</p> <p>The treatment must be as monotherapy.</p> <p align=""justify"">Disease progression must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Patients who have developed progressive disease with any of: (i) sunitinib; (ii) cabozantinib are not eligible to receive PBS-subsidised everolimus for this condition.</p> <p align=""justify"">Patients who have developed intolerance with any of: (i) sunitinib; (ii) cabozantinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised everolimus.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)</p><br/><p>Initial treatment</p><br/><p>Patient must be symptomatic (despite somatostatin analogues); or</p> <p>Patient must have disease progression; AND</p> <p>The treatment must be as monotherapy.</p> <p align=""justify"">Disease progression must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Patients who have developed progressive disease with any of: (i) sunitinib; (ii) cabozantinib are not eligible to receive PBS-subsidised everolimus for this condition.</p> <p align=""justify"">Patients who have developed intolerance with any of: (i) sunitinib; (ii) cabozantinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised everolimus.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17699_7458_R","Continuing treatment beyond 3 months","STREAMLINED","7458","17699","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) soft tissue sarcoma</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) soft tissue sarcoma</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17700_17661_R","Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements","AUTHORITY_REQUIRED","17661","17700","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Untreated multiple myeloma</p><br/><p>Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2025; AND</p> <p>Patient must have met all initial treatment PBS eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (a) the condition was newly diagnosed, (b) the condition was confirmed by a histological diagnosis, (c) the patient was/is ineligible for a stem cell transplant, (d) the treatment is being given as triple combination therapy limited only to: (i) this drug, (ii) lenalidomide, (iii) dexamethasone, (e) patient is not receiving concomitant PBS-subsidised treatment with bortezomib, carfilzomib, elotuzumab, pomalidomide, selinexor or thalidomide; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must be undergoing PBS-subsidised treatment with this drug once per lifetime. Meaning, patient must access this drug in one of the following situations: (i) for the first time, irrespective of whether the diagnosis has been re-classified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), (ii) changing the drug''s form (intravenous/subcutaneous) within the first 24 weeks of treatment for the same PBS indication.</p> <p align=""justify"">Details of the histological diagnosis of multiple myeloma, record of ineligibility for stem cell transplant and confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient&apos;s medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Untreated multiple myeloma</p><br/><p>Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2025; AND</p> <p>Patient must have met all initial treatment PBS eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (a) the condition was newly diagnosed, (b) the condition was confirmed by a histological diagnosis, (c) the patient was/is ineligible for a stem cell transplant, (d) the treatment is being given as triple combination therapy limited only to: (i) this drug, (ii) lenalidomide, (iii) dexamethasone, (e) patient is not receiving concomitant PBS-subsidised treatment with bortezomib, carfilzomib, elotuzumab, pomalidomide, selinexor or thalidomide; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must be undergoing PBS-subsidised treatment with this drug once per lifetime. Meaning, patient must access this drug in one of the following situations: (i) for the first time, irrespective of whether the diagnosis has been re-classified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), (ii) changing the drug''s form (intravenous/subcutaneous) within the first 24 weeks of treatment for the same PBS indication.</p> <p align=""justify"">Details of the histological diagnosis of multiple myeloma, record of ineligibility for stem cell transplant and confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient&apos;s medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p>Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p> <p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction to complete 24 weeks of treatment. For continuing PBS-subsidised treatment after week 24, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2025-12-01","N","4708"
"17702_17722_R","Dose modification (Dose escalation from initial treatment phase; for PFIC diagnosed after turning 18 years of age)","AUTHORITY_REQUIRED","17722","17702","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive familial intrahepatic cholestasis (PFIC)</p><br/><p>Dose modification (Dose escalation from initial treatment phase; for PFIC diagnosed after turning 18 years of age)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have demonstrated an adequate clinical response after at least 1 month and up to 3 months following commencement of treatment at 40 micrograms/kg/day; AND</p> <p>Patient must be undergoing treatment with this drug for this condition at 120 micrograms/kg/day; AND</p> <p>Must be treated by a specialist hepatologist experienced in the management of progressive familial intrahepatic cholestasis (PFIC); or</p> <p>Must be treated by a medical practitioner under the supervision of a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC).</p> <p align=""justify"">At the time of the authority application, the prescriber should request sufficient quantity and repeats to provide for the balance to complete up to 6 months of treatment (inclusive of initial and dose modification treatment), if dose modification is being accessed following initial treatment.</p> <p align=""justify"">An application for continuing treatment must occur following an assessment of response conducted up to a maximum of 6 months from initiation of therapy. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment 6 months after initiating treatment with this drug for this condition (inclusive of initial and dose modification treatment), they will no longer be eligible to receive PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">An adequate clinical response under this treatment phase is defined as an average of at least 1 grade improvement in pruritus score on the Prucision<sup>TM</sup> ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.</p> <p align=""justify"">Confirmation of eligibility for dose modification treatment must be documented in the patient&apos;s medical records (include assessment of response score after at least 1 month and up to 3 months after commencing initial treatment).</p> <p align=""justify"">Any further authority applications occurring immediately after access through this dose modification listing are not to occur through the initial treatment listing.</p> <p align=""justify""><b>Dose modification</b></p><p align=""justify"">Where the drug&apos;s Product Information indicates variable dosing regimens based on the individual&apos;s response/tolerance, apply under this listing to continue treatment with the new strength. Mark any remaining repeat prescriptions for the discontinued strength with the word &apos;cancelled&apos;. This treatment phase listing recognises that a patient&apos;s optimal dose may not always be immediately apparent at the time of treatment initiation and therefore does not require confirmation of an objective, adequate response to the preceding supply of drug.</p> <p align=""justify"">Eligible patients must not be recommencing treatment directly through this treatment phase.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive familial intrahepatic cholestasis (PFIC)</p><br/><p>Dose modification (Dose escalation from initial treatment phase; for PFIC diagnosed after turning 18 years of age)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have demonstrated an adequate clinical response after at least 1 month and up to 3 months following commencement of treatment at 40 micrograms/kg/day; AND</p> <p>Patient must be undergoing treatment with this drug for this condition at 120 micrograms/kg/day; AND</p> <p>Must be treated by a specialist hepatologist experienced in the management of progressive familial intrahepatic cholestasis (PFIC); or</p> <p>Must be treated by a medical practitioner under the supervision of a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC).</p> <p align=""justify"">At the time of the authority application, the prescriber should request sufficient quantity and repeats to provide for the balance to complete up to 6 months of treatment (inclusive of initial and dose modification treatment), if dose modification is being accessed following initial treatment.</p> <p align=""justify"">An application for continuing treatment must occur following an assessment of response conducted up to a maximum of 6 months from initiation of therapy. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment 6 months after initiating treatment with this drug for this condition (inclusive of initial and dose modification treatment), they will no longer be eligible to receive PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">An adequate clinical response under this treatment phase is defined as an average of at least 1 grade improvement in pruritus score on the Prucision<sup>TM</sup> ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.</p> <p align=""justify"">Confirmation of eligibility for dose modification treatment must be documented in the patient&apos;s medical records (include assessment of response score after at least 1 month and up to 3 months after commencing initial treatment).</p> <p align=""justify"">Any further authority applications occurring immediately after access through this dose modification listing are not to occur through the initial treatment listing.</p> <p align=""justify""><b>Dose modification</b></p><p align=""justify"">Where the drug&apos;s Product Information indicates variable dosing regimens based on the individual&apos;s response/tolerance, apply under this listing to continue treatment with the new strength. Mark any remaining repeat prescriptions for the discontinued strength with the word &apos;cancelled&apos;. This treatment phase listing recognises that a patient&apos;s optimal dose may not always be immediately apparent at the time of treatment initiation and therefore does not require confirmation of an objective, adequate response to the preceding supply of drug.</p> <p align=""justify"">Eligible patients must not be recommencing treatment directly through this treatment phase.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17704_17705_R","Continuing treatment (PFIC diagnosed prior to turning 18 years of age)","AUTHORITY_REQUIRED","17705","17704","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive familial intrahepatic cholestasis (PFIC)</p><br/><p>Continuing treatment (PFIC diagnosed prior to turning 18 years of age)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate clinical response to the most recent course of treatment; or</p> <p>Patient must be undergoing dose escalation to 120 micrograms/kg/day if they were unable to maintain a previously demonstrated adequate clinical response at 40 micrograms/kg/day in continuing treatment; AND</p> <p>Patient must not be undergoing treatment with this drug for this condition, where an adequate clinical response was unable to be maintained at 120 micrograms/kg/day; AND</p> <p>Must be treated by a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC), who is either a: (i) gastroenterologist, (ii) hepatologist; or</p> <p>Must be treated by a medical practitioner under the supervision of a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC).</p> <p align=""justify"">An adequate clinical response under this treatment phase is defined as an average of at least 1 grade improvement in pruritus score on the Prucision<sup>TM</sup> ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.</p> <p align=""justify"">Confirmation of eligibility for continuing treatment must be provided with the authority application and documented in the patient&apos;s medical records (include assessment of adequate clinical response to preceding supply).</p> <p align=""justify"">A patient may be eligible for treatment at the higher dose (120 micrograms/kg/day), if a loss of response occurred, or if an adequate response was unable to be maintained at the lower dose (40 micrograms/kg/day) during continuing treatment. To be eligible for continuing treatment at the higher dose (120 micrograms/kg/day), the patient must demonstrate and maintain an adequate clinical response at the higher dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive familial intrahepatic cholestasis (PFIC)</p><br/><p>Continuing treatment (PFIC diagnosed prior to turning 18 years of age)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate clinical response to the most recent course of treatment; or</p> <p>Patient must be undergoing dose escalation to 120 micrograms/kg/day if they were unable to maintain a previously demonstrated adequate clinical response at 40 micrograms/kg/day in continuing treatment; AND</p> <p>Patient must not be undergoing treatment with this drug for this condition, where an adequate clinical response was unable to be maintained at 120 micrograms/kg/day; AND</p> <p>Must be treated by a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC), who is either a: (i) gastroenterologist, (ii) hepatologist; or</p> <p>Must be treated by a medical practitioner under the supervision of a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC).</p> <p align=""justify"">An adequate clinical response under this treatment phase is defined as an average of at least 1 grade improvement in pruritus score on the Prucision<sup>TM</sup> ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.</p> <p align=""justify"">Confirmation of eligibility for continuing treatment must be provided with the authority application and documented in the patient&apos;s medical records (include assessment of adequate clinical response to preceding supply).</p> <p align=""justify"">A patient may be eligible for treatment at the higher dose (120 micrograms/kg/day), if a loss of response occurred, or if an adequate response was unable to be maintained at the lower dose (40 micrograms/kg/day) during continuing treatment. To be eligible for continuing treatment at the higher dose (120 micrograms/kg/day), the patient must demonstrate and maintain an adequate clinical response at the higher dose.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17708_17707_R","Continuing treatment","STREAMLINED","17707","17708","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17711_17714_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)","AUTHORITY_REQUIRED","17714","17711","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17712_N","null","null","null","null","null","<p align=""justify"">Cessation of therapy should be considered after the patient has demonstrated clinical benefit with omalizumab to re-evaluate the need for continued therapy. Any patient who ceases therapy and whose CSU relapses will need to re-initiate PBS-subsidised omalizumab as a new patient.</p>","Y","N","N","null","null","N","2017-09-01","N","4708"
"17713_17713_R","Continuing treatment","STREAMLINED","17713","17713","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17715_17715_R","Initial treatment","AUTHORITY_REQUIRED","17715","17715","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Enthesitis/spondylitis related juvenile idiopathic arthritis</p><br/><p>Initial treatment</p><br/><p>Patient must have a diagnosis of enthesitis/spondylitis related juvenile idiopathic arthritis defined by at least one of the following: (i) peripheral arthritis and enthesitis, (ii) inflammatory sacroiliitis on Magnetic Resonance Imaging (MRI) plus at least 3 months of inflammatory back pain, (iii) arthritis or enthesitis plus at least 2 of: (a) sacroiliac joint tenderness, (b) inflammatory back pain, (c) presence of HLA-B27 antigen, (d) acute (symptomatic) anterior uveitis, (e) history of spondyloarthritis in a first-degree relative; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have had a break in treatment of at least 2 years from the most recently prescribed PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response for axial disease (sacroiliitis and/or spondylitis), following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) whilst completing an appropriate exercise program, for a total period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response for peripheral disease (arthritis and/or enthesitis) following treatment with at least 2 NSAIDs, and either: (i) methotrexate at a dose of 15 mg per square metre (maximum 20 mg) weekly, (ii) sulfasalazine at a dose of 20 mg/kg (maximum 1 g) twice daily, whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""left"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p><p align=""left"">If treatment with methotrexate, sulfasalazine or NSAIDs is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p><p align=""left"">If intolerance to methotrexate, sulfasalazine or NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, details of the toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""left"">(a) a Juvenile Spondyloarthritis Disease Activity Index score greater than 2; or</p><p align=""left"">(b) persistent symptoms of axial spondylitis or sacroiliitis with prior confirmatory Magnetic Resonance Imaging (MRI) assessed by a clinician experienced with juvenile spondyloarthropathy.</p> <p align=""left"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(1) details of prior treatment including dose and duration of treatment; and</p><p align=""left"">(i) if applicable, the baseline Juvenile Spondyloarthritis Disease Activity Index score; or</p><p align=""left"">(ii) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) of the MRI demonstrating inflammatory spondylitis or sacroiliitis; or</p><p align=""left"">(iii) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) demonstrating the presence of HLA-B27.</p><p align=""left"">The Juvenile Spondyloarthritis Disease Activity Index score must be assessed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""left"">If a patient fails to demonstrate a response to treatment with this drug, they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition until 2 years have elapsed. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Enthesitis/spondylitis related juvenile idiopathic arthritis</p><br/><p>Initial treatment</p><br/><p>Patient must have a diagnosis of enthesitis/spondylitis related juvenile idiopathic arthritis defined by at least one of the following: (i) peripheral arthritis and enthesitis, (ii) inflammatory sacroiliitis on Magnetic Resonance Imaging (MRI) plus at least 3 months of inflammatory back pain, (iii) arthritis or enthesitis plus at least 2 of: (a) sacroiliac joint tenderness, (b) inflammatory back pain, (c) presence of HLA-B27 antigen, (d) acute (symptomatic) anterior uveitis, (e) history of spondyloarthritis in a first-degree relative; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have had a break in treatment of at least 2 years from the most recently prescribed PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response for axial disease (sacroiliitis and/or spondylitis), following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) whilst completing an appropriate exercise program, for a total period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response for peripheral disease (arthritis and/or enthesitis) following treatment with at least 2 NSAIDs, and either: (i) methotrexate at a dose of 15 mg per square metre (maximum 20 mg) weekly, (ii) sulfasalazine at a dose of 20 mg/kg (maximum 1 g) twice daily, whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""left"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p><p align=""left"">If treatment with methotrexate, sulfasalazine or NSAIDs is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p><p align=""left"">If intolerance to methotrexate, sulfasalazine or NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, details of the toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""left"">(a) a Juvenile Spondyloarthritis Disease Activity Index score greater than 2; or</p><p align=""left"">(b) persistent symptoms of axial spondylitis or sacroiliitis with prior confirmatory Magnetic Resonance Imaging (MRI) assessed by a clinician experienced with juvenile spondyloarthropathy.</p> <p align=""left"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(1) details of prior treatment including dose and duration of treatment; and</p><p align=""left"">(i) if applicable, the baseline Juvenile Spondyloarthritis Disease Activity Index score; or</p><p align=""left"">(ii) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) of the MRI demonstrating inflammatory spondylitis or sacroiliitis; or</p><p align=""left"">(iii) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) demonstrating the presence of HLA-B27.</p><p align=""left"">The Juvenile Spondyloarthritis Disease Activity Index score must be assessed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""left"">If a patient fails to demonstrate a response to treatment with this drug, they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition until 2 years have elapsed. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17716_17719_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","17719","17716","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""left"">(a) an active joint count of at least 10 active (swollen and tender) joints; or</p><p align=""left"">(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or</p><p align=""left"">(e) development/worsening of erosive disease due to active arthritis.</p><p align=""left"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p/><p align=""justify"">The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. </p><p/> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p align=""left"">At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""left"">(a) an active joint count of at least 10 active (swollen and tender) joints; or</p><p align=""left"">(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or</p><p align=""left"">(e) development/worsening of erosive disease due to active arthritis.</p><p align=""left"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p/><p align=""justify"">The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. </p><p/> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p align=""left"">At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p/><p align=""justify"">Use of alternative DMARDs in children is dependent on approval by the Therapeutic Goods Administration as age restrictions may apply. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17718_17717_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)","AUTHORITY_REQUIRED","17717","17718","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.</p><p align=""left"">All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient&apos;s medical records.</p> <p align=""left"">Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.</p> <p align=""left"">At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the date of the last continuing prescription.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.</p><p align=""left"">All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient&apos;s medical records.</p> <p align=""left"">Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.</p> <p align=""left"">At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the date of the last continuing prescription.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17720_17737_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)","AUTHORITY_REQUIRED","17737","17720","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17723_17724_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","17724","17723","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""left"">(a) an active joint count of at least 10 active (swollen and tender) joints; or</p><p align=""left"">(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or</p><p align=""left"">(e) development/worsening of erosive disease due to active arthritis.</p><p align=""left"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p/><p align=""justify"">The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. </p><p/> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p>At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""left"">(a) an active joint count of at least 10 active (swollen and tender) joints; or</p><p align=""left"">(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or</p><p align=""left"">(e) development/worsening of erosive disease due to active arthritis.</p><p align=""left"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p/><p align=""justify"">The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. </p><p/> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p>At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p/><p align=""justify"">Use of alternative DMARDs in children is dependent on approval by the Therapeutic Goods Administration as age restrictions may apply. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17726_17742_R","Continuing treatment","STREAMLINED","17742","17726","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must be 30kg or over; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must be 30kg or over; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17727_17710_R","Continuing treatment","STREAMLINED","17710","17727","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must be under 30kg; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must be under 30kg; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17728_17712_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","17712","17728","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""left"">(a) an active joint count of at least 10 active (swollen and tender) joints; or</p><p align=""left"">(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or</p><p align=""left"">(e) development/worsening of erosive disease due to active arthritis.</p><p align=""left"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p/><p align=""justify"">The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. </p><p/> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""left"">(a) an active joint count of at least 10 active (swollen and tender) joints; or</p><p align=""left"">(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or</p><p align=""left"">(e) development/worsening of erosive disease due to active arthritis.</p><p align=""left"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p/><p align=""justify"">The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. </p><p/> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p/><p align=""justify"">Use of alternative DMARDs in children is dependent on approval by the Therapeutic Goods Administration as age restrictions may apply. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17730_17730_R","Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements","AUTHORITY_REQUIRED","17730","17730","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Enthesitis/spondylitis related juvenile idiopathic arthritis</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 January 2026; AND</p> <p>Patient must have, prior to initiating treatment with this drug for this condition, a diagnosis of enthesitis/spondylitis related juvenile idiopathic arthritis defined by at least one of the following: (i) peripheral arthritis and enthesitis, (ii) inflammatory sacroiliitis on Magnetic Resonance Imaging (MRI) plus at least 3 months of inflammatory back pain, (iii) arthritis or enthesitis plus at least 2 of: (a) sacroiliac joint tenderness, (b) inflammatory back pain, (c) presence of HLA-B27 antigen, (d) acute (symptomatic) anterior uveitis, (e) history of spondyloarthritis in a first-degree relative; AND</p> <p>Patient must have, prior to initiating treatment with this drug for this condition, failed to achieve an adequate response for axial disease (sacroiliitis and/or spondylitis), following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) whilst completing an appropriate exercise program, for a total period of 3 months; or</p> <p>Patient must have, prior to initiating treatment with this drug for this condition, failed to achieve an adequate response for peripheral disease (arthritis and/or enthesitis) following treatment with at least 2 NSAIDs, and either: (i) methotrexate at a dose of 15 mg per square metre (maximum 20 mg) weekly, (ii) sulfasalazine at a dose of 20 mg/kg (maximum 1 g) twice daily, whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a paediatric rheumatologist; or</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must be under 18 years of age, prior to commencement of this drug for this condition.</p> <p align=""left"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p><p align=""left"">If treatment with methotrexate, sulfasalazine or NSAIDs is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p><p align=""left"">If intolerance to methotrexate, sulfasalazine or NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, details of the toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""left"">(a) a Juvenile Spondyloarthritis Disease Activity Index score greater than 2; or</p><p align=""left"">(b) persistent symptoms of axial spondylitis or sacroiliitis with prior confirmatory Magnetic Resonance Imaging (MRI) assessed by a clinician experienced with juvenile spondyloarthropathy.</p> <p align=""left"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(1) details of prior treatment including dose and duration of treatment; and</p><p align=""left"">(i) if applicable, a baseline Juvenile Spondyloarthritis Disease Activity Index score; or</p><p align=""left"">(ii) if applicable, the current Juvenile Spondyloarthritis Disease Activity Index score; or</p><p align=""left"">(iii) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) of the MRI demonstrating inflammatory spondylitis or sacroiliitis; or</p><p align=""left"">(iv) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) demonstrating the presence of HLA-B27.</p><p align=""left"">The Juvenile Spondyloarthritis Disease Activity Index score must be assessed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p> <p align=""left"">An adequate response is defined as an improvement from baseline in the Juvenile Spondyloarthritis Disease Activity Index score by at least 30% or an improvement in the persistent symptoms of axial spondylitis or sacroiliitis.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""left"">If a patient fails to demonstrate a response to treatment with this drug, they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition until 2 years have elapsed. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Enthesitis/spondylitis related juvenile idiopathic arthritis</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 January 2026; AND</p> <p>Patient must have, prior to initiating treatment with this drug for this condition, a diagnosis of enthesitis/spondylitis related juvenile idiopathic arthritis defined by at least one of the following: (i) peripheral arthritis and enthesitis, (ii) inflammatory sacroiliitis on Magnetic Resonance Imaging (MRI) plus at least 3 months of inflammatory back pain, (iii) arthritis or enthesitis plus at least 2 of: (a) sacroiliac joint tenderness, (b) inflammatory back pain, (c) presence of HLA-B27 antigen, (d) acute (symptomatic) anterior uveitis, (e) history of spondyloarthritis in a first-degree relative; AND</p> <p>Patient must have, prior to initiating treatment with this drug for this condition, failed to achieve an adequate response for axial disease (sacroiliitis and/or spondylitis), following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) whilst completing an appropriate exercise program, for a total period of 3 months; or</p> <p>Patient must have, prior to initiating treatment with this drug for this condition, failed to achieve an adequate response for peripheral disease (arthritis and/or enthesitis) following treatment with at least 2 NSAIDs, and either: (i) methotrexate at a dose of 15 mg per square metre (maximum 20 mg) weekly, (ii) sulfasalazine at a dose of 20 mg/kg (maximum 1 g) twice daily, whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a paediatric rheumatologist; or</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must be under 18 years of age, prior to commencement of this drug for this condition.</p> <p align=""left"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p><p align=""left"">If treatment with methotrexate, sulfasalazine or NSAIDs is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p><p align=""left"">If intolerance to methotrexate, sulfasalazine or NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, details of the toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""left"">(a) a Juvenile Spondyloarthritis Disease Activity Index score greater than 2; or</p><p align=""left"">(b) persistent symptoms of axial spondylitis or sacroiliitis with prior confirmatory Magnetic Resonance Imaging (MRI) assessed by a clinician experienced with juvenile spondyloarthropathy.</p> <p align=""left"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(1) details of prior treatment including dose and duration of treatment; and</p><p align=""left"">(i) if applicable, a baseline Juvenile Spondyloarthritis Disease Activity Index score; or</p><p align=""left"">(ii) if applicable, the current Juvenile Spondyloarthritis Disease Activity Index score; or</p><p align=""left"">(iii) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) of the MRI demonstrating inflammatory spondylitis or sacroiliitis; or</p><p align=""left"">(iv) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) demonstrating the presence of HLA-B27.</p><p align=""left"">The Juvenile Spondyloarthritis Disease Activity Index score must be assessed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p> <p align=""left"">An adequate response is defined as an improvement from baseline in the Juvenile Spondyloarthritis Disease Activity Index score by at least 30% or an improvement in the persistent symptoms of axial spondylitis or sacroiliitis.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""left"">If a patient fails to demonstrate a response to treatment with this drug, they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition until 2 years have elapsed. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17731_17731_R","Initial treatment - balance of supply","AUTHORITY_REQUIRED","17731","17731","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Enthesitis/spondylitis related juvenile idiopathic arthritis</p><br/><p>Initial treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Enthesitis/spondylitis related juvenile idiopathic arthritis</p><br/><p>Initial treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17732_17733_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)","AUTHORITY_REQUIRED","17733","17732","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""left"">At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""left"">At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17734_17734_R","Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements","AUTHORITY_REQUIRED","17734","17734","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 January 2026; AND</p> <p>Patient must have, prior to initiating treatment with this drug for this condition, demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have, prior to initiating treatment with this drug for this condition, demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must be under 18 years of age, prior to commencement of this drug for this condition.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""left"">(a) an active joint count of at least 10 active (swollen and tender) joints; or</p><p align=""left"">(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or</p><p align=""left"">(e) development/worsening of erosive disease due to active arthritis.</p><p align=""left"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p/><p align=""justify"">The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. </p><p/> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 January 2026; AND</p> <p>Patient must have, prior to initiating treatment with this drug for this condition, demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have, prior to initiating treatment with this drug for this condition, demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must be under 18 years of age, prior to commencement of this drug for this condition.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""left"">(a) an active joint count of at least 10 active (swollen and tender) joints; or</p><p align=""left"">(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or</p><p align=""left"">(e) development/worsening of erosive disease due to active arthritis.</p><p align=""left"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p/><p align=""justify"">The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. </p><p/> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p/><p align=""justify"">Use of alternative DMARDs in children is dependent on approval by the Therapeutic Goods Administration as age restrictions may apply. </p><p/> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17736_17736_R","Continuing treatment","STREAMLINED","17736","17736","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Enthesitis/spondylitis related juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a paediatric rheumatologist; or</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""left"">An adequate response is defined as an improvement from baseline in the Juvenile Spondyloarthritis Disease Activity Index score by at least 30% or an improvement in the persistent symptoms of axial spondylitis or sacroiliitis.</p> <p align=""left"">If a patient fails to demonstrate a response to treatment with this drug, they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition until 2 years have elapsed. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 2 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed, and the date of the first application submitted for approval.</p> <p align=""left"">Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient&apos;s response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Enthesitis/spondylitis related juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a paediatric rheumatologist; or</p> <p>Must be treated by a rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.</p> <p align=""left"">An adequate response is defined as an improvement from baseline in the Juvenile Spondyloarthritis Disease Activity Index score by at least 30% or an improvement in the persistent symptoms of axial spondylitis or sacroiliitis.</p> <p align=""left"">If a patient fails to demonstrate a response to treatment with this drug, they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition until 2 years have elapsed. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 2 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed, and the date of the first application submitted for approval.</p> <p align=""left"">Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient&apos;s response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17739_17721_R","Continuing treatment (PFIC diagnosed after turning 18 years of age)","AUTHORITY_REQUIRED","17721","17739","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive familial intrahepatic cholestasis (PFIC)</p><br/><p>Continuing treatment (PFIC diagnosed after turning 18 years of age)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate clinical response to the most recent course of treatment; or</p> <p>Patient must be undergoing dose escalation to 120 micrograms/kg/day if they were unable to maintain a previously demonstrated adequate clinical response at 40 micrograms/kg/day in continuing treatment; AND</p> <p>Patient must not be undergoing treatment with this drug for this condition, where an adequate clinical response was unable to be maintained at 120 micrograms/kg/day; AND</p> <p>Must be treated by a specialist hepatologist experienced in the management of progressive familial intrahepatic cholestasis (PFIC); or</p> <p>Must be treated by a medical practitioner under the supervision of a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC).</p> <p align=""justify"">An adequate clinical response under this treatment phase is defined as an average of at least 1 grade improvement in pruritus score on the Prucision<sup>TM</sup> ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.</p> <p align=""justify"">Confirmation of eligibility for continuing treatment must be provided with the authority application and documented in the patient&apos;s medical records (include assessment of adequate clinical response to preceding supply).</p> <p align=""justify"">A patient may be eligible for treatment at the higher dose (120 micrograms/kg/day), if a loss of response occurred, or if an adequate response was unable to be maintained at the lower dose (40 micrograms/kg/day) during continuing treatment. To be eligible for continuing treatment at the higher dose (120 micrograms/kg/day), the patient must demonstrate and maintain an adequate clinical response at the higher dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive familial intrahepatic cholestasis (PFIC)</p><br/><p>Continuing treatment (PFIC diagnosed after turning 18 years of age)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate clinical response to the most recent course of treatment; or</p> <p>Patient must be undergoing dose escalation to 120 micrograms/kg/day if they were unable to maintain a previously demonstrated adequate clinical response at 40 micrograms/kg/day in continuing treatment; AND</p> <p>Patient must not be undergoing treatment with this drug for this condition, where an adequate clinical response was unable to be maintained at 120 micrograms/kg/day; AND</p> <p>Must be treated by a specialist hepatologist experienced in the management of progressive familial intrahepatic cholestasis (PFIC); or</p> <p>Must be treated by a medical practitioner under the supervision of a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC).</p> <p align=""justify"">An adequate clinical response under this treatment phase is defined as an average of at least 1 grade improvement in pruritus score on the Prucision<sup>TM</sup> ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.</p> <p align=""justify"">Confirmation of eligibility for continuing treatment must be provided with the authority application and documented in the patient&apos;s medical records (include assessment of adequate clinical response to preceding supply).</p> <p align=""justify"">A patient may be eligible for treatment at the higher dose (120 micrograms/kg/day), if a loss of response occurred, or if an adequate response was unable to be maintained at the lower dose (40 micrograms/kg/day) during continuing treatment. To be eligible for continuing treatment at the higher dose (120 micrograms/kg/day), the patient must demonstrate and maintain an adequate clinical response at the higher dose.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17740_17703_R","Initial treatment (PFIC diagnosed after turning 18 years of age)","AUTHORITY_REQUIRED","17703","17740","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive familial intrahepatic cholestasis (PFIC)</p><br/><p>Initial treatment (PFIC diagnosed after turning 18 years of age)</p><br/><p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Patient must have a clinical diagnosis of progressive familial intrahepatic cholestasis (PFIC); AND</p> <p>Patient must have elevated serum bile acids at treatment initiation with this drug; AND</p> <p>Patient must be experiencing itch at treatment initiation with this drug, with other factors causing pruritus excluded through both: (i) physical examination, (ii) patient history; AND</p> <p>Patient must have had an average pruritus score of at least 2 on the PrucisionTM ObsRO Pruritus Scale assessed on three occasions over a one-week period prior to treatment initiation with this drug; AND</p> <p>Must be treated by a specialist hepatologist experienced in the management of progressive familial intrahepatic cholestasis (PFIC); AND</p> <p>Patient must be/have been diagnosed after turning 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pruritus score using the Prucision<sup>TM</sup> ObsRO Pruritus scale;</p><p align=""justify"">(2) details of serum bile acids (date and micromol/L).</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescriber must exclude any other causes of pruritus which include any of the following:</p><p align=""justify"">(i) drug related (e.g., opioid-related pruritus);</p><p align=""justify"">(ii) drug hypersensitivity or adverse effect; contact dermatitis; allergy;</p><p align=""justify"">(iii) differential diagnoses (e.g., xerosis; infestations; iron deficiency; chronic kidney disease; polycythaemia vera/leukaemia/lymphoma; hypothyroidism; uncontrolled diabetes, eczema, scabies).</p> <p align=""justify"">At the time of the authority application, the prescriber should request the appropriate strength(s) and quantity based on the patient&apos;s weight, according to the dosing schedule in the TGA-approved Product Information to provide sufficient drug for one month&apos;s supply with 2 repeats. A separate authority approval is required for each strength requested.</p> <p align=""justify"">An application for continuing treatment must occur following an assessment of response conducted up to 3 months of therapy. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">An application for dose modification treatment must occur following an assessment of response conducted from 1 month of therapy up to 3 months of therapy. This will enable ongoing treatment for those who meet the dose modification restriction criteria for PBS-subsidised treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug after 1 month, they will be eligible to receive PBS-subsidised treatment at a higher dose with this drug for this condition under the dose modification treatment phase for a maximum of 5 months; annotate any remaining repeat prescriptions with the word &apos;cancelled&apos; where this occurs within this treatment phase.</p> <p align=""justify"">All diagnostic reports/tools must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An adequate clinical response to initial treatment is defined as an average of at least 1 grade improvement in pruritus score on the Prucision<sup>TM</sup> ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.</p> <p align=""justify"">Eligible patients must not be recommencing treatment directly through this treatment phase.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive familial intrahepatic cholestasis (PFIC)</p><br/><p>Initial treatment (PFIC diagnosed after turning 18 years of age)</p><br/><p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Patient must have a clinical diagnosis of progressive familial intrahepatic cholestasis (PFIC); AND</p> <p>Patient must have elevated serum bile acids at treatment initiation with this drug; AND</p> <p>Patient must be experiencing itch at treatment initiation with this drug, with other factors causing pruritus excluded through both: (i) physical examination, (ii) patient history; AND</p> <p>Patient must have had an average pruritus score of at least 2 on the PrucisionTM ObsRO Pruritus Scale assessed on three occasions over a one-week period prior to treatment initiation with this drug; AND</p> <p>Must be treated by a specialist hepatologist experienced in the management of progressive familial intrahepatic cholestasis (PFIC); AND</p> <p>Patient must be/have been diagnosed after turning 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pruritus score using the Prucision<sup>TM</sup> ObsRO Pruritus scale;</p><p align=""justify"">(2) details of serum bile acids (date and micromol/L).</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescriber must exclude any other causes of pruritus which include any of the following:</p><p align=""justify"">(i) drug related (e.g., opioid-related pruritus);</p><p align=""justify"">(ii) drug hypersensitivity or adverse effect; contact dermatitis; allergy;</p><p align=""justify"">(iii) differential diagnoses (e.g., xerosis; infestations; iron deficiency; chronic kidney disease; polycythaemia vera/leukaemia/lymphoma; hypothyroidism; uncontrolled diabetes, eczema, scabies).</p> <p align=""justify"">At the time of the authority application, the prescriber should request the appropriate strength(s) and quantity based on the patient&apos;s weight, according to the dosing schedule in the TGA-approved Product Information to provide sufficient drug for one month&apos;s supply with 2 repeats. A separate authority approval is required for each strength requested.</p> <p align=""justify"">An application for continuing treatment must occur following an assessment of response conducted up to 3 months of therapy. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">An application for dose modification treatment must occur following an assessment of response conducted from 1 month of therapy up to 3 months of therapy. This will enable ongoing treatment for those who meet the dose modification restriction criteria for PBS-subsidised treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug after 1 month, they will be eligible to receive PBS-subsidised treatment at a higher dose with this drug for this condition under the dose modification treatment phase for a maximum of 5 months; annotate any remaining repeat prescriptions with the word &apos;cancelled&apos; where this occurs within this treatment phase.</p> <p align=""justify"">All diagnostic reports/tools must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An adequate clinical response to initial treatment is defined as an average of at least 1 grade improvement in pruritus score on the Prucision<sup>TM</sup> ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.</p> <p align=""justify"">Eligible patients must not be recommencing treatment directly through this treatment phase.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","Y","4708"
"17741_17725_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)","AUTHORITY_REQUIRED","17725","17741","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p>At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p>At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17743_17709_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)","AUTHORITY_REQUIRED","17709","17743","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis.</p> <p align=""left"">Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.</p><p align=""left"">All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient&apos;s medical records.</p> <p align=""left"">Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.</p> <p align=""justify"">Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the date of the last continuing prescription.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis.</p> <p align=""left"">Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.</p><p align=""left"">All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient&apos;s medical records.</p> <p align=""left"">Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.</p> <p align=""justify"">Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the date of the last continuing prescription.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17744_17745_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","17745","17744","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""left"">(a) an active joint count of at least 10 active (swollen and tender) joints; or</p><p align=""left"">(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or</p><p align=""left"">(e) development/worsening of erosive disease due to active arthritis.</p><p align=""left"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p/><p align=""justify"">The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. </p><p/> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""left"">(a) an active joint count of at least 10 active (swollen and tender) joints; or</p><p align=""left"">(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or</p><p align=""left"">(e) development/worsening of erosive disease due to active arthritis.</p><p align=""left"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p/><p align=""justify"">The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. </p><p/> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p/><p align=""justify"">Use of alternative DMARDs in children is dependent on approval by the Therapeutic Goods Administration as age restrictions may apply. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17747_17701_R","Initial treatment (PFIC diagnosed prior to turning 18 years of age)","AUTHORITY_REQUIRED","17701","17747","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive familial intrahepatic cholestasis (PFIC)</p><br/><p>Initial treatment (PFIC diagnosed prior to turning 18 years of age)</p><br/><p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Patient must have a clinical diagnosis of progressive familial intrahepatic cholestasis (PFIC); AND</p> <p>Patient must have elevated serum bile acids at treatment initiation with this drug; AND</p> <p>Patient must be experiencing itch at treatment initiation with this drug, with other factors causing pruritus excluded through both: (i) physical examination, (ii) patient history; AND</p> <p>Patient must have had an average pruritus score of at least 2 on the PrucisionTM ObsRO Pruritus Scale assessed on three occasions over a one-week period prior to treatment initiation with this drug; AND</p> <p>Must be treated by a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC), who is either a: (i) gastroenterologist, (ii) hepatologist; AND</p> <p>Patient must be aged between 6 months and 17 years inclusive; or</p> <p>Patient must be/have been diagnosed prior to turning 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pruritus score using the Prucision<sup>TM</sup> ObsRO Pruritus scale;</p><p align=""justify"">(2) details of serum bile acids (date and micromol/L).</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescriber must exclude any other causes of pruritus which include any of the following:</p><p align=""justify"">(i) drug related (e.g., opioid-related pruritus);</p><p align=""justify"">(ii) drug hypersensitivity or adverse effect; contact dermatitis; allergy;</p><p align=""justify"">(iii) differential diagnoses (e.g., xerosis; infestations; iron deficiency; chronic kidney disease; polycythaemia vera/leukaemia/lymphoma; hypothyroidism; uncontrolled diabetes, eczema, scabies).</p> <p align=""justify"">At the time of the authority application, the prescriber should request the appropriate strength(s) and quantity based on the patient&apos;s weight, according to the dosing schedule in the TGA-approved Product Information to provide sufficient drug for one month&apos;s supply with 2 repeats. A separate authority approval is required for each strength requested.</p> <p align=""justify"">An application for continuing treatment must occur following an assessment of response conducted up to 3 months of therapy. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">An application for dose modification treatment must occur following an assessment of response conducted from 1 month of therapy up to 3 months of therapy. This will enable ongoing treatment for those who meet the dose modification restriction criteria for PBS-subsidised treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug after 1 month, they will be eligible to receive PBS-subsidised treatment at a higher dose with this drug for this condition under the dose modification treatment phase for a maximum of 5 months; annotate any remaining repeat prescriptions with the word &apos;cancelled&apos; where this occurs within this treatment phase.</p> <p align=""justify"">All diagnostic reports/tools must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An adequate clinical response to initial treatment is defined as an average of at least 1 grade improvement in pruritus score on the Prucision<sup>TM</sup> ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.</p> <p align=""justify"">Eligible patients must not be recommencing treatment directly through this treatment phase.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive familial intrahepatic cholestasis (PFIC)</p><br/><p>Initial treatment (PFIC diagnosed prior to turning 18 years of age)</p><br/><p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND</p> <p>Patient must have a clinical diagnosis of progressive familial intrahepatic cholestasis (PFIC); AND</p> <p>Patient must have elevated serum bile acids at treatment initiation with this drug; AND</p> <p>Patient must be experiencing itch at treatment initiation with this drug, with other factors causing pruritus excluded through both: (i) physical examination, (ii) patient history; AND</p> <p>Patient must have had an average pruritus score of at least 2 on the PrucisionTM ObsRO Pruritus Scale assessed on three occasions over a one-week period prior to treatment initiation with this drug; AND</p> <p>Must be treated by a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC), who is either a: (i) gastroenterologist, (ii) hepatologist; AND</p> <p>Patient must be aged between 6 months and 17 years inclusive; or</p> <p>Patient must be/have been diagnosed prior to turning 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pruritus score using the Prucision<sup>TM</sup> ObsRO Pruritus scale;</p><p align=""justify"">(2) details of serum bile acids (date and micromol/L).</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescriber must exclude any other causes of pruritus which include any of the following:</p><p align=""justify"">(i) drug related (e.g., opioid-related pruritus);</p><p align=""justify"">(ii) drug hypersensitivity or adverse effect; contact dermatitis; allergy;</p><p align=""justify"">(iii) differential diagnoses (e.g., xerosis; infestations; iron deficiency; chronic kidney disease; polycythaemia vera/leukaemia/lymphoma; hypothyroidism; uncontrolled diabetes, eczema, scabies).</p> <p align=""justify"">At the time of the authority application, the prescriber should request the appropriate strength(s) and quantity based on the patient&apos;s weight, according to the dosing schedule in the TGA-approved Product Information to provide sufficient drug for one month&apos;s supply with 2 repeats. A separate authority approval is required for each strength requested.</p> <p align=""justify"">An application for continuing treatment must occur following an assessment of response conducted up to 3 months of therapy. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">An application for dose modification treatment must occur following an assessment of response conducted from 1 month of therapy up to 3 months of therapy. This will enable ongoing treatment for those who meet the dose modification restriction criteria for PBS-subsidised treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug after 1 month, they will be eligible to receive PBS-subsidised treatment at a higher dose with this drug for this condition under the dose modification treatment phase for a maximum of 5 months; annotate any remaining repeat prescriptions with the word &apos;cancelled&apos; where this occurs within this treatment phase.</p> <p align=""justify"">All diagnostic reports/tools must be documented in the patient&apos;s medical records.</p> <p align=""justify"">An adequate clinical response to initial treatment is defined as an average of at least 1 grade improvement in pruritus score on the Prucision<sup>TM</sup> ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.</p> <p align=""justify"">Eligible patients must not be recommencing treatment directly through this treatment phase.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","Y","4708"
"17749_17746_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)","AUTHORITY_REQUIRED","17746","17749","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.</p><p align=""left"">All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient&apos;s medical records.</p> <p align=""left"">Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the date of the last continuing prescription.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.</p><p align=""left"">All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient&apos;s medical records.</p> <p align=""left"">Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the date of the last continuing prescription.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17750_17738_R","Dose modification (Dose escalation from initial treatment phase; for PFIC diagnosed prior to turning 18 years of age)","AUTHORITY_REQUIRED","17738","17750","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive familial intrahepatic cholestasis (PFIC)</p><br/><p>Dose modification (Dose escalation from initial treatment phase; for PFIC diagnosed prior to turning 18 years of age)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have demonstrated an adequate clinical response after at least 1 month and up to 3 months following commencement of treatment at 40 micrograms/kg/day; AND</p> <p>Patient must be undergoing treatment with this drug for this condition at 120 micrograms/kg/day; AND</p> <p>Must be treated by a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC), who is either a: (i) gastroenterologist, (ii) hepatologist; or</p> <p>Must be treated by a medical practitioner under the supervision of a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC).</p> <p align=""justify"">At the time of the authority application, the prescriber should request sufficient quantity and repeats to provide for the balance to complete up to 6 months of treatment (inclusive of initial and dose modification treatment), if dose modification is being accessed following initial treatment.</p> <p align=""justify"">An application for continuing treatment must occur following an assessment of response conducted up to a maximum of 6 months from initiation of therapy. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment 6 months after initiating treatment with this drug for this condition (inclusive of initial and dose modification treatment), they will no longer be eligible to receive PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">An adequate clinical response under this treatment phase is defined as an average of at least 1 grade improvement in pruritus score on the Prucision<sup>TM</sup> ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.</p> <p align=""justify"">Confirmation of eligibility for dose modification treatment must be documented in the patient&apos;s medical records (include assessment of response score after at least 1 month and up to 3 months after commencing initial treatment).</p> <p align=""justify"">Any further authority applications occurring immediately after access through this dose modification listing are not to occur through the initial treatment listing.</p> <p align=""justify""><b>Dose modification</b></p><p align=""justify"">Where the drug&apos;s Product Information indicates variable dosing regimens based on the individual&apos;s response/tolerance, apply under this listing to continue treatment with the new strength. Mark any remaining repeat prescriptions for the discontinued strength with the word &apos;cancelled&apos;. This treatment phase listing recognises that a patient&apos;s optimal dose may not always be immediately apparent at the time of treatment initiation and therefore does not require confirmation of an objective, adequate response to the preceding supply of drug.</p> <p align=""justify"">Eligible patients must not be recommencing treatment directly through this treatment phase.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Progressive familial intrahepatic cholestasis (PFIC)</p><br/><p>Dose modification (Dose escalation from initial treatment phase; for PFIC diagnosed prior to turning 18 years of age)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have demonstrated an adequate clinical response after at least 1 month and up to 3 months following commencement of treatment at 40 micrograms/kg/day; AND</p> <p>Patient must be undergoing treatment with this drug for this condition at 120 micrograms/kg/day; AND</p> <p>Must be treated by a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC), who is either a: (i) gastroenterologist, (ii) hepatologist; or</p> <p>Must be treated by a medical practitioner under the supervision of a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC).</p> <p align=""justify"">At the time of the authority application, the prescriber should request sufficient quantity and repeats to provide for the balance to complete up to 6 months of treatment (inclusive of initial and dose modification treatment), if dose modification is being accessed following initial treatment.</p> <p align=""justify"">An application for continuing treatment must occur following an assessment of response conducted up to a maximum of 6 months from initiation of therapy. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment 6 months after initiating treatment with this drug for this condition (inclusive of initial and dose modification treatment), they will no longer be eligible to receive PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">An adequate clinical response under this treatment phase is defined as an average of at least 1 grade improvement in pruritus score on the Prucision<sup>TM</sup> ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.</p> <p align=""justify"">Confirmation of eligibility for dose modification treatment must be documented in the patient&apos;s medical records (include assessment of response score after at least 1 month and up to 3 months after commencing initial treatment).</p> <p align=""justify"">Any further authority applications occurring immediately after access through this dose modification listing are not to occur through the initial treatment listing.</p> <p align=""justify""><b>Dose modification</b></p><p align=""justify"">Where the drug&apos;s Product Information indicates variable dosing regimens based on the individual&apos;s response/tolerance, apply under this listing to continue treatment with the new strength. Mark any remaining repeat prescriptions for the discontinued strength with the word &apos;cancelled&apos;. This treatment phase listing recognises that a patient&apos;s optimal dose may not always be immediately apparent at the time of treatment initiation and therefore does not require confirmation of an objective, adequate response to the preceding supply of drug.</p> <p align=""justify"">Eligible patients must not be recommencing treatment directly through this treatment phase.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17751_17706_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)","AUTHORITY_REQUIRED","17706","17751","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.</p><p align=""left"">All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient&apos;s medical records.</p> <p align=""left"">Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.</p> <p>At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the date of the last continuing prescription.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.</p><p align=""left"">All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient&apos;s medical records.</p> <p align=""left"">Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.</p> <p>At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the date of the last continuing prescription.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17752_17729_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)","AUTHORITY_REQUIRED","17729","17752","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.</p><p align=""left"">All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient&apos;s medical records.</p> <p align=""left"">Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the date of the last continuing prescription.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""left"">Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.</p><p align=""left"">All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient&apos;s medical records.</p> <p align=""left"">Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) the date of the last continuing prescription.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17754_17757_R","null","AUTHORITY_REQUIRED","17757","17754","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage III or IV CD30 positive Hodgkin lymphoma</p><br/><p>The treatment must be for first line therapy for this condition; AND</p> <p>The treatment must be for curative intent; AND</p> <p>The treatment must be in combination with at least the following: (i) doxorubicin, (ii) vinblastine; AND</p> <p>The treatment must not be in combination with (i) etoposide, (ii) cyclophosphamide; AND</p> <p>The treatment must not be more than 6 treatment cycles under this restriction in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage III or IV CD30 positive Hodgkin lymphoma</p><br/><p>The treatment must be for first line therapy for this condition; AND</p> <p>The treatment must be for curative intent; AND</p> <p>The treatment must be in combination with at least the following: (i) doxorubicin, (ii) vinblastine; AND</p> <p>The treatment must not be in combination with (i) etoposide, (ii) cyclophosphamide; AND</p> <p>The treatment must not be more than 6 treatment cycles under this restriction in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17755_17760_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","17760","17755","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND</p> <p>Patient must be under 18 years of age.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""left"">(a) an active joint count of at least 10 active (swollen and tender) joints; or</p><p align=""left"">(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or</p><p align=""left"">(e) development/worsening of erosive disease due to active arthritis.</p><p align=""left"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p/><p align=""justify"">The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. </p><p/> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or</p> <p>Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND</p> <p>Patient must be under 18 years of age.</p> <p/><p align=""justify"">Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. </p><p/> <p/><p align=""justify"">Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. </p><p/> <p align=""justify"">If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient&apos;s medical records.</p> <p align=""left"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""left"">(a) an active joint count of at least 10 active (swollen and tender) joints; or</p><p align=""left"">(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or</p><p align=""left"">(e) development/worsening of erosive disease due to active arthritis.</p><p align=""left"">The assessment of response to prior treatment must be documented in the patient&apos;s medical records.</p> <p/><p align=""justify"">The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. </p><p/> <p align=""justify"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the date of assessment of severe active juvenile idiopathic arthritis; and</p><p align=""justify"">(b) details of prior treatment including dose and duration of treatment.</p> <p align=""justify"">Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p/><p align=""justify"">Use of alternative DMARDs in children is dependent on approval by the Therapeutic Goods Administration as age restrictions may apply. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17758_17748_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)","AUTHORITY_REQUIRED","17748","17758","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle.</p> <p align=""left"">An adequate response to treatment is defined as:</p><p align=""left"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or</p><p align=""left"">(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or</p><p align=""left"">(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or</p><p align=""left"">(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or</p><p align=""left"">(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.</p><p align=""left"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">The assessment of the patient&apos;s response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17759_17753_R","Continuing treatment","AUTHORITY_REQUIRED","17753","17759","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High-risk neuroblastoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease recurrence while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 27 cycles (based on 4 weeks per cycle) from the first dose of this drug, regardless of whether it was PBS/non-PBS-subsidised; AND</p> <p>Must be treated in a hospital/cancer centre by either a: (i) paediatric oncologist, (ii) haematologist; or</p> <p>Must be treated by a medical practitioner under the direct supervision of either a: (i) paediatric oncologist, (ii) haematologist.</p> <p align=""justify"">At the time of the authority application, the prescriber should request an appropriate quantity and number of repeats based on the patient&apos;s Body Surface Area (BSA), according to the dosing schedule in the TGA approved Product Information.</p><p align=""justify"">The following maximum quantity units and repeats may be authorised under this restriction (providing 3 months of therapy for each prescription).</p><p align=""justify"">Up to a maximum quantity of 100 units and 1 repeat for a BSA 0.25 m<sup>2</sup> to less than 0.5 m<sup>2</sup>;</p><p align=""justify"">Up to a maximum quantity of 200 units and 1 repeat for a BSA 0.5 m<sup>2</sup> to less than 0.75 m<sup>2</sup>;</p><p align=""justify"">Up to a maximum quantity of 200 units and 2 repeats for a BSA 0.75 m<sup>2</sup> to 1.5 m<sup>2</sup>;</p><p align=""justify"">Up to a maximum quantity of 300 units and 2 repeats for a BSA greater than 1.5 m<sup>2</sup>.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High-risk neuroblastoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease recurrence while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 27 cycles (based on 4 weeks per cycle) from the first dose of this drug, regardless of whether it was PBS/non-PBS-subsidised; AND</p> <p>Must be treated in a hospital/cancer centre by either a: (i) paediatric oncologist, (ii) haematologist; or</p> <p>Must be treated by a medical practitioner under the direct supervision of either a: (i) paediatric oncologist, (ii) haematologist.</p> <p align=""justify"">At the time of the authority application, the prescriber should request an appropriate quantity and number of repeats based on the patient&apos;s Body Surface Area (BSA), according to the dosing schedule in the TGA approved Product Information.</p><p align=""justify"">The following maximum quantity units and repeats may be authorised under this restriction (providing 3 months of therapy for each prescription).</p><p align=""justify"">Up to a maximum quantity of 100 units and 1 repeat for a BSA 0.25 m<sup>2</sup> to less than 0.5 m<sup>2</sup>;</p><p align=""justify"">Up to a maximum quantity of 200 units and 1 repeat for a BSA 0.5 m<sup>2</sup> to less than 0.75 m<sup>2</sup>;</p><p align=""justify"">Up to a maximum quantity of 200 units and 2 repeats for a BSA 0.75 m<sup>2</sup> to 1.5 m<sup>2</sup>;</p><p align=""justify"">Up to a maximum quantity of 300 units and 2 repeats for a BSA greater than 1.5 m<sup>2</sup>.</p>","N","N","N","IMMEDIATE","ALL","N","2026-01-01","N","4708"
"17764_17763_R","Continuing treatment","AUTHORITY_REQUIRED","17763","17764","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be at least 1 year of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and</p><p align=""justify"">(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be at least 1 year of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and</p><p align=""justify"">(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17766_17934_R","Initial treatment","AUTHORITY_REQUIRED","17934","17766","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and</p><p align=""justify"">(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and</p><p align=""justify"">(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17767_17935_R","Continuing treatment","AUTHORITY_REQUIRED","17935","17767","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis - one residual function (RF) mutation</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.</p> <p align=""justify"">Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort;</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and</p><p align=""justify"">(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis - one residual function (RF) mutation</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.</p> <p align=""justify"">Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort;</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and</p><p align=""justify"">(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17768_17769_R","Continuing treatment","AUTHORITY_REQUIRED","17769","17768","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be at least 6 years of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be at least 6 years of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17771_17772_R","Initial treatment","AUTHORITY_REQUIRED","17772","17771","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have at least one mutation in the CFTR gene that is considered responsive to elexacaftor/tezacaftor/ivacaftor potentiation based on clinical and/or in vitro assay data; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be 2 to 5 years of age.</p> <p align=""justify"">For the purposes of this restriction, the list of mutations considered to be responsive to elexacaftor/tezacaftor/ivacaftor is defined in the TGA approved Product Information (PI). Mutations that are not listed in the TGA approved PI but considered to be responsive to elexacaftor/tezacaftor/ivacaftor can be accepted with a confirmation that these patients do not harbour two Class I mutations.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating the specific mutation considered to be responsive to elexacaftor/tezacaftor/ivacaftor as listed in the TGA approved PI - quote each of the: (i) specific mutation, and if the specific mutation is not listed in the TGA approved PI, confirmation that the patient does not harbour two Class I mutations, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have at least one mutation in the CFTR gene that is considered responsive to elexacaftor/tezacaftor/ivacaftor potentiation based on clinical and/or in vitro assay data; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be 2 to 5 years of age.</p> <p align=""justify"">For the purposes of this restriction, the list of mutations considered to be responsive to elexacaftor/tezacaftor/ivacaftor is defined in the TGA approved Product Information (PI). Mutations that are not listed in the TGA approved PI but considered to be responsive to elexacaftor/tezacaftor/ivacaftor can be accepted with a confirmation that these patients do not harbour two Class I mutations.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating the specific mutation considered to be responsive to elexacaftor/tezacaftor/ivacaftor as listed in the TGA approved PI - quote each of the: (i) specific mutation, and if the specific mutation is not listed in the TGA approved PI, confirmation that the patient does not harbour two Class I mutations, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17775_17855_R","null","AUTHORITY_REQUIRED","17855","17775","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17776_17851_R","Initial treatment","AUTHORITY_REQUIRED","17851","17776","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with a non-steroidal aromatase inhibitor; or</p> <p>The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Must be treated by a medical practitioner; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with a non-steroidal aromatase inhibitor; or</p> <p>The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Must be treated by a medical practitioner; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17777_17975_R","null","AUTHORITY_REQUIRED","17975","17777","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early breast cancer</p><br/><p>The treatment must be adjuvant to surgical resection; AND</p> <p>Patient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing this drug; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system); AND</p> <p>The treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 3 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression; AND</p> <p>The treatment must not be in combination with any of the following: (i) abemaciclib, (ii) olaparib, (iii) pembrolizumab; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine; AND</p> <p>Patient must be undergoing concurrent treatment with a non-steroidal aromatase inhibitor where this drug is being prescribed as a PBS benefit.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early breast cancer</p><br/><p>The treatment must be adjuvant to surgical resection; AND</p> <p>Patient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing this drug; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system); AND</p> <p>The treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 3 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression; AND</p> <p>The treatment must not be in combination with any of the following: (i) abemaciclib, (ii) olaparib, (iii) pembrolizumab; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine; AND</p> <p>Patient must be undergoing concurrent treatment with a non-steroidal aromatase inhibitor where this drug is being prescribed as a PBS benefit.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17778_17847_R","Continuing treatment","AUTHORITY_REQUIRED","17847","17778","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17779_18015_R","null","AUTHORITY_REQUIRED","18015","17779","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced breast cancer</p><br/><p>Patient must have failed standard prior therapy, which includes an anthracycline; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced breast cancer</p><br/><p>Patient must have failed standard prior therapy, which includes an anthracycline; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17780_17854_R","null","RESTRICTED","17854","17780","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Glioblastoma multiforme</p><br/><p>Patient must be undergoing concomitant radiotherapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Glioblastoma multiforme</p><br/><p>Patient must be undergoing concomitant radiotherapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17781_17858_R","Continuing treatment of first-line EGFR tyrosine kinase inhibitor therapy","AUTHORITY_REQUIRED","17858","17781","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment of first-line EGFR tyrosine kinase inhibitor therapy</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must be undergoing continuing treatment with this drug as first-line therapy (i.e. there are 2 Continuing treatment listings for this drug - ensure the correct Continuing treatment restriction is being accessed); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment of first-line EGFR tyrosine kinase inhibitor therapy</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must be undergoing continuing treatment with this drug as first-line therapy (i.e. there are 2 Continuing treatment listings for this drug - ensure the correct Continuing treatment restriction is being accessed); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17782_18016_R","Adjuvant therapy","AUTHORITY_REQUIRED","18016","17782","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IB, II or IIIA non-small cell lung cancer</p><br/><p>Adjuvant therapy</p><br/><p>Patient must be both: (i) initiating treatment, (ii) untreated with EGFR-TKI for non small cell lung cancer; or</p> <p>Patient must be continuing existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS-subsidised supply of this drug, (ii) untreated with EGFR-TKI at the time this drug was initiated; AND</p> <p>The treatment must be for the purpose of adjuvant therapy following surgical resection; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be commenced within 26 weeks of surgery; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 3 years in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the word ''cancelled''; where (i)/(ii) has occurred; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IB, II or IIIA non-small cell lung cancer</p><br/><p>Adjuvant therapy</p><br/><p>Patient must be both: (i) initiating treatment, (ii) untreated with EGFR-TKI for non small cell lung cancer; or</p> <p>Patient must be continuing existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS-subsidised supply of this drug, (ii) untreated with EGFR-TKI at the time this drug was initiated; AND</p> <p>The treatment must be for the purpose of adjuvant therapy following surgical resection; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be commenced within 26 weeks of surgery; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 3 years in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the word ''cancelled''; where (i)/(ii) has occurred; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17783_17784_R","Continuing treatment of second-line EGFR tyrosine kinase inhibitor therapy","AUTHORITY_REQUIRED","17784","17783","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment of second-line EGFR tyrosine kinase inhibitor therapy</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must be undergoing continuing treatment with this drug as second-line therapy (i.e. there are 2 Continuing treatment listings for this drug - ensure the correct Continuing treatment restriction is being accessed); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment of second-line EGFR tyrosine kinase inhibitor therapy</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must be undergoing continuing treatment with this drug as second-line therapy (i.e. there are 2 Continuing treatment listings for this drug - ensure the correct Continuing treatment restriction is being accessed); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17785_18017_R","Continuing treatment","STREAMLINED","18017","17785","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; or</p> <p>Patient must be undergoing monotherapy with this drug after completing an equivalent of 24 cumulative months of pembrolizumab treatment, measured from the first administered dose; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; or</p> <p>Patient must be undergoing monotherapy with this drug after completing an equivalent of 24 cumulative months of pembrolizumab treatment, measured from the first administered dose; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17787_17860_R","Continuing treatment","STREAMLINED","17860","17787","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; or</p> <p>Patient must be undergoing monotherapy with this drug after completing an equivalent of 24 cumulative months of pembrolizumab treatment, measured from the first administered dose; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">In a patient who has experienced an intolerance to pembrolizumab, details of intolerance must be documented in the patient&apos;s medical record.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; or</p> <p>Patient must be undergoing monotherapy with this drug after completing an equivalent of 24 cumulative months of pembrolizumab treatment, measured from the first administered dose; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">In a patient who has experienced an intolerance to pembrolizumab, details of intolerance must be documented in the patient&apos;s medical record.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17788_17862_R","Continuing treatment","STREAMLINED","17862","17788","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must not have disease progression; AND</p> <p>The treatment must be as monotherapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must not have disease progression; AND</p> <p>The treatment must be as monotherapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17790_17791_R","Continuing treatment","STREAMLINED","17791","17790","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic differentiated thyroid cancer</p><br/><p>Continuing treatment</p><br/><p>The condition must be refractory to radioactive iodine; or</p> <p>Patient must be deemed ineligible for treatment with radioactive iodine; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic differentiated thyroid cancer</p><br/><p>Continuing treatment</p><br/><p>The condition must be refractory to radioactive iodine; or</p> <p>Patient must be deemed ineligible for treatment with radioactive iodine; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17792_17865_R","Continuing treatment","STREAMLINED","17865","17792","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic differentiated thyroid cancer</p><br/><p>Continuing treatment</p><br/><p>The condition must be refractory to radioactive iodine; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic differentiated thyroid cancer</p><br/><p>Continuing treatment</p><br/><p>The condition must be refractory to radioactive iodine; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17795_17945_R","Continuation of first-line maintenance therapy (BRCA1/2 gene mutation)","AUTHORITY_REQUIRED","17945","17795","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of first-line maintenance therapy (BRCA1/2 gene mutation)</p><br/><p>The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation); AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 24 months of combined non-PBS-subsidised and PBS-subsidised treatment for patients who are in complete response; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of first-line maintenance therapy (BRCA1/2 gene mutation)</p><br/><p>The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation); AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 24 months of combined non-PBS-subsidised and PBS-subsidised treatment for patients who are in complete response; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17797_17981_R","Continuing treatment","AUTHORITY_REQUIRED","17981","17797","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug as adjuvant therapy for this condition; AND</p> <p>Patient must not have developed disease recurrence while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not be a PBS-subsidised benefit beyond a total of 52 weeks of treatment (including any non-PBS-subsidised supply); AND</p> <p>The treatment must not in combination with any of the following: (i) abemaciclib, (ii) pembrolizumab, (iii) ribociclib; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised treatment with this drug as adjuvant therapy for this condition; AND</p> <p>Patient must not have developed disease recurrence while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not be a PBS-subsidised benefit beyond a total of 52 weeks of treatment (including any non-PBS-subsidised supply); AND</p> <p>The treatment must not in combination with any of the following: (i) abemaciclib, (ii) pembrolizumab, (iii) ribociclib; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17798_17909_R","Initial treatment","AUTHORITY_REQUIRED","17909","17798","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic breast cancer</p><br/><p>Initial treatment</p><br/><p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene variant; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>Patient must have received chemotherapy in the neoadjuvant, adjuvant or metastatic setting; AND</p> <p>Patient must not have received PBS-subsidised treatment with this drug in any earlier line of treatment for breast cancer; AND</p> <p>The condition must be triple negative breast cancer; or</p> <p>The condition must be hormone-receptor positive breast cancer and the patient has either: (i) progressive disease after receiving endocrine therapy, (ii) been considered inappropriate for endocrine therapy; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records. Do not submit copies of these as part of the authority application.</p> <p align=""justify"">Treatment with this drug for this condition is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic breast cancer</p><br/><p>Initial treatment</p><br/><p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene variant; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>Patient must have received chemotherapy in the neoadjuvant, adjuvant or metastatic setting; AND</p> <p>Patient must not have received PBS-subsidised treatment with this drug in any earlier line of treatment for breast cancer; AND</p> <p>The condition must be triple negative breast cancer; or</p> <p>The condition must be hormone-receptor positive breast cancer and the patient has either: (i) progressive disease after receiving endocrine therapy, (ii) been considered inappropriate for endocrine therapy; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records. Do not submit copies of these as part of the authority application.</p> <p align=""justify"">Treatment with this drug for this condition is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17799_17946_R","Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets","AUTHORITY_REQUIRED","17946","17799","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets</p><br/><p>Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets</p><br/><p>Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17801_17870_R","Continuing treatment","AUTHORITY_REQUIRED","17870","17801","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17803_17802_R","Initial treatment","AUTHORITY_REQUIRED","17802","17803","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-02-01","Y","4708"
"17804_18004_R","Initial treatment","AUTHORITY_REQUIRED","18004","17804","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; or</p> <p>Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; or</p> <p>Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-02-01","Y","4708"
"17806_17949_R","Continuing treatment","STREAMLINED","17949","17806","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must have stable or responding disease; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must have stable or responding disease; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17808_17939_R","null","AUTHORITY_REQUIRED","17939","17808","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>The treatment must not be used in combination with chemotherapy; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must not be a PBS benefit where disease progression occurs whilst being treated with any of: (i) a combination treatment containing the individual drugs in one pharmaceutical benefit, (ii) the individual drugs obtained as separate pharmaceutical benefits; AND</p> <p>Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); or</p> <p>Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>The treatment must not be used in combination with chemotherapy; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must not be a PBS benefit where disease progression occurs whilst being treated with any of: (i) a combination treatment containing the individual drugs in one pharmaceutical benefit, (ii) the individual drugs obtained as separate pharmaceutical benefits; AND</p> <p>Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); or</p> <p>Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17810_17877_R","null","AUTHORITY_REQUIRED","17877","17810","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic castration sensitive carcinoma of the prostate</p><br/><p>The treatment must be/have been initiated within 6 months of treatment initiation with androgen deprivation therapy; AND</p> <p>Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); or</p> <p>Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND</p> <p>Patient must be undergoing concurrent androgen deprivation therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic castration sensitive carcinoma of the prostate</p><br/><p>The treatment must be/have been initiated within 6 months of treatment initiation with androgen deprivation therapy; AND</p> <p>Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); or</p> <p>Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND</p> <p>Patient must be undergoing concurrent androgen deprivation therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17813_17812_R","null","RESTRICTED","17812","17813","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (stage C) or metastatic (stage D) carcinoma of the prostate</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (stage C) or metastatic (stage D) carcinoma of the prostate</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17815_18037_R","null","RESTRICTED","18037","17815","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) breast cancer</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>Patient must be receiving PBS-subsidised everolimus concomitantly for this condition; AND</p> <p>Patient must not be pre-menopausal; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) breast cancer</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>Patient must be receiving PBS-subsidised everolimus concomitantly for this condition; AND</p> <p>Patient must not be pre-menopausal; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17816_17879_R","Initial treatment","AUTHORITY_REQUIRED","17879","17816","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>Patient must have failed treatment with chemotherapy; AND</p> <p>Patient must have failed treatment with imatinib; AND</p> <p>Patient must have failed an allogeneic haemopoietic stem cell transplantation if applicable; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Failure of treatment is defined as either:</p><p align=""justify"">(i) Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy and imatinib;</p><p align=""justify"">(ii) Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy and imatinib;</p><p align=""justify"">(iii) Morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation.</p><p align=""justify"">Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells expressing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">(c) a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>Patient must have failed treatment with chemotherapy; AND</p> <p>Patient must have failed treatment with imatinib; AND</p> <p>Patient must have failed an allogeneic haemopoietic stem cell transplantation if applicable; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Failure of treatment is defined as either:</p><p align=""justify"">(i) Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy and imatinib;</p><p align=""justify"">(ii) Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy and imatinib;</p><p align=""justify"">(iii) Morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation.</p><p align=""justify"">Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells expressing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">(c) a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided.</p> <p align=""justify"">Dasatinib will only be subsidised for patients with acute lymphoblastic leukaemia who are not receiving concomitant PBS-subsidised imatinib mesilate and who are not appropriate for an allogeneic haemopoietic stem cell transplant.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-02-01","Y","4708"
"17818_17821_R","Induction and Consolidation therapy","AUTHORITY_REQUIRED","17821","17818","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Induction and Consolidation therapy</p><br/><p>Patient must be newly diagnosed; AND</p> <p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>The treatment must be in combination with chemotherapy or corticosteroids; AND</p> <p>Patient must not have previously experienced a failure to respond to the PBS-subsidised first line treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first-line therapy for this condition; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">(c) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. (The date of the relevant pathology report needs to be provided).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Induction and Consolidation therapy</p><br/><p>Patient must be newly diagnosed; AND</p> <p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>The treatment must be in combination with chemotherapy or corticosteroids; AND</p> <p>Patient must not have previously experienced a failure to respond to the PBS-subsidised first line treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first-line therapy for this condition; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">(c) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. (The date of the relevant pathology report needs to be provided).</p> <p align=""justify"">Allogeneic stem cell transplantation is the preferred therapy for eligible patients achieving a complete remission of Philadelphia positive acute lymphoblastic leukaemia.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-02-01","Y","4708"
"17819_17817_R","Maintenance of first complete remission","AUTHORITY_REQUIRED","17817","17819","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Maintenance of first complete remission</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with imatinib as a first-line therapy for this condition; AND</p> <p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug that is occurring within the first 24 months from the first administered dose; or</p> <p>Patient must be undergoing treatment with this drug that is occurring beyond the first 24 months from the first administered dose - the patient meets the conditions as outlined below; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Conditions for PBS-subsidy beyond 24 months of treatment:</p><p align=""justify"">On the first occasion an authority application extends PBS-subsidy beyond 24 months, confirm that:</p><p align=""justify"">1) The condition is expressing the Philadelphia chromosome,</p><p align=""justify"">2) Measurable residual disease (MRD) is present,</p><p align=""justify"">3) MRD has been confirmed in at least one of: (i) marrow, (ii) peripheral blood,</p><p align=""justify"">4) MRD has been confirmed within the preceding 6 months of this authority application,</p><p align=""justify"">5) MRD has been ascertained by at least one of: (i) a molecular method, (ii) flow cytometry,</p><p align=""justify"">6) Allogenic stem cell transplantation is considered by the prescriber to be unsuitable for the patient.</p><p align=""justify"">For any subsequent authority application beyond the 24 month time mark, confirm that MRD has been detected within the preceding 12 months of this subsequent authority application. Where MRD has since become undetectable, confirm that PBS-subsidy has not exceeded a further 12 months duration from the date that MRD became undetectable.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Maintenance of first complete remission</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with imatinib as a first-line therapy for this condition; AND</p> <p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Patient must be undergoing treatment with this drug that is occurring within the first 24 months from the first administered dose; or</p> <p>Patient must be undergoing treatment with this drug that is occurring beyond the first 24 months from the first administered dose - the patient meets the conditions as outlined below; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Conditions for PBS-subsidy beyond 24 months of treatment:</p><p align=""justify"">On the first occasion an authority application extends PBS-subsidy beyond 24 months, confirm that:</p><p align=""justify"">1) The condition is expressing the Philadelphia chromosome,</p><p align=""justify"">2) Measurable residual disease (MRD) is present,</p><p align=""justify"">3) MRD has been confirmed in at least one of: (i) marrow, (ii) peripheral blood,</p><p align=""justify"">4) MRD has been confirmed within the preceding 6 months of this authority application,</p><p align=""justify"">5) MRD has been ascertained by at least one of: (i) a molecular method, (ii) flow cytometry,</p><p align=""justify"">6) Allogenic stem cell transplantation is considered by the prescriber to be unsuitable for the patient.</p><p align=""justify"">For any subsequent authority application beyond the 24 month time mark, confirm that MRD has been detected within the preceding 12 months of this subsequent authority application. Where MRD has since become undetectable, confirm that PBS-subsidy has not exceeded a further 12 months duration from the date that MRD became undetectable.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17820_17922_R","Continuing treatment - second-line therapy","STREAMLINED","17922","17820","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment - second-line therapy</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug as a second-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with nilotinib for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment - second-line therapy</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug as a second-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with nilotinib for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17823_17958_R","null","RESTRICTED","17958","17823","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Breast cancer</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Breast cancer</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17824_17886_R","Continuing treatment","STREAMLINED","17886","17824","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Malignant gastrointestinal stromal tumour</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given at a dose not exceeding 600 mg per day; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib</p> <p align=""justify"">Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.</p><p align=""justify"">A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Malignant gastrointestinal stromal tumour</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given at a dose not exceeding 600 mg per day; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib</p> <p align=""justify"">Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.</p><p align=""justify"">A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.)</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17825_17890_R","Continuing treatment","STREAMLINED","17890","17825","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastrointestinal stromal tumour</p><br/><p>Continuing treatment</p><br/><p>The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND</p> <p>Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND</p> <p>The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy); AND</p> <p>Patient must have previously been issued with an authority prescription for imatinib for adjuvant treatment following complete resection of primary GIST; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastrointestinal stromal tumour</p><br/><p>Continuing treatment</p><br/><p>The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND</p> <p>Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND</p> <p>The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy); AND</p> <p>Patient must have previously been issued with an authority prescription for imatinib for adjuvant treatment following complete resection of primary GIST; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17827_17889_R","Continuing treatment - first-line therapy","STREAMLINED","17889","17827","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment - first-line therapy</p><br/><p>The condition must be in the chronic phase; AND</p> <p>Patient must have received initial continuing PBS-subsidised treatment with this drug as a first-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with dasatinib for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with nilotinib for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment - first-line therapy</p><br/><p>The condition must be in the chronic phase; AND</p> <p>Patient must have received initial continuing PBS-subsidised treatment with this drug as a first-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with dasatinib for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with nilotinib for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17828_17829_R","Continuing treatment","STREAMLINED","17829","17828","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; AND</p> <p>The condition must be in the accelerated phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; AND</p> <p>The condition must be in the accelerated phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17831_17930_R","Initial treatment","AUTHORITY_REQUIRED","17930","17831","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mantle cell lymphoma</p><br/><p>Initial treatment</p><br/><p>The condition must have relapsed or be refractory to at least one prior therapy; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be untreated with Bruton''s tyrosine kinase inhibitor therapy; or</p> <p>Patient must have developed intolerance to another Bruton''s tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication; AND</p> <p>Must be treated by a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mantle cell lymphoma</p><br/><p>Initial treatment</p><br/><p>The condition must have relapsed or be refractory to at least one prior therapy; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be untreated with Bruton''s tyrosine kinase inhibitor therapy; or</p> <p>Patient must have developed intolerance to another Bruton''s tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication; AND</p> <p>Must be treated by a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17832_17898_R","Treatment of relapsed/refractory disease","AUTHORITY_REQUIRED","17898","17832","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Treatment of relapsed/refractory disease</p><br/><p>The condition must have relapsed or be refractory to at least one prior therapy; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must not be undergoing retreatment (second/subsequent treatment course) with this drug where prior treatment of CLL/SLL with this same drug was unable to prevent disease progression; AND</p> <p>Patient must be undergoing treatment through this treatment phase listing for the first time (initial treatment); or</p> <p>Patient must be undergoing continuing treatment through this treatment phase listing, with disease progression being absent; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Treatment of relapsed/refractory disease</p><br/><p>The condition must have relapsed or be refractory to at least one prior therapy; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must not be undergoing retreatment (second/subsequent treatment course) with this drug where prior treatment of CLL/SLL with this same drug was unable to prevent disease progression; AND</p> <p>Patient must be undergoing treatment through this treatment phase listing for the first time (initial treatment); or</p> <p>Patient must be undergoing continuing treatment through this treatment phase listing, with disease progression being absent; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17836_17834_R","Continuing treatment","AUTHORITY_REQUIRED","17834","17836","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have progressive disease; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have progressive disease; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Authority applications for continuing treatment may be made by telephone to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17837_17931_R","Continuing treatment","AUTHORITY_REQUIRED","17931","17837","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mantle cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mantle cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17839_17838_R","First continuing treatment (treatment cycles 4 to 9 inclusive) of first-line therapy","AUTHORITY_REQUIRED","17838","17839","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First continuing treatment (treatment cycles 4 to 9 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses); AND</p> <p>The treatment must cease upon disease progression; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First continuing treatment (treatment cycles 4 to 9 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses); AND</p> <p>The treatment must cease upon disease progression; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17841_17765_R","Initial treatment","AUTHORITY_REQUIRED","17765","17841","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be at least 1 year of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and</p><p align=""justify"">(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be at least 1 year of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and</p><p align=""justify"">(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17843_17969_R","Continuing treatment","AUTHORITY_REQUIRED","17969","17843","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis - homozygous for the F508del mutation</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.</p> <p align=""justify"">Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort;</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and</p><p align=""justify"">(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis - homozygous for the F508del mutation</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.</p> <p align=""justify"">Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort;</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and</p><p align=""justify"">(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17845_17846_R","Initial treatment","AUTHORITY_REQUIRED","17846","17845","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have at least one mutation in the CFTR gene that is considered responsive to elexacaftor/tezacaftor/ivacaftor potentiation based on clinical and/or in vitro assay data; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be aged between 2 and 11 years inclusive.</p> <p align=""justify"">For the purposes of this restriction, the list of mutations considered to be responsive to elexacaftor/tezacaftor/ivacaftor is defined in the TGA approved Product Information (PI). Mutations that are not listed in the TGA approved PI but considered to be responsive to elexacaftor/tezacaftor/ivacaftor can be accepted with a confirmation that these patients do not harbour two Class I mutations.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating the specific mutation considered to be responsive to elexacaftor/tezacaftor/ivacaftor as listed in the TGA approved PI - quote each of the: (i) specific mutation, and if the specific mutation is not listed in the TGA approved PI, confirmation that the patient does not harbour two Class I mutations, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have at least one mutation in the CFTR gene that is considered responsive to elexacaftor/tezacaftor/ivacaftor potentiation based on clinical and/or in vitro assay data; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be aged between 2 and 11 years inclusive.</p> <p align=""justify"">For the purposes of this restriction, the list of mutations considered to be responsive to elexacaftor/tezacaftor/ivacaftor is defined in the TGA approved Product Information (PI). Mutations that are not listed in the TGA approved PI but considered to be responsive to elexacaftor/tezacaftor/ivacaftor can be accepted with a confirmation that these patients do not harbour two Class I mutations.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating the specific mutation considered to be responsive to elexacaftor/tezacaftor/ivacaftor as listed in the TGA approved PI - quote each of the: (i) specific mutation, and if the specific mutation is not listed in the TGA approved PI, confirmation that the patient does not harbour two Class I mutations, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17848_17848_R","null","RESTRICTED","17848","17848","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For prescribing by certain health practitioners</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For prescribing by certain health practitioners</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17849_17907_R","null","AUTHORITY_REQUIRED","17907","17849","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early breast cancer</p><br/><p>The treatment must be adjuvant to surgical resection; AND</p> <p>Patient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing this drug; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system); AND</p> <p>The treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 2 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression; AND</p> <p>The treatment must not be in combination with any of the following: (i) olaparib, (ii) pembrolizumab, (iii) ribociclib; AND</p> <p>Patient must be undergoing concurrent treatment with endocrine therapy where this drug is being prescribed as a PBS benefit; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early breast cancer</p><br/><p>The treatment must be adjuvant to surgical resection; AND</p> <p>Patient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing this drug; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system); AND</p> <p>The treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 2 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression; AND</p> <p>The treatment must not be in combination with any of the following: (i) olaparib, (ii) pembrolizumab, (iii) ribociclib; AND</p> <p>Patient must be undergoing concurrent treatment with endocrine therapy where this drug is being prescribed as a PBS benefit; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17850_17906_R","Continuing treatment","AUTHORITY_REQUIRED","17906","17850","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17852_17940_R","Initial treatment","AUTHORITY_REQUIRED","17940","17852","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; or</p> <p>The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Patient must require dosage reduction requiring a pack of 42 tablets; AND</p> <p>Must be treated by a medical practitioner; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; or</p> <p>The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Patient must require dosage reduction requiring a pack of 42 tablets; AND</p> <p>Must be treated by a medical practitioner; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17857_17856_R","Continuing treatment beyond 3 months","STREAMLINED","17856","17857","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17859_17943_R","Initial treatment","STREAMLINED","17943","17859","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Initial treatment</p><br/><p>Patient must have received prior treatment with platinum-based chemotherapy; AND</p> <p>The condition must be untreated with each of: (i) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (ii) tyrosine kinase inhibitor therapy; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; AND</p> <p>Must be treated by a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced, metastatic or recurrent endometrial carcinoma</p><br/><p>Initial treatment</p><br/><p>Patient must have received prior treatment with platinum-based chemotherapy; AND</p> <p>The condition must be untreated with each of: (i) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (ii) tyrosine kinase inhibitor therapy; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; AND</p> <p>Must be treated by a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17861_17786_R","Initial treatment","STREAMLINED","17786","17861","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>Patient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug and pembrolizumab of either: (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient''s medical records; AND</p> <p>The condition must be untreated; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; AND</p> <p>Must be treated by a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>Patient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug and pembrolizumab of either: (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient''s medical records; AND</p> <p>The condition must be untreated; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify""><i>A</i> prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk score can be calculated here: https://www.mdcalc.com/imdc-international-metastatic-rcc-database-consortium-risk-model-metastatic-renal-cell-carcinoma.</p><p align=""justify"">One point is assigned for each of:</p><p align=""justify"">(i) a time of diagnosis to systemic therapy of less than 1 year</p><p align=""justify"">(ii) a Karnofsky Performance Status of less than 80%</p><p align=""justify"">(iii) a haemoglobin less than the lower limit of normal</p><p align=""justify"">(iv) a corrected calcium level greater than the upper limit of normal</p><p align=""justify"">(v) a neutrophil count greater than the upper limit of normal</p><p align=""justify"">(vi) a platelet count greater than the upper limit of normal</p><p align=""justify"">Stated normal reference ranges may vary depending on the laboratory providing the measurement. &apos;Normal&apos; here refers to the individual laboratory&apos;s stated normal reference range.</p><p align=""justify"">Favourable IMDC risk is a score of 0.</p><p align=""justify"">Intermediate IMDC risk is a score of 1 to 2.</p><p align=""justify"">Poor IMDC risk is a score of 3 to 6.</p><p align=""justify"">Document any IMDC risk score assessment in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17863_17789_R","Continuing treatment","STREAMLINED","17789","17863","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable malignant gastrointestinal stromal tumour</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must not be resectable; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or unresectable malignant gastrointestinal stromal tumour</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must not be resectable; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17866_17867_R","null","AUTHORITY_REQUIRED","17867","17866","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND</p> <p>Patient must not have received prior PBS-subsidised novel hormonal drug in any non-metastatic setting of prostate cancer prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance score no higher than 1 prior to treatment initiation; AND</p> <p>Patient must be undergoing concurrent treatment with enzalutamide, unless an intolerance to enzalutamide requires either a: (i) temporary cessation, (ii) permanent discontinuation; AND</p> <p>The treatment must not be a PBS-subsidised benefit beyond disease progression; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND</p> <p>Patient must not have received prior PBS-subsidised novel hormonal drug in any non-metastatic setting of prostate cancer prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance score no higher than 1 prior to treatment initiation; AND</p> <p>Patient must be undergoing concurrent treatment with enzalutamide, unless an intolerance to enzalutamide requires either a: (i) temporary cessation, (ii) permanent discontinuation; AND</p> <p>The treatment must not be a PBS-subsidised benefit beyond disease progression; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17868_18002_R","Continuing treatment","AUTHORITY_REQUIRED","18002","17868","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received previous PBS-subsidised treatment with this drug in the metastatic setting; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received previous PBS-subsidised treatment with this drug in the metastatic setting; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17869_17910_R","Continuation of subsequent-line maintenance therapy (BRCA1/2 gene mutation)","STREAMLINED","17910","17869","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of subsequent-line maintenance therapy (BRCA1/2 gene mutation)</p><br/><p>The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial subsequent-line maintenance therapy (BRCA1/2 gene mutation); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of subsequent-line maintenance therapy (BRCA1/2 gene mutation)</p><br/><p>The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial subsequent-line maintenance therapy (BRCA1/2 gene mutation); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17871_17914_R","Initial treatment","AUTHORITY_REQUIRED","17914","17871","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Must be treated by a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Must be treated by a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17872_17950_R","Initial treatment","AUTHORITY_REQUIRED","17950","17872","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be adjuvant to complete surgical resection; AND</p> <p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy; AND</p> <p>Must be treated by a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be adjuvant to complete surgical resection; AND</p> <p>The condition must be positive for a BRAF V600 mutation; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND</p> <p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy; AND</p> <p>Must be treated by a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17874_17873_R","null","AUTHORITY_REQUIRED","17873","17874","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>The treatment must be used in combination with a corticosteroid; AND</p> <p>The treatment must not be used in combination with chemotherapy; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must not be a PBS benefit where disease progression occurs whilst being treated with any of: (i) a combination treatment containing the individual drugs in one pharmaceutical benefit, (ii) the individual drugs obtained as separate pharmaceutical benefits; AND</p> <p>Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); or</p> <p>Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>The treatment must be used in combination with a corticosteroid; AND</p> <p>The treatment must not be used in combination with chemotherapy; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must not be a PBS benefit where disease progression occurs whilst being treated with any of: (i) a combination treatment containing the individual drugs in one pharmaceutical benefit, (ii) the individual drugs obtained as separate pharmaceutical benefits; AND</p> <p>Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); or</p> <p>Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17876_17875_R","null","AUTHORITY_REQUIRED","17875","17876","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant non-metastatic carcinoma of the prostate</p><br/><p>The condition must have evidence of an absence of distant metastases on the most recently performed conventional medical imaging used to evaluate the condition; AND</p> <p>The condition must be associated with a prostate-specific antigen level that was observed to have at least doubled in value in a time period of within 10 months anytime prior to first commencing treatment with this drug; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND</p> <p>Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); or</p> <p>Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND</p> <p>Patient must be undergoing concurrent treatment with androgen deprivation therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Prescribing instructions:</p><p align=""justify"">Retain the results of all investigative imaging and prostate-specific antigen (PSA) level measurements on the patient&apos;s medical records - do not submit copies of these with this authority application.</p><p align=""justify"">The PSA level doubling time must be based on at least three PSA levels obtained within a time period of 10 months any time prior to first commencing a novel hormonal drug for this condition. The third reading is to demonstrate that the doubling was durable and must be at least 1 week apart from the second reading.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant non-metastatic carcinoma of the prostate</p><br/><p>The condition must have evidence of an absence of distant metastases on the most recently performed conventional medical imaging used to evaluate the condition; AND</p> <p>The condition must be associated with a prostate-specific antigen level that was observed to have at least doubled in value in a time period of within 10 months anytime prior to first commencing treatment with this drug; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND</p> <p>Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); or</p> <p>Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND</p> <p>Patient must be undergoing concurrent treatment with androgen deprivation therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Prescribing instructions:</p><p align=""justify"">Retain the results of all investigative imaging and prostate-specific antigen (PSA) level measurements on the patient&apos;s medical records - do not submit copies of these with this authority application.</p><p align=""justify"">The PSA level doubling time must be based on at least three PSA levels obtained within a time period of 10 months any time prior to first commencing a novel hormonal drug for this condition. The third reading is to demonstrate that the doubling was durable and must be at least 1 week apart from the second reading.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17878_17814_R","null","RESTRICTED","17814","17878","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Carcinoma of the prostate</p><br/><p>The condition must be metastatic (stage D); AND</p> <p>Patient must require a combination of an antiandrogen and a GnRH (LH-RH) agonist; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Carcinoma of the prostate</p><br/><p>The condition must be metastatic (stage D); AND</p> <p>Patient must require a combination of an antiandrogen and a GnRH (LH-RH) agonist; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17882_17880_R","null","RESTRICTED","17880","17882","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Breast cancer</p><br/><p>The condition must be hormone receptor positive; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Breast cancer</p><br/><p>The condition must be hormone receptor positive; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17883_17884_R","Continuing treatment","STREAMLINED","17884","17883","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dermatofibrosarcoma protuberans</p><br/><p>Continuing treatment</p><br/><p>The condition must be unresectable; or</p> <p>The condition must be locally recurrent; or</p> <p>The condition must be metastatic; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to the PBS-subsidised treatment; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 800 mg per day; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Evidence that the disease has not progressed on imatinib therapy must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dermatofibrosarcoma protuberans</p><br/><p>Continuing treatment</p><br/><p>The condition must be unresectable; or</p> <p>The condition must be locally recurrent; or</p> <p>The condition must be metastatic; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated a response to the PBS-subsidised treatment; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 800 mg per day; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Evidence that the disease has not progressed on imatinib therapy must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17888_17885_R","Continuing treatment","STREAMLINED","17885","17888","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic eosinophilic leukaemia or Hypereosinophilic syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved and maintained a complete haematological response; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A full blood examination report which demonstrates a complete haematological response, with a normal eosinophil count and a statement that the disease has not progressed on imatinib therapy must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic eosinophilic leukaemia or Hypereosinophilic syndrome</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved and maintained a complete haematological response; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A full blood examination report which demonstrates a complete haematological response, with a normal eosinophil count and a statement that the disease has not progressed on imatinib therapy must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17891_17826_R","Maintenance of first complete remission","STREAMLINED","17826","17891","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Maintenance of first complete remission</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with dasatinib as a first-line therapy for this condition; AND</p> <p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine; AND</p> <p>Patient must be undergoing treatment with this drug that is occurring within the first 24 months from the first administered dose; or</p> <p>Patient must be undergoing treatment with this drug that is occurring beyond the first 24 months from the first administered dose - the patient meets the conditions as outlined below.</p> <p align=""justify"">Conditions for PBS-subsidy beyond 24 months of treatment:</p><p align=""justify"">On the first occasion an authority application extends PBS-subsidy beyond 24 months, by annotating the prescription with the Streamlined Authority Required code, the prescriber is declaring that:</p><p align=""justify"">1) The condition is expressing the Philadelphia chromosome,</p><p align=""justify"">2) Measurable residual disease (MRD) is present,</p><p align=""justify"">3) MRD has been confirmed in at least one of: (i) marrow, (ii) peripheral blood,</p><p align=""justify"">4) MRD has been confirmed within the preceding months of this authority application,</p><p align=""justify"">5) MRD has been ascertained by at least one of: (i) a molecular method, (ii) flow cytometry,</p><p align=""justify"">6) Allogenic stem cell transplantation is considered by the prescriber to be unsuitable for the patient.</p><p align=""justify"">For any subsequent authority application beyond the 24 month time mark, confirm that MRD has been detected within the preceding 12 months of this subsequent authority application. Where MRD has since become undetectable, confirm that PBS-subsidy has not exceeded a further 12 months duration from the date that MRD became undetectable.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Maintenance of first complete remission</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with dasatinib as a first-line therapy for this condition; AND</p> <p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine; AND</p> <p>Patient must be undergoing treatment with this drug that is occurring within the first 24 months from the first administered dose; or</p> <p>Patient must be undergoing treatment with this drug that is occurring beyond the first 24 months from the first administered dose - the patient meets the conditions as outlined below.</p> <p align=""justify"">Conditions for PBS-subsidy beyond 24 months of treatment:</p><p align=""justify"">On the first occasion an authority application extends PBS-subsidy beyond 24 months, by annotating the prescription with the Streamlined Authority Required code, the prescriber is declaring that:</p><p align=""justify"">1) The condition is expressing the Philadelphia chromosome,</p><p align=""justify"">2) Measurable residual disease (MRD) is present,</p><p align=""justify"">3) MRD has been confirmed in at least one of: (i) marrow, (ii) peripheral blood,</p><p align=""justify"">4) MRD has been confirmed within the preceding months of this authority application,</p><p align=""justify"">5) MRD has been ascertained by at least one of: (i) a molecular method, (ii) flow cytometry,</p><p align=""justify"">6) Allogenic stem cell transplantation is considered by the prescriber to be unsuitable for the patient.</p><p align=""justify"">For any subsequent authority application beyond the 24 month time mark, confirm that MRD has been detected within the preceding 12 months of this subsequent authority application. Where MRD has since become undetectable, confirm that PBS-subsidy has not exceeded a further 12 months duration from the date that MRD became undetectable.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17892_18008_R","Initial treatment","AUTHORITY_REQUIRED","18008","17892","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Initial treatment</p><br/><p>The condition must be confirmed Chronic lymphocytic leukaemia (CLL) prior to initiation of treatment; or</p> <p>The condition must be confirmed Small lymphocytic lymphoma (SLL) prior to initiation of treatment; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with rituximab for up to a maximum of 8 doses under this restriction, followed by monotherapy for this condition; AND</p> <p>The condition must have relapsed or be refractory to at least one prior therapy; AND</p> <p>The condition must be CD20 positive; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>Must be treated by a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Initial treatment</p><br/><p>The condition must be confirmed Chronic lymphocytic leukaemia (CLL) prior to initiation of treatment; or</p> <p>The condition must be confirmed Small lymphocytic lymphoma (SLL) prior to initiation of treatment; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with rituximab for up to a maximum of 8 doses under this restriction, followed by monotherapy for this condition; AND</p> <p>The condition must have relapsed or be refractory to at least one prior therapy; AND</p> <p>The condition must be CD20 positive; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>Must be treated by a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17894_18010_R","Continuing treatment - first-line therapy","STREAMLINED","18010","17894","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment - first-line therapy</p><br/><p>The condition must be in the chronic phase; AND</p> <p>Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with imatinib for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with dasatinib for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment - first-line therapy</p><br/><p>The condition must be in the chronic phase; AND</p> <p>Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with imatinib for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with dasatinib for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17896_17989_R","Initial treatment","AUTHORITY_REQUIRED","17989","17896","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report; AND</p> <p>Patient must have failed an adequate trial of imatinib confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Failure of an adequate trial of imatinib or dasatinib or nilotinib is defined as:</p><p align=""justify"">1. Lack of response to imatinib or dasatinib or nilotinib therapy, defined as either:</p><p align=""justify"">(i) failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib or nilotinib; or</p><p align=""justify"">(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or</p><p align=""justify"">(iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib or nilotinib; OR</p><p align=""justify"">2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib or nilotinib therapy; OR </p><p align=""justify"">3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib or nilotinib therapy; OR </p><p align=""justify"">4. Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR</p><p align=""justify"">5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during imatinib or dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. </p> <p/><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p/><p align=""justify"">2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or </p><p/><p align=""justify"">3. Peripheral basophils greater than or equal to 20%; or</p><p/><p align=""justify"">4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or </p><p/><p align=""justify"">5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).</p><p/> <p align=""justify"">Blast crisis is defined as either:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or</p><p/><p align=""justify"">2. Extramedullary involvement other than spleen and liver.</p><p/> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or</p><p align=""justify"">(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and</p><p align=""justify"">(iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; and</p><p align=""justify"">(iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Up to a maximum of 18 months of treatment may be authorised under this initial restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report; AND</p> <p>Patient must have failed an adequate trial of imatinib confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Failure of an adequate trial of imatinib or dasatinib or nilotinib is defined as:</p><p align=""justify"">1. Lack of response to imatinib or dasatinib or nilotinib therapy, defined as either:</p><p align=""justify"">(i) failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib or nilotinib; or</p><p align=""justify"">(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or</p><p align=""justify"">(iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib or nilotinib; OR</p><p align=""justify"">2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib or nilotinib therapy; OR </p><p align=""justify"">3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib or nilotinib therapy; OR </p><p align=""justify"">4. Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR</p><p align=""justify"">5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during imatinib or dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. </p> <p/><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p/><p align=""justify"">2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or </p><p/><p align=""justify"">3. Peripheral basophils greater than or equal to 20%; or</p><p/><p align=""justify"">4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or </p><p/><p align=""justify"">5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).</p><p/> <p align=""justify"">Blast crisis is defined as either:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or</p><p/><p align=""justify"">2. Extramedullary involvement other than spleen and liver.</p><p/> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or</p><p align=""justify"">(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and</p><p align=""justify"">(iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; and</p><p align=""justify"">(iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Up to a maximum of 18 months of treatment may be authorised under this initial restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-02-01","Y","4708"
"17897_18011_R","Initial treatment","AUTHORITY_REQUIRED","18011","17897","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal; or</p> <p>Patient must not be eligible for PBS-subsidised treatment with nilotinib because the patient has a blast crisis; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Failure of an adequate trial of dasatinib or nilotinib is defined as:</p><p align=""justify"">1. Lack of response to dasatinib or nilotinib therapy, defined as either:</p><p align=""justify"">(i) failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib or nilotinib; or </p><p align=""justify"">(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or</p><p align=""justify"">(iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib or nilotinib; OR </p><p align=""justify"">2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib or nilotinib therapy; OR </p><p align=""justify"">3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib or nilotinib therapy; OR </p><p align=""justify"">4. Development of accelerated phase or blast crisis in a patient previously prescribed dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR</p><p align=""justify"">5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.</p> <p/><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p/><p align=""justify"">2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or </p><p/><p align=""justify"">3. Peripheral basophils greater than or equal to 20%; or</p><p/><p align=""justify"">4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or </p><p/><p align=""justify"">5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).</p><p/> <p align=""justify"">Blast crisis is defined as either:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or</p><p/><p align=""justify"">2. Extramedullary involvement other than spleen and liver.</p><p/> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or</p><p align=""justify"">(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and</p><p align=""justify"">(iii) where there has been a loss of response to dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Up to a maximum of 18 months of treatment may be authorised under this initial restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal; or</p> <p>Patient must not be eligible for PBS-subsidised treatment with nilotinib because the patient has a blast crisis; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Failure of an adequate trial of dasatinib or nilotinib is defined as:</p><p align=""justify"">1. Lack of response to dasatinib or nilotinib therapy, defined as either:</p><p align=""justify"">(i) failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib or nilotinib; or </p><p align=""justify"">(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or</p><p align=""justify"">(iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib or nilotinib; OR </p><p align=""justify"">2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib or nilotinib therapy; OR </p><p align=""justify"">3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib or nilotinib therapy; OR </p><p align=""justify"">4. Development of accelerated phase or blast crisis in a patient previously prescribed dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR</p><p align=""justify"">5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.</p> <p/><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p/><p align=""justify"">2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or </p><p/><p align=""justify"">3. Peripheral basophils greater than or equal to 20%; or</p><p/><p align=""justify"">4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or </p><p/><p align=""justify"">5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).</p><p/> <p align=""justify"">Blast crisis is defined as either:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or</p><p/><p align=""justify"">2. Extramedullary involvement other than spleen and liver.</p><p/> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or</p><p align=""justify"">(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and</p><p align=""justify"">(iii) where there has been a loss of response to dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Up to a maximum of 18 months of treatment may be authorised under this initial restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-02-01","Y","4708"
"17899_17900_R","Second and final continuing treatment (treatment cycles 10 to 15 inclusive) of first-line therapy","AUTHORITY_REQUIRED","17900","17899","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Second and final continuing treatment (treatment cycles 10 to 15 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses); AND</p> <p>The treatment must cease upon disease progression; or</p> <p>The treatment must cease upon completion of 15 cycles of treatment with this drug for this condition, whichever comes first; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Second and final continuing treatment (treatment cycles 10 to 15 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses); AND</p> <p>The treatment must cease upon disease progression; or</p> <p>The treatment must cease upon completion of 15 cycles of treatment with this drug for this condition, whichever comes first; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17903_17842_R","Continuing treatment","AUTHORITY_REQUIRED","17842","17903","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and</p><p align=""justify"">(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and</p><p align=""justify"">(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17904_17968_R","Initial treatment","AUTHORITY_REQUIRED","17968","17904","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis - homozygous for the F508del mutation</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.</p> <p align=""justify"">Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort;</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and</p><p align=""justify"">(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis - homozygous for the F508del mutation</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.</p> <p align=""justify"">Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort;</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and</p><p align=""justify"">(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17905_17937_R","Continuing treatment","AUTHORITY_REQUIRED","17937","17905","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be at least 6 years of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be at least 6 years of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17908_17774_R","Initial treatment","AUTHORITY_REQUIRED","17774","17908","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; or</p> <p>The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Must be treated by a medical practitioner; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; or</p> <p>The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Must be treated by a medical practitioner; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17916_17807_R","Continuing treatment","STREAMLINED","17807","17916","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must be receiving PBS-subsidised vemurafenib concomitantly for this condition; AND</p> <p>Patient must have stable or responding disease; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must be receiving PBS-subsidised vemurafenib concomitantly for this condition; AND</p> <p>Patient must have stable or responding disease; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17920_17822_R","Continuing treatment - first-line therapy","STREAMLINED","17822","17920","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment - first-line therapy</p><br/><p>The condition must be in the chronic phase; AND</p> <p>Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with imatinib for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with nilotinib for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment - first-line therapy</p><br/><p>The condition must be in the chronic phase; AND</p> <p>Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with imatinib for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised first-line treatment with nilotinib for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17921_17984_R","Continuing treatment","AUTHORITY_REQUIRED","17984","17921","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Continuing treatment</p><br/><p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy following treatment with imatinib; AND</p> <p>The condition must not have progressed; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Continuing treatment</p><br/><p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy following treatment with imatinib; AND</p> <p>The condition must not have progressed; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Dasatinib will only be subsidised for patients with acute lymphoblastic leukaemia who are not receiving concomitant PBS-subsidised imatinib mesilate and who are not appropriate for an allogeneic haemopoietic stem cell transplant.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17924_17881_R","null","RESTRICTED","17881","17924","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometrial cancer</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometrial cancer</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17925_17960_R","Continuing treatment","STREAMLINED","17960","17925","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic or myeloproliferative disorder</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be PDGFRB fusion gene-positive; AND</p> <p>Patient must have achieved and maintained a complete haematological response; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A full blood examination report which demonstrates a complete haematological response and evidence that the disease has not progressed on imatinib therapy must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Myelodysplastic or myeloproliferative disorder</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be PDGFRB fusion gene-positive; AND</p> <p>Patient must have achieved and maintained a complete haematological response; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A full blood examination report which demonstrates a complete haematological response and evidence that the disease has not progressed on imatinib therapy must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17926_17830_R","Continuing treatment","STREAMLINED","17830","17926","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; AND</p> <p>The condition must be in the blast phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug as a first-line therapy for this condition; AND</p> <p>The condition must be in the blast phase; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17928_18031_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","18031","17928","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have maintained a major cytogenic response of less than 35% Philadelphia positive bone marrow cells at 12 month intervals; or</p> <p>Patient must have maintained a peripheral blood level of BCR-ABL of less than 1% on the international scale at 12 month intervals; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A pathology report demonstrating the patient&apos;s cytogenetic response or a peripheral blood level of BCR-ABL must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have maintained a major cytogenic response of less than 35% Philadelphia positive bone marrow cells at 12 month intervals; or</p> <p>Patient must have maintained a peripheral blood level of BCR-ABL of less than 1% on the international scale at 12 month intervals; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A pathology report demonstrating the patient&apos;s cytogenetic response or a peripheral blood level of BCR-ABL must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17929_17835_R","Initial treatment","AUTHORITY_REQUIRED","17835","17929","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>Patient must have failed prior treatment with PBS-subsidised dasatinib for this condition; or</p> <p>Patient must have developed intolerance to PBS-subsidised dasatinib of a severity requiring treatment withdrawal; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Failure of treatment with dasatinib is defined as either:</p><p align=""justify"">1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with PBS-subsidised dasatinib for this condition; or</p><p align=""justify"">2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by PBS-subsidised dasatinib for this condition; or</p><p align=""justify"">3. Rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.</p> <p align=""justify"">Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission; OR rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">1. details of the proposed prescription; and</p><p align=""justify"">2. a completed Acute Lymphoblastic Leukaemia ponatinib PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">3. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided; or</p><p align=""justify"">4. pathology reports documenting rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition. The date of the relevant pathology report(s) need(s) to be provided.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be expressing the Philadelphia chromosome; or</p> <p>The condition must have the transcript BCR-ABL; AND</p> <p>Patient must have failed prior treatment with PBS-subsidised dasatinib for this condition; or</p> <p>Patient must have developed intolerance to PBS-subsidised dasatinib of a severity requiring treatment withdrawal; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Failure of treatment with dasatinib is defined as either:</p><p align=""justify"">1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with PBS-subsidised dasatinib for this condition; or</p><p align=""justify"">2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by PBS-subsidised dasatinib for this condition; or</p><p align=""justify"">3. Rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.</p> <p align=""justify"">Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission; OR rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">1. details of the proposed prescription; and</p><p align=""justify"">2. a completed Acute Lymphoblastic Leukaemia ponatinib PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">3. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided; or</p><p align=""justify"">4. pathology reports documenting rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition. The date of the relevant pathology report(s) need(s) to be provided.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-02-01","Y","4708"
"17932_17932_R","Initial treatment","AUTHORITY_REQUIRED","17932","17932","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Patient must have at least one mutation in the CFTR gene that is considered responsive to vanzacaftor/tezacaftor/deutivacaftor potentiation based on clinical and/or in vitro assay data; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be at least 6 years of age.</p> <p align=""left"">For the purposes of this restriction, the list of mutations considered to be responsive to vanzacaftor/tezacaftor/deutivacaftor is defined in the TGA approved Product Information (PI). Mutations that are not listed in the TGA approved PI but considered to be responsive to vanzacaftor/tezacaftor/deutivacaftor can be accepted with a confirmation that these patients do not harbour two Class I mutations.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""left"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""left"">(1) details of the pathology report substantiating the specific mutation considered to be responsive to vanzacaftor/tezacaftor/deutivacaftor as listed in the TGA approved PI - quote each of the: (i) specific mutation, and if the specific mutation is not listed in the TGA approved PI, confirmation that the patient does not harbour two Class I mutations, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""left"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Patient must have at least one mutation in the CFTR gene that is considered responsive to vanzacaftor/tezacaftor/deutivacaftor potentiation based on clinical and/or in vitro assay data; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be at least 6 years of age.</p> <p align=""left"">For the purposes of this restriction, the list of mutations considered to be responsive to vanzacaftor/tezacaftor/deutivacaftor is defined in the TGA approved Product Information (PI). Mutations that are not listed in the TGA approved PI but considered to be responsive to vanzacaftor/tezacaftor/deutivacaftor can be accepted with a confirmation that these patients do not harbour two Class I mutations.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""left"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""left"">(1) details of the pathology report substantiating the specific mutation considered to be responsive to vanzacaftor/tezacaftor/deutivacaftor as listed in the TGA approved PI - quote each of the: (i) specific mutation, and if the specific mutation is not listed in the TGA approved PI, confirmation that the patient does not harbour two Class I mutations, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""left"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17936_17970_R","Initial treatment","AUTHORITY_REQUIRED","17970","17936","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have at least one mutation in the CFTR gene that is considered responsive to elexacaftor/tezacaftor/ivacaftor potentiation based on clinical and/or in vitro assay data; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be at least 6 years of age.</p> <p align=""justify"">For the purposes of this restriction, the list of mutations considered to be responsive to elexacaftor/tezacaftor/ivacaftor is defined in the TGA approved Product Information (PI). Mutations that are not listed in the TGA approved PI but considered to be responsive to elexacaftor/tezacaftor/ivacaftor can be accepted with a confirmation that these patients do not harbour two Class I mutations.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating the specific mutation considered to be responsive to elexacaftor/tezacaftor/ivacaftor as listed in the TGA approved PI - quote each of the: (i) specific mutation, and if the specific mutation is not listed in the TGA approved PI, confirmation that the patient does not harbour two Class I mutations, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have at least one mutation in the CFTR gene that is considered responsive to elexacaftor/tezacaftor/ivacaftor potentiation based on clinical and/or in vitro assay data; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be at least 6 years of age.</p> <p align=""justify"">For the purposes of this restriction, the list of mutations considered to be responsive to elexacaftor/tezacaftor/ivacaftor is defined in the TGA approved Product Information (PI). Mutations that are not listed in the TGA approved PI but considered to be responsive to elexacaftor/tezacaftor/ivacaftor can be accepted with a confirmation that these patients do not harbour two Class I mutations.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the pathology report substantiating the specific mutation considered to be responsive to elexacaftor/tezacaftor/ivacaftor as listed in the TGA approved PI - quote each of the: (i) specific mutation, and if the specific mutation is not listed in the TGA approved PI, confirmation that the patient does not harbour two Class I mutations, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(2) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17936_N","null","null","null","null","null","<p align=""justify"">Risk of myelofibrosis is defined in accordance with the Myelofibrosis International Prognostic Scoring System (IPSS) or the Dynamic International Prognostic Scoring System (DIPSS) or the Age-Adjusted DIPSS.</p>","Y","N","N","null","null","N","2015-12-01","N","4708"
"17938_17971_R","Continuing treatment","AUTHORITY_REQUIRED","17971","17938","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be aged between 2 and 11 years inclusive.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be aged between 2 and 11 years inclusive.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17939_N","null","null","null","null","null","<p align=""justify"">No increase in the maximum quantity may be authorised for the 15 mg and 20 mg dose strengths.</p>","Y","N","N","null","null","N","2015-12-01","N","4708"
"17941_18033_R","Initial treatment","AUTHORITY_REQUIRED","18033","17941","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; or</p> <p>The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Patient must require dosage reduction requiring a pack of 21 tablets; AND</p> <p>Must be treated by a medical practitioner; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; or</p> <p>The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Patient must require dosage reduction requiring a pack of 21 tablets; AND</p> <p>Must be treated by a medical practitioner; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17942_17978_R","Initial treatment as first-line epidermal growth factor receptor tyrosine kinase inhibitor therapy","AUTHORITY_REQUIRED","17978","17942","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment as first-line epidermal growth factor receptor tyrosine kinase inhibitor therapy</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); or</p> <p>Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material; AND</p> <p>Patient must not have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment as first-line epidermal growth factor receptor tyrosine kinase inhibitor therapy</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); or</p> <p>Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material; AND</p> <p>Patient must not have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17944_17864_R","Initial treatment","STREAMLINED","17864","17944","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic differentiated thyroid cancer</p><br/><p>Initial treatment</p><br/><p>The condition must be refractory to radioactive iodine; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have symptomatic progressive disease prior to treatment; or</p> <p>Patient must have progressive disease at critical sites with a high risk of morbidity or mortality where local control cannot be achieved by other measures; AND</p> <p>Patient must have thyroid stimulating hormone adequately suppressed; AND</p> <p>Patient must be one in whom surgery is inappropriate; AND</p> <p>Patient must not be a candidate for radiotherapy with curative intent; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Radioactive iodine refractory is defined as:</p><p align=""justify"">(i) a lesion without iodine uptake on a radioactive iodine (RAI) scan; or</p><p align=""justify"">(ii) having received a cumulative RAI dose of greater than or equal to 600 mCi; or</p><p align=""justify"">(iii) progression within 12 months of a single RAI treatment; or</p><p align=""justify"">(iv) progression after two RAI treatments administered within 12 months of each other.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic differentiated thyroid cancer</p><br/><p>Initial treatment</p><br/><p>The condition must be refractory to radioactive iodine; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have symptomatic progressive disease prior to treatment; or</p> <p>Patient must have progressive disease at critical sites with a high risk of morbidity or mortality where local control cannot be achieved by other measures; AND</p> <p>Patient must have thyroid stimulating hormone adequately suppressed; AND</p> <p>Patient must be one in whom surgery is inappropriate; AND</p> <p>Patient must not be a candidate for radiotherapy with curative intent; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Radioactive iodine refractory is defined as:</p><p align=""justify"">(i) a lesion without iodine uptake on a radioactive iodine (RAI) scan; or</p><p align=""justify"">(ii) having received a cumulative RAI dose of greater than or equal to 600 mCi; or</p><p align=""justify"">(iii) progression within 12 months of a single RAI treatment; or</p><p align=""justify"">(iv) progression after two RAI treatments administered within 12 months of each other.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17948_17915_R","Continuing treatment","AUTHORITY_REQUIRED","17915","17948","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection; AND</p> <p>Patient must not have experienced disease recurrence; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17952_17917_R","Continuing treatment","STREAMLINED","17917","17952","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition; AND</p> <p>Patient must have stable or responding disease; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition; AND</p> <p>Patient must have stable or responding disease; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17954_17811_R","null","RESTRICTED","17811","17954","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Carcinoma of the prostate</p><br/><p>The condition must be locally advanced (stage C); or</p> <p>The condition must be metastatic (stage D); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Carcinoma of the prostate</p><br/><p>The condition must be locally advanced (stage C); or</p> <p>The condition must be metastatic (stage D); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17955_18025_R","null","RESTRICTED","18025","17955","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p><br/><p>The condition must be visually proven; AND</p> <p>The treatment must be for the short-term (up to 6 months); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p><br/><p>The condition must be visually proven; AND</p> <p>The treatment must be for the short-term (up to 6 months); AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Only 1 course of not more than 6 months&apos; therapy will be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17957_17833_R","Continuing treatment - third-line therapy","STREAMLINED","17833","17957","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment - third-line therapy</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug as a third-line therapy for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment - third-line therapy</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug as a third-line therapy for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17959_17887_R","Continuing treatment","STREAMLINED","17887","17959","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Aggressive systemic mastocytosis with eosinophilia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND</p> <p>Patient must have achieved and maintained a complete haematological response; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A full blood examination report which demonstrates a complete haematological response and evidence that the disease has not progressed on imatinib therapy must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Aggressive systemic mastocytosis with eosinophilia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND</p> <p>Patient must have achieved and maintained a complete haematological response; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A full blood examination report which demonstrates a complete haematological response and evidence that the disease has not progressed on imatinib therapy must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17962_18030_R","Continuing treatment","AUTHORITY_REQUIRED","18030","17962","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17963_17991_R","First line drug treatment of this indication - as monotherapy","AUTHORITY_REQUIRED","17991","17963","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First line drug treatment of this indication - as monotherapy</p><br/><p>The condition must be untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; or</p> <p>Patient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First line drug treatment of this indication - as monotherapy</p><br/><p>The condition must be untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; or</p> <p>Patient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17965_17901_R","Initial treatment","STREAMLINED","17901","17965","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>Patient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug of either: (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient''s medical records; AND</p> <p>The condition must be untreated; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>Patient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug of either: (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient''s medical records; AND</p> <p>The condition must be untreated; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; or</p> <p>Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient''s medical records; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p> <p align=""justify""><i>A</i> prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk score can be calculated here: https://www.mdcalc.com/imdc-international-metastatic-rcc-database-consortium-risk-model-metastatic-renal-cell-carcinoma.</p><p align=""justify"">One point is assigned for each of:</p><p align=""justify"">(i) a time of diagnosis to systemic therapy of less than 1 year</p><p align=""justify"">(ii) a Karnofsky Performance Status of less than 80%</p><p align=""justify"">(iii) a haemoglobin less than the lower limit of normal</p><p align=""justify"">(iv) a corrected calcium level greater than the upper limit of normal</p><p align=""justify"">(v) a neutrophil count greater than the upper limit of normal</p><p align=""justify"">(vi) a platelet count greater than the upper limit of normal</p><p align=""justify"">Stated normal reference ranges may vary depending on the laboratory providing the measurement. &apos;Normal&apos; here refers to the individual laboratory&apos;s stated normal reference range.</p><p align=""justify"">Favourable IMDC risk is a score of 0.</p><p align=""justify"">Intermediate IMDC risk is a score of 1 to 2.</p><p align=""justify"">Poor IMDC risk is a score of 3 to 6.</p><p align=""justify"">Document any IMDC risk score assessment in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"17966_17933_R","Continuing treatment","AUTHORITY_REQUIRED","17933","17966","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged between 6 and 11 years inclusive.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and</p><p align=""justify"">(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must be aged between 6 and 11 years inclusive.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and</p><p align=""justify"">(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17972_17770_R","Continuing treatment","AUTHORITY_REQUIRED","17770","17972","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be 2 to 5 years of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be 2 to 5 years of age.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17974_17995_R","null","AUTHORITY_REQUIRED","17995","17974","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early breast cancer</p><br/><p>The treatment must be adjuvant to surgical resection; AND</p> <p>Patient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing this drug; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system); AND</p> <p>The treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 3 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression; AND</p> <p>The treatment must not be in combination with any of the following: (i) abemaciclib, (ii) olaparib, (iii) pembrolizumab; AND</p> <p>Patient must require dosage reduction requiring a pack of 21 tablets; AND</p> <p>Patient must be undergoing concurrent treatment with a non-steroidal aromatase inhibitor where this drug is being prescribed as a PBS benefit; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early breast cancer</p><br/><p>The treatment must be adjuvant to surgical resection; AND</p> <p>Patient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; or</p> <p>Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND</p> <p>The condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing this drug; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be hormone receptor positive; AND</p> <p>The condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system); AND</p> <p>The treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 3 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression; AND</p> <p>The treatment must not be in combination with any of the following: (i) abemaciclib, (ii) olaparib, (iii) pembrolizumab; AND</p> <p>Patient must require dosage reduction requiring a pack of 21 tablets; AND</p> <p>Patient must be undergoing concurrent treatment with a non-steroidal aromatase inhibitor where this drug is being prescribed as a PBS benefit; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Retain all pathology imaging and investigative test results in the patient&apos;s medical records.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17975_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form rizatriptan wafer 10 mg (as benzoate) and pharmaceutical benefits that have the form rizatriptan tablet (orally disintegrating) 10 mg (as benzoate) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-12-01","N","4708"
"17976_17977_R","Continuing treatment","AUTHORITY_REQUIRED","17977","17976","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Patient must require dosage reduction requiring a pack of 42 tablets; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Patient must require dosage reduction requiring a pack of 42 tablets; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17979_17794_R","Continuing treatment","STREAMLINED","17794","17979","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV renal cell carcinoma (RCC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV renal cell carcinoma (RCC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17980_17796_R","Continuing treatment","AUTHORITY_REQUIRED","17796","17980","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not be subsidised in combination with: (i) chemotherapy, (ii) a novel hormonal drug; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not be subsidised in combination with: (i) chemotherapy, (ii) a novel hormonal drug; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17982_17912_R","Continuation of first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets","AUTHORITY_REQUIRED","17912","17982","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets</p><br/><p>The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation); AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets</p><br/><p>The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation); AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17983_17805_R","Continuing treatment","AUTHORITY_REQUIRED","17805","17983","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17985_17923_R","null","RESTRICTED","17923","17985","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometrial cancer</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometrial cancer</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17986_18007_R","Continuing treatment","AUTHORITY_REQUIRED","18007","17986","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Waldenstrom macroglobulinaemia</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Waldenstrom macroglobulinaemia</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17987_18029_R","Continuing treatment","AUTHORITY_REQUIRED","18029","17987","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for Chronic lymphocytic leukaemia; or</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for Small lymphocytic leukaemia; AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for Chronic lymphocytic leukaemia; or</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for Small lymphocytic leukaemia; AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17988_18012_R","First continuing treatment","AUTHORITY_REQUIRED","18012","17988","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>First continuing treatment</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must demonstrated a peripheral blood level of BCR-ABL of less than 1% on the international scale in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">The first continuing application for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a major cytogenetic response [see Note explaining definitions of response]; or</p><p align=""justify"">(ii) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response].</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>First continuing treatment</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must demonstrated a peripheral blood level of BCR-ABL of less than 1% on the international scale in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">The first continuing application for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a major cytogenetic response [see Note explaining definitions of response]; or</p><p align=""justify"">(ii) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response].</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-02-01","Y","4708"
"17990_18014_R","Continuing treatment","AUTHORITY_REQUIRED","18014","17990","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory Acute Myeloid Leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not be for maintenance therapy post-transplant; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.</p><p align=""justify"">If abnormal blood counts suggest the potential for relapsed AML, following a response to gilteritinib, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.</p><p align=""justify"">Progressive disease is defined as the presence of any of the following:</p><p align=""justify"">(a) Leukaemic cells in the CSF; or</p><p align=""justify"">(b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; or</p><p align=""justify"">(c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; or</p><p align=""justify"">(d) Extramedullary leukaemia.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory Acute Myeloid Leukaemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not be for maintenance therapy post-transplant; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.</p><p align=""justify"">If abnormal blood counts suggest the potential for relapsed AML, following a response to gilteritinib, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.</p><p align=""justify"">Progressive disease is defined as the presence of any of the following:</p><p align=""justify"">(a) Leukaemic cells in the CSF; or</p><p align=""justify"">(b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; or</p><p align=""justify"">(c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; or</p><p align=""justify"">(d) Extramedullary leukaemia.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17992_17992_R","null","STREAMLINED","17992","17992","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intermediate or high risk of recurrence clear cell variant renal cell carcinoma (RCC)</p><br/><p>Patient must have: (i) pT2 with Grade 4 or sarcomatoid features; or (ii) pT3, with any grade without nodal involvement (N0) or distant metastases (M0); or (iii) pT4, any grade N0 and M0; or (iv) any pT, any grade with nodal involvement and M0; or (v) metastatic disease and has undergone complete resection of primary and metastatic lesions; AND</p> <p>The treatment must be in addition to complete surgical resection; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must not have previously been treated with systemic therapy for this condition, prior to commencing treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised anti-cancer therapy for this condition; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intermediate or high risk of recurrence clear cell variant renal cell carcinoma (RCC)</p><br/><p>Patient must have: (i) pT2 with Grade 4 or sarcomatoid features; or (ii) pT3, with any grade without nodal involvement (N0) or distant metastases (M0); or (iii) pT4, any grade N0 and M0; or (iv) any pT, any grade with nodal involvement and M0; or (v) metastatic disease and has undergone complete resection of primary and metastatic lesions; AND</p> <p>The treatment must be in addition to complete surgical resection; AND</p> <p>The treatment must commence within 12 weeks of complete resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must not have previously been treated with systemic therapy for this condition, prior to commencing treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised anti-cancer therapy for this condition; AND</p> <p>Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"17993_17967_R","Initial treatment","AUTHORITY_REQUIRED","17967","17993","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be aged between 6 and 11 years inclusive.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and</p><p align=""justify"">(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>Patient must be aged between 6 and 11 years inclusive.</p> <p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and</p><p align=""justify"">(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and</p><p align=""justify"">(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17994_17844_R","Initial treatment","AUTHORITY_REQUIRED","17844","17994","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis - one residual function (RF) mutation</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have at least one residual function (RF) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor with ivacaftor; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">For the purposes of this restriction, the list of mutations considered to be responsive to tezacaftor with ivacaftor is defined in the TGA approved product information.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.</p> <p align=""justify"">Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort;</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and</p><p align=""justify"">(3) details of the pathology report substantiating the patient having at least one RF mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient ; and</p><p align=""justify"">(4) CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis - one residual function (RF) mutation</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND</p> <p>Patient must have at least one residual function (RF) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor with ivacaftor; AND</p> <p>The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND</p> <p>The treatment must be given concomitantly with standard therapy for this condition; AND</p> <p>Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">For the purposes of this restriction, the list of mutations considered to be responsive to tezacaftor with ivacaftor is defined in the TGA approved product information.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.</p> <p align=""justify"">Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.</p> <p align=""justify"">Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:</p><p align=""justify"">Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John&apos;s wort;</p><p align=""justify"">Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;</p><p align=""justify"">Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.</p> <p align=""justify"">The authority application must be in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and</p><p align=""justify"">(3) details of the pathology report substantiating the patient having at least one RF mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient ; and</p><p align=""justify"">(4) CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.</p>","N","N","N","FULL","ALL","N","2026-02-01","Y","4708"
"17996_17853_R","Continuing treatment","AUTHORITY_REQUIRED","17853","17996","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND</p> <p>Patient must require dosage reduction requiring a pack of 21 tablets; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND</p> <p>Patient must require dosage reduction requiring a pack of 21 tablets; AND</p> <p>The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine; AND</p> <p>Patient must not be premenopausal.</p> <p align=""justify"">PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17997_18034_R","Initial treatment as second-line EGFR tyrosine kinase inhibitor therapy","AUTHORITY_REQUIRED","18034","17997","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment as second-line EGFR tyrosine kinase inhibitor therapy</p><br/><p>Patient must not have previously received this drug for this condition; AND</p> <p>The treatment must be as monotherapy; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The condition must have progressed on or after prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy as first line treatment for this condition; AND</p> <p>Patient must have evidence of EGFR T790M mutation in tumour material at the point of progression on or after first line EGFR TKI treatment; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment as second-line EGFR tyrosine kinase inhibitor therapy</p><br/><p>Patient must not have previously received this drug for this condition; AND</p> <p>The treatment must be as monotherapy; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The condition must have progressed on or after prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy as first line treatment for this condition; AND</p> <p>Patient must have evidence of EGFR T790M mutation in tumour material at the point of progression on or after first line EGFR TKI treatment; AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"17998_17999_R","Adjuvant therapy","AUTHORITY_REQUIRED","17999","17998","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IB, II or IIIA non-small cell lung cancer</p><br/><p>Adjuvant therapy</p><br/><p>Patient must be continuing existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS-subsidised supply of this drug, (ii) untreated with EGFR-TKI at the time this drug was initiated; AND</p> <p>The treatment must be for the purpose of adjuvant therapy following surgical resection; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be commenced within 26 weeks of surgery; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 3 years in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the word ''cancelled''; where (i)/(ii) has occurred; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IB, II or IIIA non-small cell lung cancer</p><br/><p>Adjuvant therapy</p><br/><p>Patient must be continuing existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS-subsidised supply of this drug, (ii) untreated with EGFR-TKI at the time this drug was initiated; AND</p> <p>The treatment must be for the purpose of adjuvant therapy following surgical resection; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be commenced within 26 weeks of surgery; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 3 years in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the word ''cancelled''; where (i)/(ii) has occurred; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18000_17793_R","Initial treatment","STREAMLINED","17793","18000","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not be suitable for transarterial chemoembolisation; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following: (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy, (iii) durvalumab/tremelimumab combination therapy; AND</p> <p>Must be treated by a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not be suitable for transarterial chemoembolisation; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have Child Pugh class A; AND</p> <p>The condition must be untreated with systemic therapy; or</p> <p>Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following: (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy, (iii) durvalumab/tremelimumab combination therapy; AND</p> <p>Must be treated by a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18001_18018_R","Continuing treatment","STREAMLINED","18018","18001","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18003_17947_R","Initial treatment","AUTHORITY_REQUIRED","17947","18003","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Must be treated by a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Must be treated by a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18005_17951_R","Continuing treatment","STREAMLINED","17951","18005","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition; AND</p> <p>Patient must have stable or responding disease; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable Stage III or Stage IV malignant melanoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition; AND</p> <p>Patient must have stable or responding disease; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18006_17918_R","null","STREAMLINED","17918","18006","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must not be premenopausal; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must not be premenopausal; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18009_17893_R","Continuing treatment","STREAMLINED","17893","18009","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Refractory follicular B-cell non-Hodgkin''s lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Refractory follicular B-cell non-Hodgkin''s lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18013_18039_R","Initial treatment","AUTHORITY_REQUIRED","18039","18013","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be expressing the T315I mutation; AND</p> <p>Patient must have failed treatment with chemotherapy, with or without another tyrosine kinase inhibitor; AND</p> <p>Patient must have failed allogeneic haemopoietic stem cell transplantation (where appropriate); AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Failure of treatment is defined as either:</p><p align=""justify"">1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy, with or without another tyrosine kinase inhibitor; </p><p align=""justify"">2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy, with or without another tyrosine kinase inhibitor;</p><p align=""justify"">3. Morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation.</p> <p/><p align=""justify"">Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">1. details of the proposed prescription; and</p><p align=""justify"">2. a completed Acute Lymphoblastic Leukaemia - ponatinib Initial PBS authority application form; and</p><p align=""justify"">3. a signed patient acknowledgement; and</p><p align=""justify"">4. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript; and evidence of the T315I mutation. The date of the relevant pathology report(s), which should be within the previous 6 months, need(s) to be provided.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be expressing the T315I mutation; AND</p> <p>Patient must have failed treatment with chemotherapy, with or without another tyrosine kinase inhibitor; AND</p> <p>Patient must have failed allogeneic haemopoietic stem cell transplantation (where appropriate); AND</p> <p>Must be treated by a medical practitioner.</p> <p align=""justify"">Failure of treatment is defined as either:</p><p align=""justify"">1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy, with or without another tyrosine kinase inhibitor; </p><p align=""justify"">2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy, with or without another tyrosine kinase inhibitor;</p><p align=""justify"">3. Morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation.</p> <p/><p align=""justify"">Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">1. details of the proposed prescription; and</p><p align=""justify"">2. a completed Acute Lymphoblastic Leukaemia - ponatinib Initial PBS authority application form; and</p><p align=""justify"">3. a signed patient acknowledgement; and</p><p align=""justify"">4. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript; and evidence of the T315I mutation. The date of the relevant pathology report(s), which should be within the previous 6 months, need(s) to be provided.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-02-01","Y","4708"
"18019_17911_R","Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation)","AUTHORITY_REQUIRED","17911","18019","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation)</p><br/><p>Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 24 months of combined non-PBS-subsidised and PBS-subsidised treatment for patients who are in complete response; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation)</p><br/><p>Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 24 months of combined non-PBS-subsidised and PBS-subsidised treatment for patients who are in complete response; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18020_17800_R","Continuation of first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets","AUTHORITY_REQUIRED","17800","18020","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets</p><br/><p>The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation); AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets</p><br/><p>The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation); AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18021_18022_R","Continuing treatment","AUTHORITY_REQUIRED","18022","18021","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18023_17809_R","null","RESTRICTED","17809","18023","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate</p><br/><p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18024_17953_R","null","AUTHORITY_REQUIRED","17953","18024","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>The treatment must not be used in combination with chemotherapy; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND</p> <p>Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); or</p> <p>Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; or</p> <p>Patient must have been receiving PBS-subsidised treatment with abiraterone or abiraterone plus methylprednisolone for castration resistant metastatic prostate cancer prior to being associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Castration resistant metastatic carcinoma of the prostate</p><br/><p>The treatment must not be used in combination with chemotherapy; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND</p> <p>Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); or</p> <p>Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; or</p> <p>Patient must have been receiving PBS-subsidised treatment with abiraterone or abiraterone plus methylprednisolone for castration resistant metastatic prostate cancer prior to being associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18026_17919_R","null","RESTRICTED","17919","18026","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) breast cancer</p><br/><p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>Patient must be receiving PBS-subsidised everolimus concomitantly for this condition; AND</p> <p>Patient must not be pre-menopausal; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) breast cancer</p><br/><p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>Patient must be receiving PBS-subsidised everolimus concomitantly for this condition; AND</p> <p>Patient must not be pre-menopausal; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18027_17927_R","First line drug treatment of this indication","AUTHORITY_REQUIRED","17927","18027","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First line drug treatment of this indication</p><br/><p>The condition must be untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; or</p> <p>Patient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First line drug treatment of this indication</p><br/><p>The condition must be untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; or</p> <p>Patient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18028_17961_R","Initial treatment","AUTHORITY_REQUIRED","17961","18028","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Waldenstrom macroglobulinaemia</p><br/><p>Initial treatment</p><br/><p>The condition must have relapsed or be refractory to at least one prior chemo-immunotherapy; or</p> <p>Patient must be unsuitable for treatment with chemo-immunotherapy, defined by a Cumulative Illness Rating Scale of 6 or greater, if untreated (i.e. treatment-naive) for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>Patient must be untreated with a Bruton''s tyrosine kinase inhibitor for this condition; or</p> <p>Patient must have developed intolerance to another Bruton''s tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this condition; AND</p> <p>Must be treated by a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Waldenstrom macroglobulinaemia</p><br/><p>Initial treatment</p><br/><p>The condition must have relapsed or be refractory to at least one prior chemo-immunotherapy; or</p> <p>Patient must be unsuitable for treatment with chemo-immunotherapy, defined by a Cumulative Illness Rating Scale of 6 or greater, if untreated (i.e. treatment-naive) for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND</p> <p>Patient must be untreated with a Bruton''s tyrosine kinase inhibitor for this condition; or</p> <p>Patient must have developed intolerance to another Bruton''s tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this condition; AND</p> <p>Must be treated by a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18035_17913_R","Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets","AUTHORITY_REQUIRED","17913","18035","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets</p><br/><p>Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer</p><br/><p>Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets</p><br/><p>Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18036_17956_R","null","RESTRICTED","17956","18036","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anticipated premature ovarian failure</p><br/><p>Patient must be receiving treatment with an alkylating agent for a malignancy or an autoimmune disorder that has a high risk of causing premature ovarian failure; AND</p> <p>Patient must not receive more than 6 months'' of treatment for this condition in a lifetime; AND</p> <p>Patient must be pre-menopausal; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anticipated premature ovarian failure</p><br/><p>Patient must be receiving treatment with an alkylating agent for a malignancy or an autoimmune disorder that has a high risk of causing premature ovarian failure; AND</p> <p>Patient must not receive more than 6 months'' of treatment for this condition in a lifetime; AND</p> <p>Patient must be pre-menopausal; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18038_17895_R","Continuing treatment - second-line therapy","STREAMLINED","17895","18038","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment - second-line therapy</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug as a second-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with dasatinib for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing treatment - second-line therapy</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug as a second-line therapy for this condition; or</p> <p>Patient must have experienced intolerance, not a failure to respond, to PBS-subsidised second-line treatment with dasatinib for this condition; AND</p> <p>Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or</p> <p>Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2026-02-01","N","4708"
"18048_18105_R","Continuing treatment (Cycles 2-12)","AUTHORITY_REQUIRED","18105","18048","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Continuing treatment (Cycles 2-12)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given in combination with gemcitabine and oxaliplatin for the first 8 cycles unless the patient has a contraindication/toxicity necessitating discontinuation of one or both chemotherapy components; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 12 cycles of this drug for this indication, regardless of whether treatment was non-PBS or PBS-subsidised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Continuing treatment (Cycles 2-12)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be given in combination with gemcitabine and oxaliplatin for the first 8 cycles unless the patient has a contraindication/toxicity necessitating discontinuation of one or both chemotherapy components; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 12 cycles of this drug for this indication, regardless of whether treatment was non-PBS or PBS-subsidised.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18050_18109_R","Initial treatment - Initial 1, Face, hand, foot (new patient)","AUTHORITY_REQUIRED","18109","18050","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-03-01","Y","4708"
"18051_18065_R","Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18065","18051","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-03-01","Y","4708"
"18052_18070_R","null","STREAMLINED","18070","18052","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Immunotherapy sensitive advanced or metastatic cancer</p><br/><p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for the condition which treatment was commenced for.</p> <p align=""justify"">Patients must only receive a maximum of 240 mg every two weeks, 360 mg every three weeks, or 480 mg every four weeks under a weight based or flat dosing regimen.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Immunotherapy sensitive advanced or metastatic cancer</p><br/><p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for the condition which treatment was commenced for.</p> <p align=""justify"">Patients must only receive a maximum of 240 mg every two weeks, 360 mg every three weeks, or 480 mg every four weeks under a weight based or flat dosing regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18054_18114_R","null","STREAMLINED","18114","18054","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition; AND</p> <p>Must be treated by a respiratory physician; or</p> <p>Must be treated by a paediatrician.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition; AND</p> <p>Must be treated by a respiratory physician; or</p> <p>Must be treated by a paediatrician.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18059_18059_R","null","STREAMLINED","18059","18059","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic sialorrhea</p><br/><p>Patient must be initiating treatment with a Drooling Severity and Frequency Scale (DSFS) score of at least 6; or</p> <p>Patient must be continuing treatment with improvement in the DSFS score of at least 1 point from baseline as assessed by the treating clinician; AND</p> <p>Patient must have Parkinson''s disease; or</p> <p>Patient must have atypical Parkinson''s; or</p> <p>Patient must have traumatic brain injury; or</p> <p>Patient must have chronic sialorrhea following an acute event; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a geriatrician; or</p> <p>Must be treated by an otolaryngologist surgeon; or</p> <p>Must be treated by a plastic surgeon.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic sialorrhea</p><br/><p>Patient must be initiating treatment with a Drooling Severity and Frequency Scale (DSFS) score of at least 6; or</p> <p>Patient must be continuing treatment with improvement in the DSFS score of at least 1 point from baseline as assessed by the treating clinician; AND</p> <p>Patient must have Parkinson''s disease; or</p> <p>Patient must have atypical Parkinson''s; or</p> <p>Patient must have traumatic brain injury; or</p> <p>Patient must have chronic sialorrhea following an acute event; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a geriatrician; or</p> <p>Must be treated by an otolaryngologist surgeon; or</p> <p>Must be treated by a plastic surgeon.</p> <p align=""justify"">For the purposes of administering this restriction, the Drooling Score is defined as the sum of the Severity and Frequency sub-scores.</p><p align=""justify"">Drooling Severity Scale:</p><ol><li>Never drools, dry;</li><li><p align=""justify"">Mild-drooling, only lips wet;</p></li><li><p align=""justify"">Moderate - drool reaches the lips and chin;</p></li><li><p align=""justify"">Severe - drool drips off chin and onto clothing;</p></li><li><p align=""justify"">Profuse - drooling off the body and onto objects (e.g. furniture, books).</p></li></ol><p align=""justify"">Drooling Frequency Scale:</p><ol><li><p align=""justify"">No drooling;</p></li><li><p align=""justify"">Occasionally drools;</p></li><li><p align=""justify"">Frequently drools;</p></li><li><p align=""justify"">Constant drooling.</p></li></ol>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18060_13406_R","Continuing treatment","STREAMLINED","13406","18060","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to age-related macular degeneration (AMD); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to age-related macular degeneration (AMD); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18062_18107_R","Initial treatment (Cycle 1, Day 8)","AUTHORITY_REQUIRED","18107","18062","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Initial treatment (Cycle 1, Day 8)</p><br/><p>Patient must be currently unable to receive treatment with CAR-T cell therapy for this condition; AND</p> <p>Patient must be unsuitable for stem cell transplant; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have received or intend to receive a single pre-treatment dose of obinutuzumab for this indication; AND</p> <p>The treatment must be given in combination with gemcitabine and oxaliplatin for the first 8 cycles unless the patient has a contraindication/toxicity necessitating discontinuation of one or both chemotherapy components.</p> <p align=""justify"">Definition of patients unable to receive treatment with CAR-T cell therapy for this condition include geographical, psychosocial, clinical ineligibility or urgency.</p> <p align=""justify"">Glofitamab should be administered as an intravenous infusion according to the dose step-up schedule in Cycle 1 (2.5 mg on Day 8 and 10 mg on Day 15) leading to the recommended dosage of 30 mg on Day 1 of Cycles 2-12. Refer to the TGA approved Product Information.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Initial treatment (Cycle 1, Day 8)</p><br/><p>Patient must be currently unable to receive treatment with CAR-T cell therapy for this condition; AND</p> <p>Patient must be unsuitable for stem cell transplant; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have received or intend to receive a single pre-treatment dose of obinutuzumab for this indication; AND</p> <p>The treatment must be given in combination with gemcitabine and oxaliplatin for the first 8 cycles unless the patient has a contraindication/toxicity necessitating discontinuation of one or both chemotherapy components.</p> <p align=""justify"">Definition of patients unable to receive treatment with CAR-T cell therapy for this condition include geographical, psychosocial, clinical ineligibility or urgency.</p> <p align=""justify"">Glofitamab should be administered as an intravenous infusion according to the dose step-up schedule in Cycle 1 (2.5 mg on Day 8 and 10 mg on Day 15) leading to the recommended dosage of 30 mg on Day 1 of Cycles 2-12. Refer to the TGA approved Product Information.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18063_18084_R","Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18084","18063","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-03-01","Y","4708"
"18068_18116_R","Continuing treatment, Whole body","AUTHORITY_REQUIRED","18116","18068","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-03-01","Y","4708"
"18071_18071_R","null","STREAMLINED","18071","18071","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Immunotherapy sensitive advanced or metastatic cancer</p><br/><p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for the condition which treatment was commenced for.</p> <p align=""justify"">The stated maximum amount in this listing is 360 mg however alternative dosing schedules may be prescribed in a quantity up to this amount, but need not be this amount for every cancer type.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Immunotherapy sensitive advanced or metastatic cancer</p><br/><p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for the condition which treatment was commenced for.</p> <p align=""justify"">The stated maximum amount in this listing is 360 mg however alternative dosing schedules may be prescribed in a quantity up to this amount, but need not be this amount for every cancer type.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18072_18087_R","Initial treatment","AUTHORITY_REQUIRED","18087","18072","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)</p><br/><p>Initial treatment</p><br/><p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must be 18 years of age or under.</p> <p align=""justify"">Defined signs and symptoms of type I SMA are:</p><p align=""justify"">i) Onset before 6 months of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Defined signs and symptoms of type II SMA are:</p><p align=""justify"">i) Onset between 6 and 18 months; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Weakness in trunk righting/derotation; or</p><p align=""justify"">v) Hypotonia; or</p><p align=""justify"">vi) Absence of deep tendon reflexes; or</p><p align=""justify"">vii) Failure to gain weight appropriate for age; or</p><p align=""justify"">viii) Any active chronic neurogenic changes; or</p><p align=""justify"">ix) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Defined signs and symptoms of type IIIa SMA are:</p><p align=""justify"">i) Onset between 18 months and 3 years of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) specification of SMA type (I, II or IIIa); and</p><p align=""justify"">(ii) sign(s) and symptom(s) that the patient has experienced; and</p><p align=""justify"">(iii) patient&apos;s age at the onset of sign(s) and symptom(s).</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)</p><br/><p>Initial treatment</p><br/><p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must be 18 years of age or under.</p> <p align=""justify"">Defined signs and symptoms of type I SMA are:</p><p align=""justify"">i) Onset before 6 months of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Defined signs and symptoms of type II SMA are:</p><p align=""justify"">i) Onset between 6 and 18 months; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Weakness in trunk righting/derotation; or</p><p align=""justify"">v) Hypotonia; or</p><p align=""justify"">vi) Absence of deep tendon reflexes; or</p><p align=""justify"">vii) Failure to gain weight appropriate for age; or</p><p align=""justify"">viii) Any active chronic neurogenic changes; or</p><p align=""justify"">ix) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Defined signs and symptoms of type IIIa SMA are:</p><p align=""justify"">i) Onset between 18 months and 3 years of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) specification of SMA type (I, II or IIIa); and</p><p align=""justify"">(ii) sign(s) and symptom(s) that the patient has experienced; and</p><p align=""justify"">(iii) patient&apos;s age at the onset of sign(s) and symptom(s).</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","N","N","N","FULL","ALL","N","2026-03-01","Y","4708"
"18074_18110_R","Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 1 or 2 copies of the SMN2 gene - Loading doses","AUTHORITY_REQUIRED","18110","18074","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 1 or 2 copies of the SMN2 gene - Loading doses</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>The condition must be pre-symptomatic SMA, with genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must be aged under 36 months prior to commencing treatment.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) confirmation of genetic diagnosis of SMA; and</p><p align=""justify"">(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 1 or 2 copies of the SMN2 gene - Loading doses</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>The condition must be pre-symptomatic SMA, with genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must be aged under 36 months prior to commencing treatment.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) confirmation of genetic diagnosis of SMA; and</p><p align=""justify"">(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)</p> <p align=""justify"">An outcome on the authority application is not immediate, but will follow in due course. Electronic upload is encouraged to reduce processing time.</p>","N","N","N","FULL","ALL","N","2026-03-01","Y","4708"
"18075_18076_R","Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene - Loading doses","AUTHORITY_REQUIRED","18076","18075","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene - Loading doses</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>The condition must be pre-symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must be aged under 36 months prior to commencing treatment.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) confirmation of genetic diagnosis of SMA; and</p><p align=""justify"">(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene - Loading doses</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>The condition must be pre-symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must be aged under 36 months prior to commencing treatment.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) confirmation of genetic diagnosis of SMA; and</p><p align=""justify"">(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)</p> <p align=""justify"">An outcome on the authority application is not immediate, but will follow in due course. Electronic upload is encouraged to reduce processing time.</p>","N","N","N","FULL","ALL","N","2026-03-01","Y","4708"
"18082_18082_R","Pre-treatment prior to initiation of glofitamab","STREAMLINED","18082","18082","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Pre-treatment prior to initiation of glofitamab</p><br/><p>Patient must be eligible to receive treatment under the PBS listing criteria for glofitamab.</p> <p align=""justify"">Patient is intended to receive a single dose of Obinutuzumab 1000 mg 7 days prior to initiating glofitamab treatment (Cycle 1, Day 1).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Pre-treatment prior to initiation of glofitamab</p><br/><p>Patient must be eligible to receive treatment under the PBS listing criteria for glofitamab.</p> <p align=""justify"">Patient is intended to receive a single dose of Obinutuzumab 1000 mg 7 days prior to initiating glofitamab treatment (Cycle 1, Day 1).</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18085_18064_R","Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18064","18085","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-03-01","Y","4708"
"18086_18066_R","Continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","18066","18086","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-03-01","Y","4708"
"18088_18118_R","Initial treatment with this drug of pre-symptomatic spinal muscular atrophy (SMA)","AUTHORITY_REQUIRED","18118","18088","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Initial treatment with this drug of pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>The condition must have genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; AND</p> <p>The condition must be pre-symptomatic; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must be aged under 36 months prior to commencing treatment.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) confirmation of genetic diagnosis of SMA; and</p><p align=""justify"">(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)</p> <p align=""justify"">The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant &apos;Note&apos; attached to this listing.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Initial treatment with this drug of pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>The condition must have genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; AND</p> <p>The condition must be pre-symptomatic; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must be aged under 36 months prior to commencing treatment.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) confirmation of genetic diagnosis of SMA; and</p><p align=""justify"">(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)</p> <p align=""justify"">The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant &apos;Note&apos; attached to this listing.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","N","N","N","FULL","ALL","N","2026-03-01","Y","4708"
"18089_18090_R","Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene","AUTHORITY_REQUIRED","18090","18089","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>The condition must be pre-symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must be aged under 36 months prior to commencing treatment.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) confirmation of genetic diagnosis of SMA; and</p><p align=""justify"">(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)</p> <p align=""justify"">The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant &apos;Note&apos; attached to this listing.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>The condition must be pre-symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must be aged under 36 months prior to commencing treatment.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) confirmation of genetic diagnosis of SMA; and</p><p align=""justify"">(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)</p> <p align=""justify"">The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant &apos;Note&apos; attached to this listing.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","N","N","N","FULL","ALL","N","2026-03-01","Y","4708"
"18091_18073_R","Initial treatment - Loading doses","AUTHORITY_REQUIRED","18073","18091","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)</p><br/><p>Initial treatment - Loading doses</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must be 18 years of age or under.</p> <p align=""justify"">Defined signs and symptoms of type I SMA are:</p><p align=""justify"">i) Onset before 6 months of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Defined signs and symptoms of type II SMA are:</p><p align=""justify"">i) Onset between 6 and 18 months; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Weakness in trunk righting/derotation; or</p><p align=""justify"">v) Hypotonia; or</p><p align=""justify"">vi) Absence of deep tendon reflexes; or</p><p align=""justify"">vii) Failure to gain weight appropriate for age; or</p><p align=""justify"">viii) Any active chronic neurogenic changes; or</p><p align=""justify"">ix) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Defined signs and symptoms of type IIIa SMA are:</p><p align=""justify"">i) Onset between 18 months and 3 years of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) specification of SMA type (I, II or IIIa); and</p><p align=""justify"">(ii) sign(s) and symptom(s) that the patient has experienced; and</p><p align=""justify"">(iii) patient&apos;s age at the onset of sign(s) and symptom(s).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)</p><br/><p>Initial treatment - Loading doses</p><br/><p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must be 18 years of age or under.</p> <p align=""justify"">Defined signs and symptoms of type I SMA are:</p><p align=""justify"">i) Onset before 6 months of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Defined signs and symptoms of type II SMA are:</p><p align=""justify"">i) Onset between 6 and 18 months; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Weakness in trunk righting/derotation; or</p><p align=""justify"">v) Hypotonia; or</p><p align=""justify"">vi) Absence of deep tendon reflexes; or</p><p align=""justify"">vii) Failure to gain weight appropriate for age; or</p><p align=""justify"">viii) Any active chronic neurogenic changes; or</p><p align=""justify"">ix) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Defined signs and symptoms of type IIIa SMA are:</p><p align=""justify"">i) Onset between 18 months and 3 years of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) specification of SMA type (I, II or IIIa); and</p><p align=""justify"">(ii) sign(s) and symptom(s) that the patient has experienced; and</p><p align=""justify"">(iii) patient&apos;s age at the onset of sign(s) and symptom(s).</p> <p align=""justify"">An outcome on the authority application is not immediate, but will follow in due course. Electronic upload is encouraged to reduce processing time.</p>","N","N","N","FULL","ALL","N","2026-03-01","Y","4708"
"18092_18101_R","Changing the prescribed therapy","AUTHORITY_REQUIRED","18101","18092","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Changing the prescribed therapy</p><br/><p>Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated prior to the patient''s 19th birthday for SMA type IIIB/IIIC; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The prescriber has given consideration to whether a &apos;wash out&apos; period is recommended or not prior to changing the prescribed therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Changing the prescribed therapy</p><br/><p>Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated prior to the patient''s 19th birthday for SMA type IIIB/IIIC; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The prescriber has given consideration to whether a &apos;wash out&apos; period is recommended or not prior to changing the prescribed therapy.</p> <p align=""justify"">Subsequent changes in the prescribed drug where applicable are to occur under the &apos;Continuing treatment&apos; phase listing of the drug that therapy is changing to.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18093_18077_R","Initial PBS-subsidised treatment in a child","AUTHORITY_REQUIRED","18077","18093","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Initial PBS-subsidised treatment in a child</p><br/><p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must be of an age that is prior to their 19th birthday at the time of this authority application; AND</p> <p>Patient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rd birthday, but before their 19th birthday (SMA type IIIB/IIIC); AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Patient must be undergoing initial PBS-subsidised treatment for untreated disease - prescribe up to 3 repeat prescriptions to enable dosing occurring at days: 0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); or</p> <p>Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access) - prescribe zero repeat prescriptions where loading doses are complete; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:</p><p align=""justify"">(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,</p><p align=""justify"">(ii) Proximal weakness,</p><p align=""justify"">(iii) Hypotonia,</p><p align=""justify"">(iv) Absence of deep tendon reflexes,</p><p align=""justify"">(v) Any active denervation or chronic neurogenic changes found on electromyography,</p><p align=""justify"">(vi) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">In this authority application, confirm:</p><p align=""justify"">(1) the patient&apos;s medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy,</p><p align=""justify"">(2) which of the above (i to vi) (at least 1) were present after their 3<sup>rd</sup> birthday, but before their 19<sup>th</sup> birthday,</p><p align=""justify"">(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Initial PBS-subsidised treatment in a child</p><br/><p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must be of an age that is prior to their 19th birthday at the time of this authority application; AND</p> <p>Patient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rd birthday, but before their 19th birthday (SMA type IIIB/IIIC); AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Patient must be undergoing initial PBS-subsidised treatment for untreated disease - prescribe up to 3 repeat prescriptions to enable dosing occurring at days: 0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); or</p> <p>Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access) - prescribe zero repeat prescriptions where loading doses are complete; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:</p><p align=""justify"">(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,</p><p align=""justify"">(ii) Proximal weakness,</p><p align=""justify"">(iii) Hypotonia,</p><p align=""justify"">(iv) Absence of deep tendon reflexes,</p><p align=""justify"">(v) Any active denervation or chronic neurogenic changes found on electromyography,</p><p align=""justify"">(vi) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">In this authority application, confirm:</p><p align=""justify"">(1) the patient&apos;s medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy,</p><p align=""justify"">(2) which of the above (i to vi) (at least 1) were present after their 3<sup>rd</sup> birthday, but before their 19<sup>th</sup> birthday,</p><p align=""justify"">(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.</p> <p align=""justify"">Recognised hospitals in the management of SMA are Queensland Children&apos;s Hospital (Brisbane), Royal Children&apos;s Hospital Melbourne, Monash Children&apos;s Hospital (Melbourne), John Hunter Hospital (Newcastle), Sydney Children&apos;s Hospital Randwick, Children&apos;s Hospital at Westmead, Adelaide Women and Children&apos;s Hospital and Perth Children&apos;s Hospital.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p> <p align=""justify"">An outcome on the authority application is not immediate, but will follow in due course. Electronic upload is encouraged to reduce processing time.</p>","N","N","Y","FULL","ALL","N","2026-03-01","Y","4708"
"18095_18121_R","null","STREAMLINED","18121","18095","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18096_18125_R","null","RESTRICTED","18125","18096","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Patient must be experiencing fluctuations in motor function due to end-of-dose effect; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND</p> <p>Patient must be experiencing fluctuations in motor function due to end-of-dose effect; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18099_13402_R","Continuing treatment","STREAMLINED","13402","18099","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetic macular oedema (DMO)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetic macular oedema (DMO)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be in combination with laser photocoagulation; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18100_18069_R","null","STREAMLINED","18069","18100","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage III melanoma</p><br/><p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must be in addition to complete surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>The treatment must be in combination with PBS-subsidised treatment with nivolumab.</p> <p align=""justify"">Prescribed amounts must be consistent with the treatment protocol used for an individual patient.</p> <p align=""justify"">When ipilimumab is initially prescribed as a 3-weekly dosing regimen, patients must only receive a maximum of 80 mg every 3 weeks for 2 cycles (i.e., 1 repeat), in combination with nivolumab.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage III melanoma</p><br/><p>Patient must not have received prior PBS-subsidised treatment for this condition; AND</p> <p>The treatment must be in addition to complete surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>The treatment must be in combination with PBS-subsidised treatment with nivolumab.</p> <p align=""justify"">Prescribed amounts must be consistent with the treatment protocol used for an individual patient.</p> <p align=""justify"">When ipilimumab is initially prescribed as a 3-weekly dosing regimen, patients must only receive a maximum of 80 mg every 3 weeks for 2 cycles (i.e., 1 repeat), in combination with nivolumab.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18102_18094_R","Initial PBS-subsidised treatment in an adult who did not initiate PBS subsidy during childhood","AUTHORITY_REQUIRED","18094","18102","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Initial PBS-subsidised treatment in an adult who did not initiate PBS subsidy during childhood</p><br/><p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; AND</p> <p>Patient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19th birthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS-subsidised); AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing initial PBS-subsidised treatment for untreated disease - prescribe up to 3 repeat prescriptions to enable dosing occurring at days: 0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); or</p> <p>Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access) - prescribe zero repeat prescriptions where loading doses are complete; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:</p><p align=""justify"">(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,</p><p align=""justify"">(ii) Proximal weakness,</p><p align=""justify"">(iii) Hypotonia,</p><p align=""justify"">(iv) Absence of deep tendon reflexes,</p><p align=""justify"">(v) Failure to gain weight appropriate for age,</p><p align=""justify"">(vi) Any active denervation or chronic neurogenic changes found on electromyography,</p><p align=""justify"">(vii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">In this authority application, confirm:</p><p align=""justify"">(1) the patient&apos;s medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy,</p><p align=""justify"">(2) which of the above (i to vii) (at least 1) were present during childhood,</p><p align=""justify"">(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Initial PBS-subsidised treatment in an adult who did not initiate PBS subsidy during childhood</p><br/><p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; AND</p> <p>Patient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19th birthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS-subsidised); AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing initial PBS-subsidised treatment for untreated disease - prescribe up to 3 repeat prescriptions to enable dosing occurring at days: 0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); or</p> <p>Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access) - prescribe zero repeat prescriptions where loading doses are complete; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:</p><p align=""justify"">(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,</p><p align=""justify"">(ii) Proximal weakness,</p><p align=""justify"">(iii) Hypotonia,</p><p align=""justify"">(iv) Absence of deep tendon reflexes,</p><p align=""justify"">(v) Failure to gain weight appropriate for age,</p><p align=""justify"">(vi) Any active denervation or chronic neurogenic changes found on electromyography,</p><p align=""justify"">(vii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">In this authority application, confirm:</p><p align=""justify"">(1) the patient&apos;s medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy,</p><p align=""justify"">(2) which of the above (i to vii) (at least 1) were present during childhood,</p><p align=""justify"">(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p> <p align=""justify"">An outcome on the authority application is not immediate, but will follow in due course. Electronic upload is encouraged to reduce processing time.</p>","N","N","Y","FULL","ALL","N","2026-03-01","Y","4708"
"18104_18061_R","Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements","AUTHORITY_REQUIRED","18061","18104","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS condition prior to 1 March 2026; AND</p> <p>Patient must have been unable to receive treatment with CAR-T cell therapy prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must have been unsuitable for stem cell transplant prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must have had a WHO performance status of 2 or less prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be given in combination with gemcitabine and oxaliplatin for the first 8 cycles unless the patient has a contraindication/toxicity necessitating discontinuation of one or both chemotherapy components; AND</p> <p>The treatment must not exceed a total of 12 cycles of this drug for this indication, regardless of whether treatment was non-PBS or PBS-subsidised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS condition prior to 1 March 2026; AND</p> <p>Patient must have been unable to receive treatment with CAR-T cell therapy prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must have been unsuitable for stem cell transplant prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must have had a WHO performance status of 2 or less prior to commencing treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must be given in combination with gemcitabine and oxaliplatin for the first 8 cycles unless the patient has a contraindication/toxicity necessitating discontinuation of one or both chemotherapy components; AND</p> <p>The treatment must not exceed a total of 12 cycles of this drug for this indication, regardless of whether treatment was non-PBS or PBS-subsidised.</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18108_18067_R","Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18067","18108","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-03-01","Y","4708"
"18111_18078_R","Changing the prescribed therapy","AUTHORITY_REQUIRED","18078","18111","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Changing the prescribed therapy</p><br/><p>Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated after the patient''s 19th birthday; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The prescriber has given consideration to whether a &apos;wash out&apos; period is recommended or not prior to changing the prescribed therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Changing the prescribed therapy</p><br/><p>Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated after the patient''s 19th birthday; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The prescriber has given consideration to whether a &apos;wash out&apos; period is recommended or not prior to changing the prescribed therapy.</p> <p align=""justify"">Subsequent changes in the prescribed drug where applicable are to occur under the &apos;Continuing treatment&apos; phase listing of the drug that therapy is changing to.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18112_18079_R","null","STREAMLINED","18079","18112","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be symptomatic with NYHA classes II or III; AND</p> <p>Patient must be in sinus rhythm; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 35%; AND</p> <p>Patient must have a resting heart rate at or above 77 bpm at the time ivabradine treatment is initiated; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include the maximum tolerated dose of a beta-blocker, unless contraindicated or not tolerated.</p> <p>Resting heart rate should be measured by ECG or echocardiography, after 5 minutes rest.</p> <p>The ECG or echocardiography, result must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be symptomatic with NYHA classes II or III; AND</p> <p>Patient must be in sinus rhythm; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 35%; AND</p> <p>Patient must have a resting heart rate at or above 77 bpm at the time ivabradine treatment is initiated; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include the maximum tolerated dose of a beta-blocker, unless contraindicated or not tolerated.</p> <p>Resting heart rate should be measured by ECG or echocardiography, after 5 minutes rest.</p> <p>The ECG or echocardiography, result must be documented in the patient&apos;s medical records when treatment is initiated.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18117_18083_R","Initial treatment - Initial 1, Whole body (new patient)","AUTHORITY_REQUIRED","18083","18117","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-03-01","Y","4708"
"18119_18047_R","null","STREAMLINED","18047","18119","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic sialorrhea</p><br/><p>Patient must be initiating treatment with a Drooling Severity and Frequency Scale (DSFS) score of at least 6; or</p> <p>Patient must be continuing treatment with improvement in the DSFS score of at least 1 point from baseline as assessed by the treating clinician; AND</p> <p>Patient must have cerebral palsy; or</p> <p>Patient must have traumatic brain injury; or</p> <p>Patient must have developmental disorder; AND</p> <p>Patient must be aged from 2 to 17 years inclusive; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by an otolaryngologist surgeon; or</p> <p>Must be treated by a plastic surgeon.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic sialorrhea</p><br/><p>Patient must be initiating treatment with a Drooling Severity and Frequency Scale (DSFS) score of at least 6; or</p> <p>Patient must be continuing treatment with improvement in the DSFS score of at least 1 point from baseline as assessed by the treating clinician; AND</p> <p>Patient must have cerebral palsy; or</p> <p>Patient must have traumatic brain injury; or</p> <p>Patient must have developmental disorder; AND</p> <p>Patient must be aged from 2 to 17 years inclusive; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by an otolaryngologist surgeon; or</p> <p>Must be treated by a plastic surgeon.</p> <p align=""justify"">For the purposes of administering this restriction, the Drooling Score is defined as the sum of the Severity and Frequency sub-scores.</p><p align=""justify"">Drooling Severity Scale:</p><ol><li>Never drools, dry;</li><li><p align=""justify"">Mild-drooling, only lips wet;</p></li><li><p align=""justify"">Moderate - drool reaches the lips and chin;</p></li><li><p align=""justify"">Severe - drool drips off chin and onto clothing;</p></li><li><p align=""justify"">Profuse - drooling off the body and onto objects (e.g. furniture, books).</p></li></ol><p align=""justify"">Drooling Frequency Scale:</p><ol><li><p align=""justify"">No drooling;</p></li><li><p align=""justify"">Occasionally drools;</p></li><li><p align=""justify"">Frequently drools;</p></li><li><p align=""justify"">Constant drooling.</p></li></ol>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18120_18053_R","Initial treatment occurring after onasemnogene abeparvovec therapy in a patient with one of: (i) Type 1 SMA, or, (ii) pre-symptomatic SMA","AUTHORITY_REQUIRED","18053","18120","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Initial treatment occurring after onasemnogene abeparvovec therapy in a patient with one of: (i) Type 1 SMA, or, (ii) pre-symptomatic SMA</p><br/><p>Patient must have experienced a regression in a developmental state listed below (see ''Definition'') despite treatment with gene therapy - confirm that this: (i) not due to an acute concomitant illness; (ii) not due to non-compliance to best-supportive care, (iii) apparent for at least 3 months, (iv) verified by another clinician in the treatment team - state the full name of this clinician plus their profession (e.g. medical practitioner, nurse, physiotherapist; this is not an exhaustive list of examples); AND</p> <p>The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Patient must be undergoing treatment under this Treatment phase listing once only - for continuing treatment beyond this authority application, refer to the drug''s relevant ''Continuing treatment'' listing for the patient''s SMA type; AND</p> <p>Patient must have a prior authority approval for any drug PBS-listed for symptomatic Type 1 SMA, with at least one approval having been for gene therapy; or</p> <p>Patient must have a prior authority approval for any drug PBS-listed for pre-symptomatic SMA, with at least one approval having been for gene therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.</p><p align=""justify"">Confirm that a previous PBS authority application has been approved for one of the following:</p><p align=""justify"">(i) Symptomatic Type 1 SMA; or</p><p align=""justify"">(ii) Pre-symptomatic SMA treated with nusinersen.</p> <p align=""justify"">Definition:</p><p align=""justify"">Various childhood developmental states (1 to 9) are listed below, some followed by further observations (a up to d). Where at least one developmental state/observation is no longer present, that developmental state has regressed.</p><p align=""justify"">0. Absence of developmental states (1 to 9) listed below:</p><p align=""justify"">1. Rolls from side to side on back;</p><p align=""justify"">2. Child holds head erect for at least 3 seconds unsupported;</p><p align=""justify"">3. Sitting, but with assistance;</p><p align=""justify"">4. Sitting without assistance:</p><p align=""justify"">(a) Child sits up straight with the head erect for at least 10 seconds;</p><p align=""justify"">(b) Child does not use arms or hands to balance body or support position.</p><p align=""justify"">5. Hands and knees crawling:</p><p align=""justify"">(a) Child alternately moves forward or backwards on hands and knees;</p><p align=""justify"">(b) The stomach does not touch the supporting surface;</p><p align=""justify"">(c) There are continuous and consecutive movements at least 3 in a row.</p><p align=""justify"">6. Standing with assistance:</p><p align=""justify"">(a) Child stands in upright position on both feet, holding onto a stable object (e.g. furniture) with both hands and without leaning on object;</p><p align=""justify"">(b)The body does not touch the stable object, and the legs support most of the body weight;</p><p align=""justify"">(c) Child thus stands with assistance for at least 10 seconds.</p><p align=""justify"">7. Standing alone:</p><p align=""justify"">(a) Child stands in upright position on both feet (not on the toes) with the back straight;</p><p align=""justify"">(b) The leg supports 100% of the child&apos;s weight;</p><p align=""justify"">(c) There is no contact with a person or object;</p><p align=""justify"">(d) Child stands alone for at least 10 seconds.</p><p align=""justify"">8. Walking with assistance:</p><p align=""justify"">(a) Child is in an upright position with the back straight;</p><p align=""justify"">(b) Child makes sideways or forced steps by holding onto a stable object (e.g. furniture) with 1 or both hands;</p><p align=""justify"">(c) One leg moves forward while the other supports part of the body weight;</p><p align=""justify"">(d) Child takes at least 5 steps in this manner.</p><p align=""justify"">9. Walking alone:</p><p align=""justify"">(a) Child takes at least 5 steps independently in upright position with the back straight;</p><p align=""justify"">(b) One leg moves forward while the other supports most of the body weight;</p><p align=""justify"">(c) There is no contact with a person or object.</p><p align=""justify"">Confirm which developmental state has regressed by: (i) stating the overall developmental state (1 - 9) the patient was in at the time of gene therapy, or, the best developmental state achieved since gene therapy, and (ii) stating the patient&apos;s current overall developmental state (i.e. a number that is lower than stated in (i).</p><p align=""justify"">Where the patient has neither regressed from a developmental state nor reached the next developmental state, PBS-subsidy of this benefit is not available.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Initial treatment occurring after onasemnogene abeparvovec therapy in a patient with one of: (i) Type 1 SMA, or, (ii) pre-symptomatic SMA</p><br/><p>Patient must have experienced a regression in a developmental state listed below (see ''Definition'') despite treatment with gene therapy - confirm that this: (i) not due to an acute concomitant illness; (ii) not due to non-compliance to best-supportive care, (iii) apparent for at least 3 months, (iv) verified by another clinician in the treatment team - state the full name of this clinician plus their profession (e.g. medical practitioner, nurse, physiotherapist; this is not an exhaustive list of examples); AND</p> <p>The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Patient must be undergoing treatment under this Treatment phase listing once only - for continuing treatment beyond this authority application, refer to the drug''s relevant ''Continuing treatment'' listing for the patient''s SMA type; AND</p> <p>Patient must have a prior authority approval for any drug PBS-listed for symptomatic Type 1 SMA, with at least one approval having been for gene therapy; or</p> <p>Patient must have a prior authority approval for any drug PBS-listed for pre-symptomatic SMA, with at least one approval having been for gene therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.</p><p align=""justify"">Confirm that a previous PBS authority application has been approved for one of the following:</p><p align=""justify"">(i) Symptomatic Type 1 SMA; or</p><p align=""justify"">(ii) Pre-symptomatic SMA treated with nusinersen.</p> <p align=""justify"">Definition:</p><p align=""justify"">Various childhood developmental states (1 to 9) are listed below, some followed by further observations (a up to d). Where at least one developmental state/observation is no longer present, that developmental state has regressed.</p><p align=""justify"">0. Absence of developmental states (1 to 9) listed below:</p><p align=""justify"">1. Rolls from side to side on back;</p><p align=""justify"">2. Child holds head erect for at least 3 seconds unsupported;</p><p align=""justify"">3. Sitting, but with assistance;</p><p align=""justify"">4. Sitting without assistance:</p><p align=""justify"">(a) Child sits up straight with the head erect for at least 10 seconds;</p><p align=""justify"">(b) Child does not use arms or hands to balance body or support position.</p><p align=""justify"">5. Hands and knees crawling:</p><p align=""justify"">(a) Child alternately moves forward or backwards on hands and knees;</p><p align=""justify"">(b) The stomach does not touch the supporting surface;</p><p align=""justify"">(c) There are continuous and consecutive movements at least 3 in a row.</p><p align=""justify"">6. Standing with assistance:</p><p align=""justify"">(a) Child stands in upright position on both feet, holding onto a stable object (e.g. furniture) with both hands and without leaning on object;</p><p align=""justify"">(b)The body does not touch the stable object, and the legs support most of the body weight;</p><p align=""justify"">(c) Child thus stands with assistance for at least 10 seconds.</p><p align=""justify"">7. Standing alone:</p><p align=""justify"">(a) Child stands in upright position on both feet (not on the toes) with the back straight;</p><p align=""justify"">(b) The leg supports 100% of the child&apos;s weight;</p><p align=""justify"">(c) There is no contact with a person or object;</p><p align=""justify"">(d) Child stands alone for at least 10 seconds.</p><p align=""justify"">8. Walking with assistance:</p><p align=""justify"">(a) Child is in an upright position with the back straight;</p><p align=""justify"">(b) Child makes sideways or forced steps by holding onto a stable object (e.g. furniture) with 1 or both hands;</p><p align=""justify"">(c) One leg moves forward while the other supports part of the body weight;</p><p align=""justify"">(d) Child takes at least 5 steps in this manner.</p><p align=""justify"">9. Walking alone:</p><p align=""justify"">(a) Child takes at least 5 steps independently in upright position with the back straight;</p><p align=""justify"">(b) One leg moves forward while the other supports most of the body weight;</p><p align=""justify"">(c) There is no contact with a person or object.</p><p align=""justify"">Confirm which developmental state has regressed by: (i) stating the overall developmental state (1 - 9) the patient was in at the time of gene therapy, or, the best developmental state achieved since gene therapy, and (ii) stating the patient&apos;s current overall developmental state (i.e. a number that is lower than stated in (i).</p><p align=""justify"">Where the patient has neither regressed from a developmental state nor reached the next developmental state, PBS-subsidy of this benefit is not available.</p>","N","N","N","FULL","ALL","N","2026-03-01","Y","4708"
"18122_18113_R","null","STREAMLINED","18113","18122","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of greater than 40%; AND</p> <p>Patient must have documented evidence of structural changes in the heart on echocardiography that would be expected to cause diastolic dysfunction (e.g. left ventricular hypertrophy); AND</p> <p>Patient must have documented evidence of at least one of the following: (i) diastolic dysfunction with high filling pressure on echocardiography, stress echocardiography or cardiac catheterisation; (ii) hospitalisation for heart failure in the 12 months prior to initiating treatment with this drug; (iii) requirement for intravenous diuretic therapy in the 12 months prior to initiating treatment with this drug; (iv) elevated N-terminal pro brain natriuretic peptide (NT-proBNP) levels in the absence of another cause; AND</p> <p>Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of greater than 40%; AND</p> <p>Patient must have documented evidence of structural changes in the heart on echocardiography that would be expected to cause diastolic dysfunction (e.g. left ventricular hypertrophy); AND</p> <p>Patient must have documented evidence of at least one of the following: (i) diastolic dysfunction with high filling pressure on echocardiography, stress echocardiography or cardiac catheterisation; (ii) hospitalisation for heart failure in the 12 months prior to initiating treatment with this drug; (iii) requirement for intravenous diuretic therapy in the 12 months prior to initiating treatment with this drug; (iv) elevated N-terminal pro brain natriuretic peptide (NT-proBNP) levels in the absence of another cause; AND</p> <p>Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18123_18055_R","null","STREAMLINED","18055","18123","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18124_18124_R","Initial treatment (Cycle 1, Day 15)","AUTHORITY_REQUIRED","18124","18124","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Initial treatment (Cycle 1, Day 15)</p><br/><p>Patient must be currently unable to receive treatment with CAR-T cell therapy for this condition; AND</p> <p>Patient must be unsuitable for stem cell transplant; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have received or intend to receive a Cycle 1, Day 8 dose of glofitamab for this indication; AND</p> <p>The treatment must be given in combination with gemcitabine and oxaliplatin for the first 8 cycles unless the patient has a contraindication/toxicity necessitating discontinuation of one or both chemotherapy components.</p> <p align=""justify"">Glofitamab should be administered as an intravenous infusion according to the dose step-up schedule in Cycle 1 (2.5 mg on Day 8 and 10 mg on Day 15) leading to the recommended dosage of 30 mg on Day 1 of Cycles 2-12. Refer to the TGA approved Product Information.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Initial treatment (Cycle 1, Day 15)</p><br/><p>Patient must be currently unable to receive treatment with CAR-T cell therapy for this condition; AND</p> <p>Patient must be unsuitable for stem cell transplant; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have received or intend to receive a Cycle 1, Day 8 dose of glofitamab for this indication; AND</p> <p>The treatment must be given in combination with gemcitabine and oxaliplatin for the first 8 cycles unless the patient has a contraindication/toxicity necessitating discontinuation of one or both chemotherapy components.</p> <p align=""justify"">Glofitamab should be administered as an intravenous infusion according to the dose step-up schedule in Cycle 1 (2.5 mg on Day 8 and 10 mg on Day 15) leading to the recommended dosage of 30 mg on Day 1 of Cycles 2-12. Refer to the TGA approved Product Information.</p>","N","N","N","IMMEDIATE","ALL","N","2026-03-01","N","4708"
"18126_18377_R","Continuing treatment","AUTHORITY_REQUIRED","18377","18126","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory multiple myeloma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment with this drug for this condition; AND</p> <p>Patient must have had progressive disease after receiving at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, and (iii) an anti-CD38 monoclonal antibody; or</p> <p>Patient must have been refractory to, at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, (iii) an anti-CD38 monoclonal antibody; AND</p> <p>Patient must not have previously received treatment with another B-cell maturation antigen (BCMA) directed therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less prior to initiating treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Prescribers may request the number of vials in line with the dosing requirement for each stage of treatment with the intention of providing the number of vials for each 4-weeks of treatment (24-weeks of treatment including repeats). Up to 4 vials with 5 repeats may be requested for a patient undergoing treatment in weeks 2-26. Up to 2 vials with 5 repeats may be requested for a patient undergoing treatment from week 27 onwards. Requests beyond what is listed in the TGA approved product information will not be approved.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory multiple myeloma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received treatment with this drug for this condition; AND</p> <p>Patient must have had progressive disease after receiving at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, and (iii) an anti-CD38 monoclonal antibody; or</p> <p>Patient must have been refractory to, at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, (iii) an anti-CD38 monoclonal antibody; AND</p> <p>Patient must not have previously received treatment with another B-cell maturation antigen (BCMA) directed therapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less prior to initiating treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Prescribers may request the number of vials in line with the dosing requirement for each stage of treatment with the intention of providing the number of vials for each 4-weeks of treatment (24-weeks of treatment including repeats). Up to 4 vials with 5 repeats may be requested for a patient undergoing treatment in weeks 2-26. Up to 2 vials with 5 repeats may be requested for a patient undergoing treatment from week 27 onwards. Requests beyond what is listed in the TGA approved product information will not be approved.</p>","N","N","N","IMMEDIATE","ALL","Y","2026-04-01","N","4708"
"18127_18232_R","null","AUTHORITY_REQUIRED","18232","18127","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bridging therapy for generalised myasthenia gravis (gMG)</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must be receiving concomitant treatment with an oral corticosteroid; AND</p> <p>Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for 3 months; (ii) oral corticosteroids for 3 months; (iii) a thymectomy; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must not receive more than 6 months of bridging treatment with any gMG biological agent under this PBS indication; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing and must include:</p><p align=""justify"">(a) the MG-ADL and MGC score after 3-months of remission-inducing treatments (include the date the assessments were conducted);</p><p align=""justify"">(b) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy].</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A retrospective assessment for one of the MGC score or MG-ADL score can be accepted in cases where it was not conducted after completing 3 months of remission inducing treatments.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bridging therapy for generalised myasthenia gravis (gMG)</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must be receiving concomitant treatment with an oral corticosteroid; AND</p> <p>Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for 3 months; (ii) oral corticosteroids for 3 months; (iii) a thymectomy; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must not receive more than 6 months of bridging treatment with any gMG biological agent under this PBS indication; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing and must include:</p><p align=""justify"">(a) the MG-ADL and MGC score after 3-months of remission-inducing treatments (include the date the assessments were conducted);</p><p align=""justify"">(b) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy].</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A retrospective assessment for one of the MGC score or MG-ADL score can be accepted in cases where it was not conducted after completing 3 months of remission inducing treatments.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18130_18131_R","Loading dose","AUTHORITY_REQUIRED","18131","18130","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bridging therapy for generalised myasthenia gravis (gMG)</p><br/><p>Loading dose</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must be receiving concomitant treatment with an oral corticosteroid; AND</p> <p>Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for 3 months; (ii) oral corticosteroids for 3 months; (iii) a thymectomy; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must not receive more than 6 months of bridging treatment with any gMG biological agent under this PBS indication (''bridging therapy for gMG''); AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.</p><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing and must include:</p><p align=""justify"">(a) the MG-ADL and MGC score after 3-months of remission-inducing treatments (include the date the assessments were conducted);</p><p align=""justify"">(b) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy].</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A retrospective assessment for one of the MGC score or MG-ADL score can be accepted in cases where it was not conducted after completing 3 months of remission inducing treatments.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bridging therapy for generalised myasthenia gravis (gMG)</p><br/><p>Loading dose</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must be receiving concomitant treatment with an oral corticosteroid; AND</p> <p>Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for 3 months; (ii) oral corticosteroids for 3 months; (iii) a thymectomy; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must not receive more than 6 months of bridging treatment with any gMG biological agent under this PBS indication (''bridging therapy for gMG''); AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.</p><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing and must include:</p><p align=""justify"">(a) the MG-ADL and MGC score after 3-months of remission-inducing treatments (include the date the assessments were conducted);</p><p align=""justify"">(b) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy].</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A retrospective assessment for one of the MGC score or MG-ADL score can be accepted in cases where it was not conducted after completing 3 months of remission inducing treatments.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18136_18238_R","Continuing treatment - Treatment refractory gMG patients","AUTHORITY_REQUIRED","18238","18136","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Continuing treatment - Treatment refractory gMG patients</p><br/><p>Patient must have previously received PBS-subsidised treatment with a gMG biological agent for this PBS indication; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>The treatment must provide no more than 6 months of therapy per continuing authority application; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient dose of the drug, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include the MG-ADL and MGC scores assessed from the most recent course of treatment.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Continuing treatment - Treatment refractory gMG patients</p><br/><p>Patient must have previously received PBS-subsidised treatment with a gMG biological agent for this PBS indication; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>The treatment must provide no more than 6 months of therapy per continuing authority application; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient dose of the drug, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include the MG-ADL and MGC scores assessed from the most recent course of treatment.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18138_18319_R","null","AUTHORITY_REQUIRED","18319","18138","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute severe generalised myasthenia gravis (gMG)</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must be considered by the treating clinician to have rapidly deteriorating gMG disease in the absence of immediate treatment with a gMG biological agent; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must be commencing treatment with an NS-IST within 2 weeks; or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must be receiving concomitant treatment with an oral corticosteroid; AND</p> <p>Patient must not receive more than 3 months of total treatment with gMG biological agents under this PBS indication (''acute severe gMG''); AND</p> <p>Patient must not have accessed a prior PBS-subsidised gMG biological agent; or</p> <p>Patient must have developed an intolerance/toxicity to a PBS-subsidised gMG biological agent necessitating a change in treatment; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute severe generalised myasthenia gravis (gMG)</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must be considered by the treating clinician to have rapidly deteriorating gMG disease in the absence of immediate treatment with a gMG biological agent; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must be commencing treatment with an NS-IST within 2 weeks; or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must be receiving concomitant treatment with an oral corticosteroid; AND</p> <p>Patient must not receive more than 3 months of total treatment with gMG biological agents under this PBS indication (''acute severe gMG''); AND</p> <p>Patient must not have accessed a prior PBS-subsidised gMG biological agent; or</p> <p>Patient must have developed an intolerance/toxicity to a PBS-subsidised gMG biological agent necessitating a change in treatment; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18139_18139_R","Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements","AUTHORITY_REQUIRED","18139","18139","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition as routine prophylaxis for hereditary angioedema prior to 1 April 2026; AND</p> <p>Patient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment for this condition; or</p> <p>Patient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have received PBS-subsidised treatment with lanadelumab as routine prophylaxis for hereditary angioedema immediately prior to receiving non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have received non-PBS-subsidised treatment with garadacimab via the VANGUARD open-label extension study as routine prophylaxis for hereditary angioedema; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab; AND</p> <p>Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.</p> <p align=""justify"">For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate</p> <p align=""justify"">The baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating non-PBS-subsidised treatment must be provided at the time of submitting this application.</p> <p align=""justify"">For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient&apos;s medical records for auditing purposes.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition as routine prophylaxis for hereditary angioedema prior to 1 April 2026; AND</p> <p>Patient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment for this condition; or</p> <p>Patient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have received PBS-subsidised treatment with lanadelumab as routine prophylaxis for hereditary angioedema immediately prior to receiving non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have received non-PBS-subsidised treatment with garadacimab via the VANGUARD open-label extension study as routine prophylaxis for hereditary angioedema; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab; AND</p> <p>Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.</p> <p align=""justify"">For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate</p> <p align=""justify"">The baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating non-PBS-subsidised treatment must be provided at the time of submitting this application.</p> <p align=""justify"">For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient&apos;s medical records for auditing purposes.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18141_18241_R","Continuing treatment","STREAMLINED","18241","18141","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intermediate-1 risk myelofibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intermediate-1 risk myelofibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18142_18242_R","Initial treatment - 3 weekly treatment regimen","STREAMLINED","18242","18142","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Initial treatment - 3 weekly treatment regimen</p><br/><p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must have progressed on or after prior platinum based chemotherapy; or</p> <p>The condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Initial treatment - 3 weekly treatment regimen</p><br/><p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must have progressed on or after prior platinum based chemotherapy; or</p> <p>The condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18143_18326_R","Initial treatment 1","STREAMLINED","18326","18143","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment 1</p><br/><p>Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND</p> <p>Patient must not have previously been treated for this condition in the metastatic setting; or</p> <p>The condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment 1</p><br/><p>Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND</p> <p>Patient must not have previously been treated for this condition in the metastatic setting; or</p> <p>The condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18148_18253_R","Initial treatment (covering the first 12 weeks of therapy)","AUTHORITY_REQUIRED","18253","18148","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic obstructive hypertrophic cardiomyopathy</p><br/><p>Initial treatment (covering the first 12 weeks of therapy)</p><br/><p>Patient must have confirmed left ventricular hypertrophy due to hypertrophic cardiomyopathy; AND</p> <p>Patient must have maximal end-diastolic left ventricular wall thickness which is at least one of either: (i) no less than 15 mm; (ii) no less than 13 mm if patient has familial hypertrophic cardiomyopathy (at least one first degree relative with a diagnosis of hypertrophic cardiomyopathy); AND</p> <p>Patient must have confirmed peak left ventricular outflow tract (LVOT) gradient of no less than 50 mm Hg which is measured either: (i) at rest; (ii) after provocation with at least one of (a) Valsalva manoeuvre, (b) exercise; AND</p> <p>Patient must have a current left ventricular ejection fraction (LVEF) of no less than 55%; AND</p> <p>Patient must have had prior treatments with each of a (i) beta-blocker and (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy; AND</p> <p>Patient must be undergoing concomitant treatment with at least one of: (i) a beta-blocker (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy; AND</p> <p>Patient must be symptomatic with NYHA classes II or III; AND</p> <p>Must be treated by a cardiologist; or</p> <p>Must be treated by a consultant physician with experience in the management of hypertrophic cardiomyopathy; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include all the following:</p><p align=""justify"">(1) Details of the proposed prescription; and</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">(3) The details of the echocardiogram and/ or cardiac magnetic resonance imaging (MRI) report confirming the diagnosis of hypertrophic cardiomyopathy (HCM). State all the following:</p><p align=""justify"">(a) the date, unique identifying number/code or provider number of the report;</p><p align=""justify"">(b) the left ventricular wall thickness in millimetres (mm).</p><p align=""justify"">(4) The details of a genotyping test report if the patient had been tested. State all the following:</p><p align=""justify"">(a) the date, unique identifying number/code or provider number of the report;</p><p align=""justify"">(b) if a gene has been identified that is associated with HCM;</p><p align=""justify"">(c) if any first-degree family relative has a confirmed diagnosis of HCM.</p><p align=""justify"">(5) The details of the LVOT gradient report. State all the following:</p><p align=""justify"">(a) the date, unique identifying number/code or provider number of the report;</p><p align=""justify"">(b) the measured LVOT gradient;</p><p align=""justify"">(c) how the LVOT gradient was measured (rest, Valsalva manoeuvre or exercise).</p><p align=""justify"">(6) NYHA status.</p><p align=""justify"">(7) The current beta-blocker or non-dihydropyridine calcium channel blocker (either diltiazem or verapamil only) therapy if applicable.</p><p align=""justify"">(8) Prior beta-blocker or non-dihydropyridine calcium channel blocker trials, including:</p><p align=""justify"">(a) if the patient is currently taking beta-blocker therapy, state the previous therapy with non-dihydropyridine calcium channel blocker that was trialled confirming that it was not effective;</p><p align=""justify"">(b) if the patient is currently taking non-dihydropyridine calcium channel blocker therapy, state the previous therapy with beta-blocker that was trialled confirming that it was not effective;</p><p align=""justify"">(c) if there is contraindication or intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information, specify the details.</p><p align=""justify"">All results and reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic obstructive hypertrophic cardiomyopathy</p><br/><p>Initial treatment (covering the first 12 weeks of therapy)</p><br/><p>Patient must have confirmed left ventricular hypertrophy due to hypertrophic cardiomyopathy; AND</p> <p>Patient must have maximal end-diastolic left ventricular wall thickness which is at least one of either: (i) no less than 15 mm; (ii) no less than 13 mm if patient has familial hypertrophic cardiomyopathy (at least one first degree relative with a diagnosis of hypertrophic cardiomyopathy); AND</p> <p>Patient must have confirmed peak left ventricular outflow tract (LVOT) gradient of no less than 50 mm Hg which is measured either: (i) at rest; (ii) after provocation with at least one of (a) Valsalva manoeuvre, (b) exercise; AND</p> <p>Patient must have a current left ventricular ejection fraction (LVEF) of no less than 55%; AND</p> <p>Patient must have had prior treatments with each of a (i) beta-blocker and (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy; AND</p> <p>Patient must be undergoing concomitant treatment with at least one of: (i) a beta-blocker (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy; AND</p> <p>Patient must be symptomatic with NYHA classes II or III; AND</p> <p>Must be treated by a cardiologist; or</p> <p>Must be treated by a consultant physician with experience in the management of hypertrophic cardiomyopathy; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include all the following:</p><p align=""justify"">(1) Details of the proposed prescription; and</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">(3) The details of the echocardiogram and/ or cardiac magnetic resonance imaging (MRI) report confirming the diagnosis of hypertrophic cardiomyopathy (HCM). State all the following:</p><p align=""justify"">(a) the date, unique identifying number/code or provider number of the report;</p><p align=""justify"">(b) the left ventricular wall thickness in millimetres (mm).</p><p align=""justify"">(4) The details of a genotyping test report if the patient had been tested. State all the following:</p><p align=""justify"">(a) the date, unique identifying number/code or provider number of the report;</p><p align=""justify"">(b) if a gene has been identified that is associated with HCM;</p><p align=""justify"">(c) if any first-degree family relative has a confirmed diagnosis of HCM.</p><p align=""justify"">(5) The details of the LVOT gradient report. State all the following:</p><p align=""justify"">(a) the date, unique identifying number/code or provider number of the report;</p><p align=""justify"">(b) the measured LVOT gradient;</p><p align=""justify"">(c) how the LVOT gradient was measured (rest, Valsalva manoeuvre or exercise).</p><p align=""justify"">(6) NYHA status.</p><p align=""justify"">(7) The current beta-blocker or non-dihydropyridine calcium channel blocker (either diltiazem or verapamil only) therapy if applicable.</p><p align=""justify"">(8) Prior beta-blocker or non-dihydropyridine calcium channel blocker trials, including:</p><p align=""justify"">(a) if the patient is currently taking beta-blocker therapy, state the previous therapy with non-dihydropyridine calcium channel blocker that was trialled confirming that it was not effective;</p><p align=""justify"">(b) if the patient is currently taking non-dihydropyridine calcium channel blocker therapy, state the previous therapy with beta-blocker that was trialled confirming that it was not effective;</p><p align=""justify"">(c) if there is contraindication or intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information, specify the details.</p><p align=""justify"">All results and reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18149_18145_R","Initial treatment","AUTHORITY_REQUIRED","18145","18149","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central retinal vein occlusion with macular oedema</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central retinal vein occlusion with macular oedema</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18151_18338_R","null","STREAMLINED","18338","18151","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be symptomatic with NYHA classes II, III or IV; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance; AND</p> <p>Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must not be co-administered with an ACE inhibitor or an angiotensin II antagonist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be symptomatic with NYHA classes II, III or IV; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance; AND</p> <p>Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must not be co-administered with an ACE inhibitor or an angiotensin II antagonist.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18152_18260_R","Continuing treatment","AUTHORITY_REQUIRED","18260","18152","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised ravulizumab under the initial treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the continuing treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised ravulizumab under the grandfather restriction for this condition; AND</p> <p>Patient must have demonstrated ongoing treatment response with PBS-subsidised ravulizumab for this condition; AND</p> <p>Patient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must not receive more than 72 weeks of ravulizumab treatment in total under this restriction; or</p> <p>Patient must not receive more than 104 weeks supply of a C5 inhibitor under the initial and continuing treatment restrictions if they had switched C5 inhibitors during the course of initial and continuing treatment; AND</p> <p>Patient must not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS, if applicable;</p><p align=""justify"">(6) A history of kidney transplant if applicable (especially if required due to aHUS);</p><p align=""justify"">(7) An inclusion of the individual consequences of recurrent disease, if applicable;</p><p align=""justify"">(8) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;</p><p align=""justify"">(9) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(10) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p align=""justify"">This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received PBS-subsidised ravulizumab under the initial treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the continuing treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised ravulizumab under the grandfather restriction for this condition; AND</p> <p>Patient must have demonstrated ongoing treatment response with PBS-subsidised ravulizumab for this condition; AND</p> <p>Patient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must not receive more than 72 weeks of ravulizumab treatment in total under this restriction; or</p> <p>Patient must not receive more than 104 weeks supply of a C5 inhibitor under the initial and continuing treatment restrictions if they had switched C5 inhibitors during the course of initial and continuing treatment; AND</p> <p>Patient must not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS, if applicable;</p><p align=""justify"">(6) A history of kidney transplant if applicable (especially if required due to aHUS);</p><p align=""justify"">(7) An inclusion of the individual consequences of recurrent disease, if applicable;</p><p align=""justify"">(8) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;</p><p align=""justify"">(9) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(10) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p align=""justify"">This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 8 weeks of treatment and up to 2 repeats, according to the specified dosage in the approved Product Information (PI). With 2 repeat prescriptions, this treatment phase listing intends to provide approximately 24 weeks of treatment per continuing course, i.e., an authority application must be submitted every 24 weeks under this restriction if patient is deemed eligible.</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18154_18262_R","Extended continuing treatment","AUTHORITY_REQUIRED","18262","18154","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Extended continuing treatment</p><br/><p>Patient must have received PBS-subsidised ravulizumab under the continuing treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the continuing treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the extended continuing treatment phase for this condition; AND</p> <p>Patient must have demonstrated ongoing treatment response with PBS-subsidised ravulizumab for this condition; AND</p> <p>Patient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40% on current objective measurement; or</p> <p>Patient must have severe TMA-related neurological impairment; or</p> <p>Patient must have severe TMA-related gastrointestinal impairment; or</p> <p>Patient must have severe TMA-related pulmonary impairment on current objective measurement; or</p> <p>Patient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 mL/min); or</p> <p>Patient must have a high risk of aHUS recurrence in the short term in the absence of continued treatment with ravulizumab; AND</p> <p>Patient must not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS, if applicable;</p><p align=""justify"">(6) A history of multiple episodes of aHUS before commencing ravulizumab treatment, if applicable;</p><p align=""justify"">(7) A history of kidney transplant, if applicable (especially if required due to aHUS);</p><p align=""justify"">(8) An inclusion of the individual consequences of recurrent disease;</p><p align=""justify"">(9) A supporting statement with clinical evidence of severe TMA-related cardiomyopathy (including current LVEF result), neurological impairment, gastrointestinal impairment or pulmonary impairment;</p><p align=""justify"">(10) Evidence that the patient has had a treatment response including haematological results of no more than 4 weeks old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 4 weeks old at the time of application;</p><p align=""justify"">(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(12) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p align=""justify"">This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Extended continuing treatment</p><br/><p>Patient must have received PBS-subsidised ravulizumab under the continuing treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the continuing treatment phase for this condition; or</p> <p>Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the extended continuing treatment phase for this condition; AND</p> <p>Patient must have demonstrated ongoing treatment response with PBS-subsidised ravulizumab for this condition; AND</p> <p>Patient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40% on current objective measurement; or</p> <p>Patient must have severe TMA-related neurological impairment; or</p> <p>Patient must have severe TMA-related gastrointestinal impairment; or</p> <p>Patient must have severe TMA-related pulmonary impairment on current objective measurement; or</p> <p>Patient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 mL/min); or</p> <p>Patient must have a high risk of aHUS recurrence in the short term in the absence of continued treatment with ravulizumab; AND</p> <p>Patient must not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS, if applicable;</p><p align=""justify"">(6) A history of multiple episodes of aHUS before commencing ravulizumab treatment, if applicable;</p><p align=""justify"">(7) A history of kidney transplant, if applicable (especially if required due to aHUS);</p><p align=""justify"">(8) An inclusion of the individual consequences of recurrent disease;</p><p align=""justify"">(9) A supporting statement with clinical evidence of severe TMA-related cardiomyopathy (including current LVEF result), neurological impairment, gastrointestinal impairment or pulmonary impairment;</p><p align=""justify"">(10) Evidence that the patient has had a treatment response including haematological results of no more than 4 weeks old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 4 weeks old at the time of application;</p><p align=""justify"">(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(12) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p align=""justify"">This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 8 weeks of treatment and up to 2 repeats, according to the specified dosage in the approved Product Information (PI). With 2 repeat prescriptions, this treatment phase listing intends to provide approximately 24 weeks of treatment per continuing course, i.e., an authority application must be submitted every 24 weeks under this restriction if patient is deemed eligible.</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18156_18153_R","Continuing recommencement of treatment","AUTHORITY_REQUIRED","18153","18156","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Continuing recommencement of treatment</p><br/><p>Patient must have received PBS-subsidised ravulizumab under the ''Recommencement of treatment'' restriction for this condition; or</p> <p>Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab ''Recommencement treatment'' restriction for this condition; or</p> <p>Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab ''Continuing recommencement treatment'' restriction for this condition; AND</p> <p>Patient must have demonstrated ongoing treatment response to ''Recommencement of treatment'' with a C5 inhibitor for this condition; AND</p> <p>Patient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS, if applicable;</p><p align=""justify"">(6) A history of multiple episodes of aHUS before recommencing ravulizumab treatment, if applicable;</p><p align=""justify"">(7) A history of kidney transplant if applicable (especially if required due to aHUS);</p><p align=""justify"">(8) An inclusion of the individual consequences of recurrent disease, if applicable;</p><p align=""justify"">(9) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;</p><p align=""justify"">(10) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(11) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p align=""justify"">This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Continuing recommencement of treatment</p><br/><p>Patient must have received PBS-subsidised ravulizumab under the ''Recommencement of treatment'' restriction for this condition; or</p> <p>Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab ''Recommencement treatment'' restriction for this condition; or</p> <p>Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab ''Continuing recommencement treatment'' restriction for this condition; AND</p> <p>Patient must have demonstrated ongoing treatment response to ''Recommencement of treatment'' with a C5 inhibitor for this condition; AND</p> <p>Patient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS, if applicable;</p><p align=""justify"">(6) A history of multiple episodes of aHUS before recommencing ravulizumab treatment, if applicable;</p><p align=""justify"">(7) A history of kidney transplant if applicable (especially if required due to aHUS);</p><p align=""justify"">(8) An inclusion of the individual consequences of recurrent disease, if applicable;</p><p align=""justify"">(9) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;</p><p align=""justify"">(10) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(11) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p align=""justify"">This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 8 weeks of treatment and up to 2 repeats, according to the specified dosage in the approved Product Information (PI). With 2 repeat prescriptions, this treatment phase listing intends to provide approximately 24 weeks of treatment per continuing course, i.e., an authority application must be submitted every 24 weeks under this restriction if patient is deemed eligible.</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18157_18158_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","18158","18157","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18159_18340_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","18340","18159","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 18 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must not receive more than 18 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""justify"">The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and</p><p align=""justify"">(iv) baseline ESR and/or CRP level.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted for the purposes of administering this restriction can be found on the Services Australia website at www.servicesaustralia.gov.au</p> <p align=""justify"">For details on the appropriate minimum exercise program that will be accepted for the purposes of administering this restriction, please refer to the Services Australia website at www.servicesaustralia.gov.au</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18160_18162_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18162","18160","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 18 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 18 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18161_18462_R","First continuing treatment","AUTHORITY_REQUIRED","18462","18161","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following:</p><p align=""justify"">(a) an ESR measurement no greater than 25 mm per hour; or</p><p align=""justify"">(b) a CRP measurement no greater than 10 mg per L; or</p><p align=""justify"">(c) an ESR or CRP measurement reduced by at least 20% from baseline.</p><p align=""justify"">Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.</p> <p align=""justify"">The assessment of response to treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18163_18389_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","18389","18163","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">Each application for subsequent continuing treatment with this drug must include an assessment of the patient&apos;s response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">Each application for subsequent continuing treatment with this drug must include an assessment of the patient&apos;s response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18166_18267_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","18267","18166","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18167_18272_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","18272","18167","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.</p> <p align=""justify"">Up to a maximum of 4 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.</p> <p align=""justify"">Up to a maximum of 4 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18168_18274_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","18274","18168","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18170_18169_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","18169","18170","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.</p> <p align=""justify"">Up to a maximum of 4 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.</p> <p align=""justify"">Up to a maximum of 4 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18171_18273_R","First continuing treatment","AUTHORITY_REQUIRED","18273","18171","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18173_18276_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","18276","18173","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18175_18275_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","18275","18175","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18176_18172_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","18172","18176","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18178_18348_R","Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)","AUTHORITY_REQUIRED","18348","18178","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.</p> <p align=""justify"">If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p/><p align=""justify"">An adequate response to treatment is defined as:</p><p/><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or </p><p/><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p/><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p/><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p><p/> <p>At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.</p> <p align=""justify"">If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p/><p align=""justify"">An adequate response to treatment is defined as:</p><p/><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or </p><p/><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p/><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p/><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p><p/> <p>At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, and etanercept for patients who have severe active juvenile idiopathic arthritis.</p><p align=""justify"">This listing is a temporary listing and is only to be used to transfer patients currently receiving PBS subsidised treatment with tocilizumab to another biological medicine, where tocilizumab is not available due to the current critical medicines shortage.</p><p align=""justify"">Alternative biological medicine refers to adalimumab and etanercept.</p><p align=""justify"">Should it be necessary to continue treatment with the alternative biological medicine, applications must be made under the relevant &apos;First continuing - Temporary listing&apos; PBS listing.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18179_18279_R","Continuing treatment","AUTHORITY_REQUIRED","18279","18179","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18181_18283_R","Recommencement of treatment","AUTHORITY_REQUIRED","18283","18181","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have demonstrated treatment response to previous treatment with a PBS-subsidised C5 inhibitor for this condition; AND</p> <p>Patient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must have the following clinical conditions prior to recommencing C5 inhibitor treatment: (i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal; AND (ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L); OR (iii) TMA-related organ impairment including on recent biopsy; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS if applicable;</p><p align=""justify"">(6) A history of multiple episodes of aHUS following the treatment break, if applicable;</p><p align=""justify"">(7) A history of kidney transplant if applicable (especially if required due to aHUS);</p><p align=""justify"">(8) An inclusion of the individual consequences of recurrent disease;</p><p align=""justify"">(9) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy;</p><p align=""justify"">(10) Evidence that the patient has had a treatment response to their previous treatment with a C5 inhibitor;</p><p align=""justify"">(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(12) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p align=""justify"">Two authority prescription forms will be required to cover for the 26 weeks of recommencement therapy with ravulizumab, one for the loading dose and one for the 24 week balance which can be sought under the Balance of Supply.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Recommencement of treatment</p><br/><p>Patient must have demonstrated treatment response to previous treatment with a PBS-subsidised C5 inhibitor for this condition; AND</p> <p>Patient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; AND</p> <p>Patient must have the following clinical conditions prior to recommencing C5 inhibitor treatment: (i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal; AND (ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L); OR (iii) TMA-related organ impairment including on recent biopsy; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">A treatment response is defined as:</p><p align=""justify"">(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and</p><p align=""justify"">(2) One of the following:</p><p align=""justify"">a) an increase in eGFR of &gt; 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or</p><p align=""justify"">b) an eGFR within +/- 25% from baseline; or</p><p align=""justify"">c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR &gt; 25% from baseline.</p> <p align=""justify"">PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.</p><p align=""justify"">A treatment failure is defined as a patient who is:</p><p align=""justify"">(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or</p><p align=""justify"">(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.</p> <p align=""justify"">The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted;</p><p align=""justify"">(5) A family history of aHUS if applicable;</p><p align=""justify"">(6) A history of multiple episodes of aHUS following the treatment break, if applicable;</p><p align=""justify"">(7) A history of kidney transplant if applicable (especially if required due to aHUS);</p><p align=""justify"">(8) An inclusion of the individual consequences of recurrent disease;</p><p align=""justify"">(9) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy;</p><p align=""justify"">(10) Evidence that the patient has had a treatment response to their previous treatment with a C5 inhibitor;</p><p align=""justify"">(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;</p><p align=""justify"">(12) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.</p> <p align=""justify"">Two authority prescription forms will be required to cover for the 26 weeks of recommencement therapy with ravulizumab, one for the loading dose and one for the 24 week balance which can be sought under the Balance of Supply.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 2 weeks of treatment, according to the specified dosage in the approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p> <p align=""justify"">A raise in LDH alone is not a sufficient reason to recommence a C5 inhibitor, but thrombocytopenia with one marker of haemolysis (such as raised LDH, presence of schistocytes, or low/absence of haptoglobin) is an accepted reason to consider recommencement of C5 inhibitor treatment.</p> <p align=""justify"">Kidney transplantation/dialysis is not a contraindication to recommencement of C5 inhibitor treatment.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18182_18351_R","Initial treatment - Initial (new patient) loading dose","AUTHORITY_REQUIRED","18351","18182","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Initial treatment - Initial (new patient) loading dose</p><br/><p>Patient must have active and progressing thrombotic microangiopathy (TMA) caused by aHUS; AND</p> <p>Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample taken prior to plasma exchange or infusion; or, if ADAMTS-13 activity was not collected prior to plasma exchange or infusion, patient must have platelet counts of greater than 30x10^9/L and a serum creatinine of greater than 150 mol/L; AND</p> <p>Patient must have a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days; AND</p> <p>Patient must have clinical features of active organ damage or impairment; AND</p> <p>Patient must not receive more than 2 weeks of treatment under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">Evidence of active and progressing TMA is defined by the following:</p><p align=""justify"">(1) A platelet count of less than 150x10^9/L; and evidence of at least two of the following:</p><p align=""justify"">(i) presence of schistocytes on blood film;</p><p align=""justify"">(ii) low or absent haptoglobin;</p><p align=""justify"">(iii) lactate dehydrogenase (LDH) above normal range; or</p><p align=""justify"">(2) In recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA; and</p><p align=""justify"">(3) Evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:</p><p align=""justify"">(a) kidney impairment as demonstrated by one or more of the following:</p><p align=""justify"">(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment;</p><p align=""justify"">(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment;</p><p align=""justify"">(iii) a sCr of greater than the age-appropriate ULN in paediatric patients;</p><p align=""justify"">(iv) a renal biopsy consistent with aHUS;</p><p align=""justify"">(b) onset of TMA-related neurological impairment;</p><p align=""justify"">(c) onset of TMA-related cardiac impairment;</p><p align=""justify"">(d) onset of TMA-related gastrointestinal impairment;</p><p align=""justify"">(e) onset of TMA-related pulmonary impairment.</p><p align=""justify"">Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised ravulizumab (where possible), and should be supported by objective clinical measures.</p><p align=""justify"">The prescriber&apos;s cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A detailed cover letter from the prescriber;</p><p align=""justify"">(4) A measurement of body weight at the time of application;</p><p align=""justify"">(5) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay;</p><p align=""justify"">(6) In the case that a sample for ADAMTS-13 assay was not collected prior to plasma exchange or infusion, measurement of ADAMTS-13 activity must be taken 7-10 days following the last plasma exchange or infusion. The ADAMTS-13 result must be submitted to Services Australia within 13 days of commencement of ravulizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised C5 inhibitor treatment, under Initial balance of supply;</p><p align=""justify"">(7) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days;</p><p align=""justify"">(8) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within 4 weeks of application;</p><p align=""justify"">(9) For all patients, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.</p> <p align=""justify"">Two authority prescription forms will be required to cover for the 26 weeks of initial therapy with ravulizumab, one for the loading dose and one for the 24 week balance which can be sought under the Balance of Supply.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Initial treatment - Initial (new patient) loading dose</p><br/><p>Patient must have active and progressing thrombotic microangiopathy (TMA) caused by aHUS; AND</p> <p>Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample taken prior to plasma exchange or infusion; or, if ADAMTS-13 activity was not collected prior to plasma exchange or infusion, patient must have platelet counts of greater than 30x10^9/L and a serum creatinine of greater than 150 mol/L; AND</p> <p>Patient must have a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days; AND</p> <p>Patient must have clinical features of active organ damage or impairment; AND</p> <p>Patient must not receive more than 2 weeks of treatment under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">Evidence of active and progressing TMA is defined by the following:</p><p align=""justify"">(1) A platelet count of less than 150x10^9/L; and evidence of at least two of the following:</p><p align=""justify"">(i) presence of schistocytes on blood film;</p><p align=""justify"">(ii) low or absent haptoglobin;</p><p align=""justify"">(iii) lactate dehydrogenase (LDH) above normal range; or</p><p align=""justify"">(2) In recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA; and</p><p align=""justify"">(3) Evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:</p><p align=""justify"">(a) kidney impairment as demonstrated by one or more of the following:</p><p align=""justify"">(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment;</p><p align=""justify"">(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment;</p><p align=""justify"">(iii) a sCr of greater than the age-appropriate ULN in paediatric patients;</p><p align=""justify"">(iv) a renal biopsy consistent with aHUS;</p><p align=""justify"">(b) onset of TMA-related neurological impairment;</p><p align=""justify"">(c) onset of TMA-related cardiac impairment;</p><p align=""justify"">(d) onset of TMA-related gastrointestinal impairment;</p><p align=""justify"">(e) onset of TMA-related pulmonary impairment.</p><p align=""justify"">Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised ravulizumab (where possible), and should be supported by objective clinical measures.</p><p align=""justify"">The prescriber&apos;s cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A detailed cover letter from the prescriber;</p><p align=""justify"">(4) A measurement of body weight at the time of application;</p><p align=""justify"">(5) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay;</p><p align=""justify"">(6) In the case that a sample for ADAMTS-13 assay was not collected prior to plasma exchange or infusion, measurement of ADAMTS-13 activity must be taken 7-10 days following the last plasma exchange or infusion. The ADAMTS-13 result must be submitted to Services Australia within 13 days of commencement of ravulizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised C5 inhibitor treatment, under Initial balance of supply;</p><p align=""justify"">(7) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days;</p><p align=""justify"">(8) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within 4 weeks of application;</p><p align=""justify"">(9) For all patients, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.</p> <p align=""justify"">Two authority prescription forms will be required to cover for the 26 weeks of initial therapy with ravulizumab, one for the loading dose and one for the 24 week balance which can be sought under the Balance of Supply.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 2 weeks of treatment, according to the specified dosage in the approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p> <p align=""justify"">The Authority application should be accompanied by a cover letter from the prescriber, providing complete details on:</p><p align=""justify"">a) Presenting clinical features, including history, acute treatment and medications;</p><p align=""justify"">b) Results of testing for genetic mutations (if available);</p><p align=""justify"">c) Family history of aHUS, especially in first-degree relatives;</p><p align=""justify"">d) Patient&apos;s prior history of episodes of active and progressing TMA caused by aHUS;</p><p align=""justify"">e) Exclusion of alternative causes of TMA;</p><p align=""justify"">f) History of renal or other organ transplant (if any);</p><p align=""justify"">g) Any other matters considered relevant by the prescriber.</p><p align=""justify"">In cases where there are discordant results (for example, an equivocal biopsy result in the absence of objective evidence of haemolysis) the cover letter should articulate the prescriber&apos;s interpretation of the clinical data and how a diagnosis of aHUS is supported by the available evidence.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18183_18350_R","Switch from PBS-subsidised eculizumab (all phases) - loading dose","AUTHORITY_REQUIRED","18350","18183","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Switch from PBS-subsidised eculizumab (all phases) - loading dose</p><br/><p>Patient must have previously received PBS-subsidised eculizumab under the ''Initial treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised eculizumab under the ''Continuing treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised eculizumab under the ''Extended continuing treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised eculizumab under the ''Recommencement of treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised eculizumab under the ''Continuing recommencement of treatment'' restriction for this condition; AND</p> <p>Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND</p> <p>Patient must not receive more than 2 weeks of treatment under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">The application must indicate the most recent treatment phase that the patient is switching from.</p> <p align=""justify"">For patients who are switching C5 inhibitors, the next application should be sought under the next relevant treatment phase.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Switch from PBS-subsidised eculizumab (all phases) - loading dose</p><br/><p>Patient must have previously received PBS-subsidised eculizumab under the ''Initial treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised eculizumab under the ''Continuing treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised eculizumab under the ''Extended continuing treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised eculizumab under the ''Recommencement of treatment'' restriction for this condition; or</p> <p>Patient must have previously received PBS-subsidised eculizumab under the ''Continuing recommencement of treatment'' restriction for this condition; AND</p> <p>Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND</p> <p>Patient must not receive more than 2 weeks of treatment under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">The application must indicate the most recent treatment phase that the patient is switching from.</p> <p align=""justify"">For patients who are switching C5 inhibitors, the next application should be sought under the next relevant treatment phase.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A measurement of body weight at the time of application;</p><p align=""justify"">(4) Results of genetic testing, if not previously submitted.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 2 weeks of treatment, according to the specified dosage in the approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18184_18434_R","Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)","AUTHORITY_REQUIRED","18434","18184","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have an externally draining enterocutaneous or rectovaginal fistula.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><ul><li>a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition.</li></ul> <p align=""justify"">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">An assessment of the patient&apos;s response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have an externally draining enterocutaneous or rectovaginal fistula.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><ul><li>a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition.</li></ul> <p align=""justify"">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">An assessment of the patient&apos;s response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">It is recommended that an application for the first continuing treatment is submitted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the first continuing treatment criteria for PBS-subsidised treatment with this drug.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18185_18285_R","First continuing treatment","AUTHORITY_REQUIRED","18285","18185","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">The application for first continuing treatment with this drug must include an assessment of the patient&apos;s response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.</p> <p align=""justify"">Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">A maximum of 24 weeks of treatment with this drug will be authorised under this restriction.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide for infusion<i>s</i> at a dose of 5 mg per kg eight weekly.</p> <p>Up to a maximum of 2 repeats will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">The application for first continuing treatment with this drug must include an assessment of the patient&apos;s response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.</p> <p align=""justify"">Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">A maximum of 24 weeks of treatment with this drug will be authorised under this restriction.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide for infusion<i>s</i> at a dose of 5 mg per kg eight weekly.</p> <p>Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18186_18466_R","Change or Recommencement of treatment after a break in therapy of less than 5 years (Initial 2)","AUTHORITY_REQUIRED","18466","18186","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Change or Recommencement of treatment after a break in therapy of less than 5 years (Initial 2)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><ol><li>a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition; and</li><li>details of prior biological medicine treatment including details of date and duration of treatment.</li></ol> <p align=""justify"">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.</p> <p align=""justify"">If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">An assessment of the patient&apos;s response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.</p> <p align=""justify"">Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Change or Recommencement of treatment after a break in therapy of less than 5 years (Initial 2)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><ol><li>a completed current Fistula Assessment Form including the date of assessment of the patient&apos;s condition; and</li><li>details of prior biological medicine treatment including details of date and duration of treatment.</li></ol> <p align=""justify"">The most recent fistula assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.</p> <p align=""justify"">If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">An assessment of the patient&apos;s response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.</p> <p align=""justify"">Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">It is recommended that an application for the first continuing treatment is submitted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the first continuing treatment criteria for PBS-subsidised treatment with this drug.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18187_18469_R","Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18469","18187","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""left"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""left"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18188_18436_R","Initial treatment - Initial 1, Whole body (new patient)","AUTHORITY_REQUIRED","18436","18188","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""left"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""left"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18192_C","null","null","null","null","null","<p/><p align=""justify""> The listed brands have NOT been shown to be bioequivalent and should not be interchanged.</p><p/>","N","Y","N","null","null","N","2016-02-01","N","4708"
"18193_18194_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18194","18193","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18195_18502_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","18502","18195","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); or</p> <p>Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""left"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8-weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An adult patient who has previously received induction therapy with PBS-subsidised treatment with this drug for an acute severe episode of ulcerative colitis in the last 4 months, and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic scoreless than or equal to 2, with no subscore greater than 1, will not be required to demonstrate failure to prior treatment with a 5-aminosalicylate oral preparation and one of azathioprine, 6-mercaptopurine or oral steroids.</p> <p align=""justify"">A patient, aged 6 to 17 years, who has previously received induction therapy with PBS-subsidised treatment with this drug for an acute severe episode of ulcerative colitis in the last 4 months, and demonstrated an adequate response to induction therapy by achieving and maintaining a PUCAI score of less than 10 will not be required to demonstrate failure to prior treatment with a 5-aminosalicylate oral preparation and one of azathioprine, 6-mercaptopurine or oral steroids.</p> <p align=""justify"">A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient&apos;s response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); or</p> <p>Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""left"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8-weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">An adult patient who has previously received induction therapy with PBS-subsidised treatment with this drug for an acute severe episode of ulcerative colitis in the last 4 months, and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic scoreless than or equal to 2, with no subscore greater than 1, will not be required to demonstrate failure to prior treatment with a 5-aminosalicylate oral preparation and one of azathioprine, 6-mercaptopurine or oral steroids.</p> <p align=""justify"">A patient, aged 6 to 17 years, who has previously received induction therapy with PBS-subsidised treatment with this drug for an acute severe episode of ulcerative colitis in the last 4 months, and demonstrated an adequate response to induction therapy by achieving and maintaining a PUCAI score of less than 10 will not be required to demonstrate failure to prior treatment with a 5-aminosalicylate oral preparation and one of azathioprine, 6-mercaptopurine or oral steroids.</p> <p align=""justify"">A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient&apos;s response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18199_18200_R","Initial treatment","AUTHORITY_REQUIRED","18200","18199","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic thromboembolic pulmonary hypertension (CTEPH)</p><br/><p>Initial treatment</p><br/><p>Patient must have WHO Functional Class II, III or IV CTEPH; AND</p> <p>The condition must be inoperable by pulmonary endarterectomy; or</p> <p>The condition must be recurrent or persistent following pulmonary endarterectomy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated in a centre with expertise in the management of CTEPH; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">CTEPH that is inoperable by pulmonary endarterectomy is defined as follows:</p><p align=""justify"">(a) Right heart catheterisation (RHC) demonstrating pulmonary vascular resistance (PVR) of greater than 300 dyn*sec*cm<sup>-5</sup> measured at least 90 days after start of full anticoagulation; and</p><p align=""justify"">(b) A mean pulmonary artery pressure (PAPmean) of greater than 25 mmHg at least 90 days after start of full anticoagulation.</p> <p align=""justify"">CTEPH that is recurrent or persistent subsequent to pulmonary endarterectomy is defined as follows:</p><p align=""justify"">RHC demonstrating a PVR of greater than 300 dyn*sec*cm<sup>-5</sup> measured at least 180 days following pulmonary endarterectomy.</p> <p align=""justify"">Where a RHC cannot be performed due to right ventricular dysfunction, an echocardiogram demonstrating the dysfunction must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the results from the 3 tests below, to establish baseline measurements, where available:</p><p align=""justify"">(i) RHC composite assessment, and</p><p align=""justify"">(ii) ECHO composite assessment, and</p><p align=""justify"">(iii) 6 Minute Walk Test (6MWT); and</p><p align=""justify"">(b) confirmation of evidence of inoperable CTEPH including the pulmonary vascular resistance (PVR) value, a mean pulmonary artery pressure (PAPmean) and the starting date of full anticoagulation; or</p><p align=""justify"">(c) confirmation of evidence of recurrent or persistent CTEPH including the PVR value and the date that pulmonary endarterectomy was performed; or</p><p align=""justify"">(d) confirmation of an echocardiogram demonstrating right ventricular dysfunction.</p><p align=""justify"">Where it is not possible to perform all 3 tests above on clinical grounds, the expected test combination, in descending order of preference is:</p><p align=""justify"">(1) RHC plus ECHO composite assessments;</p><p align=""justify"">(2) RHC composite assessment plus 6MWT;</p><p align=""justify"">(3) RHC composite assessment only.</p><p align=""justify"">In circumstance where a RHC cannot be performed on clinical grounds, the expected test combinations, in descending order of preference is:</p><p align=""justify"">(1) ECHO composite assessment plus 6MWT;</p><p align=""justify"">(2) ECHO composite assessment only.</p><p align=""justify"">Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be documented in the patient&apos;s medical records.</p><p align=""justify"">The test results provided must not be more than 2 months old at the time of application.</p> <p align=""justify"">Prescriptions for dose titration must provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions.</p> <p align=""justify"">Approvals for subsequent authority prescription will be limited to 1 month of treatment, The quantity approved must be based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 3 repeats.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial 20-week course of treatment should be made following the preceding 16 weeks of treatment, in order to allow sufficient time for a response to be demonstrated.</p> <p align=""justify"">Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic thromboembolic pulmonary hypertension (CTEPH)</p><br/><p>Initial treatment</p><br/><p>Patient must have WHO Functional Class II, III or IV CTEPH; AND</p> <p>The condition must be inoperable by pulmonary endarterectomy; or</p> <p>The condition must be recurrent or persistent following pulmonary endarterectomy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated in a centre with expertise in the management of CTEPH; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">CTEPH that is inoperable by pulmonary endarterectomy is defined as follows:</p><p align=""justify"">(a) Right heart catheterisation (RHC) demonstrating pulmonary vascular resistance (PVR) of greater than 300 dyn*sec*cm<sup>-5</sup> measured at least 90 days after start of full anticoagulation; and</p><p align=""justify"">(b) A mean pulmonary artery pressure (PAPmean) of greater than 25 mmHg at least 90 days after start of full anticoagulation.</p> <p align=""justify"">CTEPH that is recurrent or persistent subsequent to pulmonary endarterectomy is defined as follows:</p><p align=""justify"">RHC demonstrating a PVR of greater than 300 dyn*sec*cm<sup>-5</sup> measured at least 180 days following pulmonary endarterectomy.</p> <p align=""justify"">Where a RHC cannot be performed due to right ventricular dysfunction, an echocardiogram demonstrating the dysfunction must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the results from the 3 tests below, to establish baseline measurements, where available:</p><p align=""justify"">(i) RHC composite assessment, and</p><p align=""justify"">(ii) ECHO composite assessment, and</p><p align=""justify"">(iii) 6 Minute Walk Test (6MWT); and</p><p align=""justify"">(b) confirmation of evidence of inoperable CTEPH including the pulmonary vascular resistance (PVR) value, a mean pulmonary artery pressure (PAPmean) and the starting date of full anticoagulation; or</p><p align=""justify"">(c) confirmation of evidence of recurrent or persistent CTEPH including the PVR value and the date that pulmonary endarterectomy was performed; or</p><p align=""justify"">(d) confirmation of an echocardiogram demonstrating right ventricular dysfunction.</p><p align=""justify"">Where it is not possible to perform all 3 tests above on clinical grounds, the expected test combination, in descending order of preference is:</p><p align=""justify"">(1) RHC plus ECHO composite assessments;</p><p align=""justify"">(2) RHC composite assessment plus 6MWT;</p><p align=""justify"">(3) RHC composite assessment only.</p><p align=""justify"">In circumstance where a RHC cannot be performed on clinical grounds, the expected test combinations, in descending order of preference is:</p><p align=""justify"">(1) ECHO composite assessment plus 6MWT;</p><p align=""justify"">(2) ECHO composite assessment only.</p><p align=""justify"">Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be documented in the patient&apos;s medical records.</p><p align=""justify"">The test results provided must not be more than 2 months old at the time of application.</p> <p align=""justify"">Prescriptions for dose titration must provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions.</p> <p align=""justify"">Approvals for subsequent authority prescription will be limited to 1 month of treatment, The quantity approved must be based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 3 repeats.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial 20-week course of treatment should be made following the preceding 16 weeks of treatment, in order to allow sufficient time for a response to be demonstrated.</p> <p align=""justify"">Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18201_18403_R","Initial 1 (new patients)","AUTHORITY_REQUIRED","18403","18201","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 (new patients)</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>Patient must have WHO Functional Class III drug and toxins induced PAH, or WHO Functional Class IV PAH; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 (new patients)</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>Patient must have WHO Functional Class III drug and toxins induced PAH, or WHO Functional Class IV PAH; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18207_18208_R","Initial 1 (new patients)","AUTHORITY_REQUIRED","18208","18207","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 (new patients)</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>Patient must have WHO Functional Class IV PAH; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 (new patients)</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>Patient must have WHO Functional Class IV PAH; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18212_18211_R","Use in a patient untreated with disease modifying therapies for this condition","AUTHORITY_REQUIRED","18211","18212","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Use in a patient untreated with disease modifying therapies for this condition</p><br/><p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must have experienced at least two of the defined signs/symptoms of Type 1 SMA specified below; or</p> <p>The condition must be pre-symptomatic SMA, with genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; AND</p> <p>The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND</p> <p>Patient must not be undergoing treatment with this pharmaceutical benefit through this listing where prior treatment has occurred with any of: (i) nusinersen, (ii) risdiplam; AND</p> <p>Patient must be no older than 9 months of age; AND</p> <p>Patient must have symptomatic Type 1 SMA; or</p> <p>Patient must have pre-symptomatic SMA.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribing Instructions:</p><p align=""justify"">In the relevant PBS Authority Application form, specify the following:</p><p align=""justify"">(i) the SMA type being treated: symptomatic Type 1 SMA, or, pre-symptomatic SMA;</p><p align=""justify"">(ii) for Type 1 SMA, the signs/symptoms that the patient has experienced, together with the patient&apos;s age at the onset of these signs/symptoms.</p><p align=""justify"">State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.</p><p align=""justify"">Confirm that genetic testing has been completed to demonstrate the following in support of an SMA diagnosis:</p><p align=""justify"">(i) 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p><p align=""justify"">(ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.</p><p align=""justify"">If the condition is pre-symptomatic SMA, confirm that there is genetic test finding that substantiates the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).</p><p align=""justify"">Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient.</p> <p align=""justify"">Defined signs and symptoms of type I SMA are:</p><p align=""justify"">i) Onset before 6 months of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Use in a patient untreated with disease modifying therapies for this condition</p><br/><p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must have experienced at least two of the defined signs/symptoms of Type 1 SMA specified below; or</p> <p>The condition must be pre-symptomatic SMA, with genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; AND</p> <p>The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND</p> <p>Patient must not be undergoing treatment with this pharmaceutical benefit through this listing where prior treatment has occurred with any of: (i) nusinersen, (ii) risdiplam; AND</p> <p>Patient must be no older than 9 months of age; AND</p> <p>Patient must have symptomatic Type 1 SMA; or</p> <p>Patient must have pre-symptomatic SMA.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribing Instructions:</p><p align=""justify"">In the relevant PBS Authority Application form, specify the following:</p><p align=""justify"">(i) the SMA type being treated: symptomatic Type 1 SMA, or, pre-symptomatic SMA;</p><p align=""justify"">(ii) for Type 1 SMA, the signs/symptoms that the patient has experienced, together with the patient&apos;s age at the onset of these signs/symptoms.</p><p align=""justify"">State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.</p><p align=""justify"">Confirm that genetic testing has been completed to demonstrate the following in support of an SMA diagnosis:</p><p align=""justify"">(i) 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p><p align=""justify"">(ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.</p><p align=""justify"">If the condition is pre-symptomatic SMA, confirm that there is genetic test finding that substantiates the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).</p><p align=""justify"">Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient.</p> <p align=""justify"">Defined signs and symptoms of type I SMA are:</p><p align=""justify"">i) Onset before 6 months of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">An outcome on the authority application is not immediate, but will follow in due course. Electronic upload is encouraged to reduce processing time.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18214_18213_R","Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec)","AUTHORITY_REQUIRED","18213","18214","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec)</p><br/><p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit with the intent that treatment with the replaced disease modifying agent is/has ceased; AND</p> <p>Patient must be no older than 9 months of age; AND</p> <p>Patient must have symptomatic Type 1 SMA; or</p> <p>Patient must have pre-symptomatic SMA with 1-2 copies of SMN2 gene.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.</p><p align=""justify"">Confirm that a previous PBS authority application has been approved for one of the following:</p><p align=""justify"">(i) Symptomatic Type 1 SMA; or</p><p align=""justify"">(ii) Pre-symptomatic SMA with 1-2 copies of SMN2 gene.</p><p align=""justify"">State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.</p> <p align=""justify"">Adhere to any Product Information or local treatment guidelines with respect to treatment-free (&apos;wash out&apos;) periods prior to administering this benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec)</p><br/><p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND</p> <p>Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND</p> <p>Patient must be undergoing treatment with this pharmaceutical benefit with the intent that treatment with the replaced disease modifying agent is/has ceased; AND</p> <p>Patient must be no older than 9 months of age; AND</p> <p>Patient must have symptomatic Type 1 SMA; or</p> <p>Patient must have pre-symptomatic SMA with 1-2 copies of SMN2 gene.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.</p><p align=""justify"">Confirm that a previous PBS authority application has been approved for one of the following:</p><p align=""justify"">(i) Symptomatic Type 1 SMA; or</p><p align=""justify"">(ii) Pre-symptomatic SMA with 1-2 copies of SMN2 gene.</p><p align=""justify"">State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.</p> <p align=""justify"">Adhere to any Product Information or local treatment guidelines with respect to treatment-free (&apos;wash out&apos;) periods prior to administering this benefit.</p> <p align=""justify"">An outcome on the authority application is not immediate, but will follow in due course. Electronic upload is encouraged to reduce processing time.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18216_18215_R","Initial 1 (new patients)","AUTHORITY_REQUIRED","18215","18216","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 (new patients)</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>Patient must have been assessed by a physician with expertise in the management of PAH; AND</p> <p>Patient must have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">Approvals for prescriptions for dose titration will provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions.</p> <p align=""justify"">Approvals for subsequent authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 (new patients)</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>Patient must have been assessed by a physician with expertise in the management of PAH; AND</p> <p>Patient must have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">Approvals for prescriptions for dose titration will provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions.</p> <p align=""justify"">Approvals for subsequent authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18218_18364_R","Induction treatment","AUTHORITY_REQUIRED","18364","18218","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Induction treatment</p><br/><p>The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND</p> <p>Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND</p> <p>Patient must not have received more than 1 line of salvage therapy; AND</p> <p>Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND</p> <p>The condition must be CD22-positive; AND</p> <p>The condition must have more than 5% blasts in bone marrow; AND</p> <p>The treatment must not be more than 3 treatment cycles under this restriction in a lifetime.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s);</p><p align=""justify"">(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">(3) evidence that the condition is CD22-positive; and</p><p align=""justify"">(4) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and</p><p align=""justify"">(5) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application.</p> <p align=""justify"">The treatment must not exceed 0.8mg per m<sup>2</sup> for the first dose of a treatment cycle (Day 1), and 0.5mg per m<sup>2</sup> for subsequent doses (Days 8 and 15) within a treatment cycle.</p> <p align=""justify"">Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Careful monitoring of patients is required due to risk of developing hepatotoxicity, including life-threatening hepatic veno-occlusive disease, and the increased risk of post-haematopoietic stem cell transplant non-relapse mortality observed in patients treated with inotuzumab.</p> <p>Acute lymphoblastic leukaemia</p><br/><p>Induction treatment</p><br/><p>The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND</p> <p>Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND</p> <p>Patient must not have received more than 1 line of salvage therapy; AND</p> <p>Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND</p> <p>The condition must be CD22-positive; AND</p> <p>The condition must have more than 5% blasts in bone marrow; AND</p> <p>The treatment must not be more than 3 treatment cycles under this restriction in a lifetime.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s);</p><p align=""justify"">(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">(3) evidence that the condition is CD22-positive; and</p><p align=""justify"">(4) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and</p><p align=""justify"">(5) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application.</p> <p align=""justify"">The treatment must not exceed 0.8mg per m<sup>2</sup> for the first dose of a treatment cycle (Day 1), and 0.5mg per m<sup>2</sup> for subsequent doses (Days 8 and 15) within a treatment cycle.</p> <p align=""justify"">Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.</p> <p align=""justify"">Patients are eligible to receive a loading dose for the first dose of a treatment cycle while receiving induction treatment. Two prescriptions are required, the first prescription for the loading dose at a dose no higher than 0.8mg per m<sup>2</sup>, and the second prescription for two doses at a dose no higher than 0.5mg per m<sup>2</sup>. Both prescriptions must be submitted with the initial application.</p> <p align=""justify"">Once a patient achieves complete remission or complete remission with partial haematological recovery, a new prescription must be written under the consolidation treatment phase.</p> <p align=""justify"">A complete remission is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a full recovery of peripheral blood counts with platelets of greater than 100,000 per microliter, and absolute neutrophil count (ANC) of greater than 1,000 per microliter.</p> <p align=""justify"">A complete remission with partial haematological recovery is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a partial recovery of peripheral blood counts with platelets of greater than 50,000 per microliter, and absolute neutrophil count (ANC) of greater than 500 per microliter.</p> <p align=""justify"">Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time when an assessment is required must cease PBS-subsidised therapy with this agent.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18219_18300_R","Initial treatment","AUTHORITY_REQUIRED","18300","18219","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>CD30 positive cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have pathologically confirmed CD30 positive cutaneous T-cell lymphoma; AND</p> <p>Patient must have CD30 positivity of at least 3% of malignant cells; AND</p> <p>Patient must have a diagnosis of mycosis fungoides; or</p> <p>Patient must have a diagnosis of Sezary syndrome; or</p> <p>Patient must have a diagnosis of primary cutaneous anaplastic large cell lymphoma; AND</p> <p>Patient must have received prior systemic treatment for this condition; AND</p> <p>The condition must be relapsed or refractory; AND</p> <p>The treatment must not exceed 4 cycles under this restriction in a lifetime; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of the histopathology report from an Approved Pathology Authority demonstrating the patient has a diagnosis of either mycosis fungoides, Sezary syndrome or primary cutaneous anaplastic large cell lymphoma; and</p><p align=""justify"">(b) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample or of a flow cytometric analysis of lymphoma cells of the blood showing CD30 positivity of at least 3% of malignant cells; and</p><p align=""justify"">(c) Date of commencement and completion of the most recent prior systemic treatment.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>CD30 positive cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have pathologically confirmed CD30 positive cutaneous T-cell lymphoma; AND</p> <p>Patient must have CD30 positivity of at least 3% of malignant cells; AND</p> <p>Patient must have a diagnosis of mycosis fungoides; or</p> <p>Patient must have a diagnosis of Sezary syndrome; or</p> <p>Patient must have a diagnosis of primary cutaneous anaplastic large cell lymphoma; AND</p> <p>Patient must have received prior systemic treatment for this condition; AND</p> <p>The condition must be relapsed or refractory; AND</p> <p>The treatment must not exceed 4 cycles under this restriction in a lifetime; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of the histopathology report from an Approved Pathology Authority demonstrating the patient has a diagnosis of either mycosis fungoides, Sezary syndrome or primary cutaneous anaplastic large cell lymphoma; and</p><p align=""justify"">(b) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample or of a flow cytometric analysis of lymphoma cells of the blood showing CD30 positivity of at least 3% of malignant cells; and</p><p align=""justify"">(c) Date of commencement and completion of the most recent prior systemic treatment.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18220_18301_R","Initial treatment","AUTHORITY_REQUIRED","18301","18220","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>CD30 positive peripheral T-cell lymphoma, non-cutaneous type</p><br/><p>Initial treatment</p><br/><p>Patient must have histological confirmation of CD30 expression in at least 3% of malignant cells; AND</p> <p>The treatment must be for first line therapy for this condition; AND</p> <p>The treatment must be for curative intent; AND</p> <p>The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND</p> <p>The treatment must not be more than 6 treatment cycles under this restriction in a lifetime.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample from an Approved Pathology Authority showing CD30 positivity of at least 3% malignant cells; and</p><p align=""justify"">(b) The date of initial diagnosis of Peripheral T-cell lymphoma.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>CD30 positive peripheral T-cell lymphoma, non-cutaneous type</p><br/><p>Initial treatment</p><br/><p>Patient must have histological confirmation of CD30 expression in at least 3% of malignant cells; AND</p> <p>The treatment must be for first line therapy for this condition; AND</p> <p>The treatment must be for curative intent; AND</p> <p>The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND</p> <p>The treatment must not be more than 6 treatment cycles under this restriction in a lifetime.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample from an Approved Pathology Authority showing CD30 positivity of at least 3% malignant cells; and</p><p align=""justify"">(b) The date of initial diagnosis of Peripheral T-cell lymphoma.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18221_18224_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","18224","18221","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must be undergoing continuing PBS-subsidised therapy with this drug where the most recent authority approval for this drug was for a different PBS indication to that stated above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication where the most recent authority approval was for a different growth hormone, (v) reclassify the PBS indication and recommence treatment simultaneously; AND</p> <p>The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must have had a height no higher than the 1st percentile for age plus sex at the time treatment first commenced; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; or</p> <p>Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where the patient had a chronological age greater than 2.5 years at commencement of treatment.</p><p align=""justify"">2. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">3. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must be undergoing continuing PBS-subsidised therapy with this drug where the most recent authority approval for this drug was for a different PBS indication to that stated above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication where the most recent authority approval was for a different growth hormone, (v) reclassify the PBS indication and recommence treatment simultaneously; AND</p> <p>The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must have had a height no higher than the 1st percentile for age plus sex at the time treatment first commenced; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; or</p> <p>Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where the patient had a chronological age greater than 2.5 years at commencement of treatment.</p><p align=""justify"">2. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">3. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18222_18446_R","Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements","AUTHORITY_REQUIRED","18446","18222","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application - subsidy through this treatment phase must only occur once per lifetime; AND</p> <p>The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must have had a height no higher than the 1st percentile for age plus sex at the time treatment first commenced; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; or</p> <p>Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment; OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age plus sex immediately prior to commencing treatment.</p><p align=""justify"">2. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">3. A bone age result performed within the last 12 months where the patient has chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application - subsidy through this treatment phase must only occur once per lifetime; AND</p> <p>The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must have had a height no higher than the 1st percentile for age plus sex at the time treatment first commenced; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; or</p> <p>Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment; OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age plus sex immediately prior to commencing treatment.</p><p align=""justify"">2. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">3. A bone age result performed within the last 12 months where the patient has chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18226_18372_R","Continuing treatment","STREAMLINED","18372","18226","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced carcinoma of the cervix</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this indication; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this indication; AND</p> <p>The treatment must not exceed a total of (i) 24 months, (ii) 35 doses (based on a 3-weekly dose regimen), (iii) 17 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless if it was PBS/non-PBS subsidised; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced carcinoma of the cervix</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this indication; AND</p> <p>The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this indication; AND</p> <p>The treatment must not exceed a total of (i) 24 months, (ii) 35 doses (based on a 3-weekly dose regimen), (iii) 17 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless if it was PBS/non-PBS subsidised; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18227_18452_R","Initial treatment","STREAMLINED","18452","18227","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx</p><br/><p>Initial treatment</p><br/><p>The condition must be incurable by local therapies in the locally advanced setting; AND</p> <p>Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have previously received programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy for any earlier stage of squamous cell carcinoma of the oral cavity, pharynx or larynx; AND</p> <p>Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if previously treated in the locally advanced setting; AND</p> <p>Patient must have had a WHO performance status of 0 or 1; AND</p> <p>The treatment must be either: (i) the sole PBS-subsidised therapy where the condition expresses programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx</p><br/><p>Initial treatment</p><br/><p>The condition must be incurable by local therapies in the locally advanced setting; AND</p> <p>Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have previously received programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy for any earlier stage of squamous cell carcinoma of the oral cavity, pharynx or larynx; AND</p> <p>Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if previously treated in the locally advanced setting; AND</p> <p>Patient must have had a WHO performance status of 0 or 1; AND</p> <p>The treatment must be either: (i) the sole PBS-subsidised therapy where the condition expresses programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p> <p align=""justify"">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18228_18373_R","Initial treatment - 3 weekly treatment regimen","STREAMLINED","18373","18228","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment - 3 weekly treatment regimen</p><br/><p>Patient must not have previously been treated for this condition in the metastatic setting; or</p> <p>The condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND</p> <p>The treatment must not exceed a total of 7 doses under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment - 3 weekly treatment regimen</p><br/><p>Patient must not have previously been treated for this condition in the metastatic setting; or</p> <p>The condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND</p> <p>The treatment must not exceed a total of 7 doses under this restriction.</p> <p align=""justify"">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18229_18229_R","null","STREAMLINED","18229","18229","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must have malignant neoplasia.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must have malignant neoplasia.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18230_18257_R","Initial treatment","STREAMLINED","18257","18230","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Extensive-stage small cell lung cancer</p><br/><p>Initial treatment</p><br/><p>The condition must be previously untreated; AND</p> <p>Patient must not have previously received programmed cell death-1/ligand-1 (PD-1/PD-L1) inhibitor therapy for any stage of small cell lung cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be in combination with etoposide and a platinum-based antineoplastic drug.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Extensive-stage small cell lung cancer</p><br/><p>Initial treatment</p><br/><p>The condition must be previously untreated; AND</p> <p>Patient must not have previously received programmed cell death-1/ligand-1 (PD-1/PD-L1) inhibitor therapy for any stage of small cell lung cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be in combination with etoposide and a platinum-based antineoplastic drug.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18233_18378_R","Initial treatment - Treatment refractory gMG patients","AUTHORITY_REQUIRED","18378","18233","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Initial treatment - Treatment refractory gMG patients</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must not have received treatment with a gMG biologic within 3 months prior to the first authority application for this indication (i.e. in treatment refractory setting); or</p> <p>Patient must be considered by the treating clinician to have deteriorating gMG disease during a treatment break with a gMG biological agent; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND</p> <p>The treatment must provide no more than 6 months of therapy per initial authority application; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Patients who are considered to have deteriorating gMG disease while on a treatment break with a gMG biologic may qualify with 9 months of remission inducing treatments (rather than 12 months).</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include:</p><p align=""justify"">(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];</p><p align=""justify"">(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessments were conducted).</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Initial treatment - Treatment refractory gMG patients</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must not have received treatment with a gMG biologic within 3 months prior to the first authority application for this indication (i.e. in treatment refractory setting); or</p> <p>Patient must be considered by the treating clinician to have deteriorating gMG disease during a treatment break with a gMG biological agent; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND</p> <p>The treatment must provide no more than 6 months of therapy per initial authority application; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Patients who are considered to have deteriorating gMG disease while on a treatment break with a gMG biologic may qualify with 9 months of remission inducing treatments (rather than 12 months).</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include:</p><p align=""justify"">(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];</p><p align=""justify"">(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessments were conducted).</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18234_18132_R","Loading dose","AUTHORITY_REQUIRED","18132","18234","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute severe generalised myasthenia gravis (gMG)</p><br/><p>Loading dose</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must be considered by the treating clinician to have rapidly deteriorating gMG disease in the absence of immediate treatment with a gMG biological agent; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must be commencing treatment with an NS-IST within 2 weeks; or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must be receiving concomitant treatment with an oral corticosteroid; AND</p> <p>Patient must not receive more than 3 months of total treatment with gMG biological agents under this PBS indication (''acute severe gMG''); AND</p> <p>Patient must not have accessed a prior PBS-subsidised gMG biological agent; or</p> <p>Patient must have developed an intolerance/toxicity to a PBS-subsidised gMG biological agent necessitating a change in treatment; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.</p><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute severe generalised myasthenia gravis (gMG)</p><br/><p>Loading dose</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must be considered by the treating clinician to have rapidly deteriorating gMG disease in the absence of immediate treatment with a gMG biological agent; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must be commencing treatment with an NS-IST within 2 weeks; or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must be receiving concomitant treatment with an oral corticosteroid; AND</p> <p>Patient must not receive more than 3 months of total treatment with gMG biological agents under this PBS indication (''acute severe gMG''); AND</p> <p>Patient must not have accessed a prior PBS-subsidised gMG biological agent; or</p> <p>Patient must have developed an intolerance/toxicity to a PBS-subsidised gMG biological agent necessitating a change in treatment; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.</p><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18235_18237_R","Initial treatment - Treatment refractory gMG patients (Loading dose)","AUTHORITY_REQUIRED","18237","18235","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Initial treatment - Treatment refractory gMG patients (Loading dose)</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must not have received treatment with a gMG biologic within 3 months prior to the first authority application for this indication (i.e. in treatment refractory setting); or</p> <p>Patient must be considered by the treating clinician to have deteriorating gMG disease during a treatment break with a gMG biological agent; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Patients who are considered to have deteriorating gMG disease while on a treatment break with a gMG biologic may qualify with 9 months of remission inducing treatments (rather than 12 months).</p> <p align=""justify"">Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.</p><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include:</p><p align=""justify"">(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];</p><p align=""justify"">(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessments were conducted).</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Initial treatment - Treatment refractory gMG patients (Loading dose)</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must not have received treatment with a gMG biologic within 3 months prior to the first authority application for this indication (i.e. in treatment refractory setting); or</p> <p>Patient must be considered by the treating clinician to have deteriorating gMG disease during a treatment break with a gMG biological agent; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Patients who are considered to have deteriorating gMG disease while on a treatment break with a gMG biologic may qualify with 9 months of remission inducing treatments (rather than 12 months).</p> <p align=""justify"">Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.</p><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include:</p><p align=""justify"">(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];</p><p align=""justify"">(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessments were conducted).</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18236_18133_R","Continuing treatment - Treatment refractory gMG patients (Loading dose)","AUTHORITY_REQUIRED","18133","18236","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Continuing treatment - Treatment refractory gMG patients (Loading dose)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a gMG biological agent for this PBS indication; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.</p><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include the MG-ADL and MGC scores assessed from the most recent course of treatment.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Continuing treatment - Treatment refractory gMG patients (Loading dose)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a gMG biological agent for this PBS indication; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Where loading doses of ravulizumab are required, additional authority prescriptions may be requested and approved in the same day.</p><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials for a single loading dose based on the patient&apos;s weight, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include the MG-ADL and MGC scores assessed from the most recent course of treatment.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18240_18425_R","Initial treatment","AUTHORITY_REQUIRED","18425","18240","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have received systemic treatment with chemotherapy; AND</p> <p>Patient must demonstrate relapsed or chemotherapy-refractory disease; AND</p> <p>Patient must be ineligible for stem cell transplant; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cutaneous T-cell lymphoma</p><br/><p>Initial treatment</p><br/><p>Patient must have received systemic treatment with chemotherapy; AND</p> <p>Patient must demonstrate relapsed or chemotherapy-refractory disease; AND</p> <p>Patient must be ineligible for stem cell transplant; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18245_18146_R","Initial treatment","AUTHORITY_REQUIRED","18146","18245","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to pathologic myopia (PM); AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to pathologic myopia (PM); AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18246_18499_R","Initial treatment - Initial 1 (New patient)","AUTHORITY_REQUIRED","18499","18246","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 1 (New patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.</p><p align=""justify"">State in the application whether a loading dose regimen is intended or not.</p><p align=""justify"">Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant &apos;Balance of supply&apos; listing.</p><p align=""justify"">Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""left"">The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The baseline BASDAI score and CRP level must also be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 1 (New patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.</p><p align=""justify"">State in the application whether a loading dose regimen is intended or not.</p><p align=""justify"">Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant &apos;Balance of supply&apos; listing.</p><p align=""justify"">Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""left"">The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The baseline BASDAI score and CRP level must also be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18248_18249_R","Initial treatment - Initial 1 (New patient)","AUTHORITY_REQUIRED","18249","18248","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 1 (New patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""left"">The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The baseline BASDAI score and CRP level must also be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 1 (New patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""left"">The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The baseline BASDAI score and CRP level must also be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18250_18251_R","Initial treatment","AUTHORITY_REQUIRED","18251","18250","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced basal cell carcinoma (BCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be inappropriate for surgery; AND</p> <p>The condition must be inappropriate for curative radiotherapy; AND</p> <p>Patient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition; or</p> <p>Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) Details (date, unique identifying number/code or provider number) of the histological confirmation of BCC and whether the condition is metastatic or locally advanced; and</p><p align=""justify"">(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that surgery is inappropriate; and</p><p align=""justify"">(c) In patients with locally advanced BCC, written confirmation from a radiation oncologist that curative radiotherapy is inappropriate.</p><p align=""justify"">The assessment of the patient&apos;s response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify""><b>Inappropriate for surgery is defined as:</b></p><p align=""justify"">(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or</p><p align=""justify"">(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or</p><p align=""justify"">(iii) Medical contraindication to surgery.</p><p align=""justify""><b>Inappropriate for curative radiotherapy is defined as:</b></p><p align=""justify"">(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or</p><p align=""justify"">(ii) Limitations due to location of tumour; or</p><p align=""justify"">(iii) Limitations due to cumulative prior radiotherapy dose; or</p><p align=""justify"">(iv) Progressive disease despite prior irradiation of locally advanced BCC.</p> <p align=""justify"">For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery and written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced basal cell carcinoma (BCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be inappropriate for surgery; AND</p> <p>The condition must be inappropriate for curative radiotherapy; AND</p> <p>Patient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition; or</p> <p>Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) Details (date, unique identifying number/code or provider number) of the histological confirmation of BCC and whether the condition is metastatic or locally advanced; and</p><p align=""justify"">(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that surgery is inappropriate; and</p><p align=""justify"">(c) In patients with locally advanced BCC, written confirmation from a radiation oncologist that curative radiotherapy is inappropriate.</p><p align=""justify"">The assessment of the patient&apos;s response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify""><b>Inappropriate for surgery is defined as:</b></p><p align=""justify"">(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or</p><p align=""justify"">(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or</p><p align=""justify"">(iii) Medical contraindication to surgery.</p><p align=""justify""><b>Inappropriate for curative radiotherapy is defined as:</b></p><p align=""justify"">(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or</p><p align=""justify"">(ii) Limitations due to location of tumour; or</p><p align=""justify"">(iii) Limitations due to cumulative prior radiotherapy dose; or</p><p align=""justify"">(iv) Progressive disease despite prior irradiation of locally advanced BCC.</p> <p align=""justify"">For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery and written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18254_18385_R","Initial treatment","AUTHORITY_REQUIRED","18385","18254","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion</p><br/><p>Initial treatment</p><br/><p>The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND</p> <p>The condition must be a mammary analogue secretory carcinoma of the salivary gland confirmed through a pathology report from an Approved Pathology Authority (of any date); or</p> <p>The condition must be a secretory breast carcinoma confirmed through a pathology report from an Approved Pathology Authority (of any date); AND</p> <p>The condition must be metastatic disease; or</p> <p>The condition must be both: (i) locally advanced, (ii) unresectable; or</p> <p>The condition must be both: (i) locally advanced, (ii) require disfiguring surgery/limb amputation to achieve complete surgical resection; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:</p><p align=""justify"">(a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date.</p><p align=""justify"">(b) details of the pathology report establishing the carcinoma type (salivary gland/secretory breast carcinoma) being treated, if different to the pathology report provided to substantiate the NTRK gene fusion.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion</p><br/><p>Initial treatment</p><br/><p>The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND</p> <p>The condition must be a mammary analogue secretory carcinoma of the salivary gland confirmed through a pathology report from an Approved Pathology Authority (of any date); or</p> <p>The condition must be a secretory breast carcinoma confirmed through a pathology report from an Approved Pathology Authority (of any date); AND</p> <p>The condition must be metastatic disease; or</p> <p>The condition must be both: (i) locally advanced, (ii) unresectable; or</p> <p>The condition must be both: (i) locally advanced, (ii) require disfiguring surgery/limb amputation to achieve complete surgical resection; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:</p><p align=""justify"">(a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date.</p><p align=""justify"">(b) details of the pathology report establishing the carcinoma type (salivary gland/secretory breast carcinoma) being treated, if different to the pathology report provided to substantiate the NTRK gene fusion.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18255_18386_R","Initial PBS-subsidised treatment for patients with T315I mutation","AUTHORITY_REQUIRED","18386","18255","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial PBS-subsidised treatment for patients with T315I mutation</p><br/><p>The condition must not be in the blast phase; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must have failed an adequate trial of at least one tyrosine kinase inhibitor as confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have experienced intolerance, not failure to respond, to at least one tyrosine kinase inhibitor as confirmed through a pathology report from an Approved Pathology Authority.</p> <p align=""justify"">Failure of an adequate trial of a tyrosine kinase inhibitor is defined as:</p><p align=""justify"">1. Lack of response defined as either:</p><p align=""justify"">(i) failure to achieve a haematological response after a minimum of 3 months therapy; or</p><p align=""justify"">(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive (Ph+) cells; or</p><p align=""justify"">(iii) failure to achieve or maintain a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy; OR</p><p align=""justify"">2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph+ cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy; OR</p><p align=""justify"">3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor (TKI) therapy; OR</p><p align=""justify"">4. Development of accelerated phase in a patient previously prescribed a TKI inhibitor for any phase of chronic myeloid leukaemia; OR</p><p align=""justify"">5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during TKI therapy in patients with accelerated phase chronic myeloid leukaemia.</p> <p/><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p/><p align=""justify"">2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or </p><p/><p align=""justify"">3. Peripheral basophils greater than or equal to 20%; or</p><p/><p align=""justify"">4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or </p><p/><p align=""justify"">5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).</p><p/> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or</p><p align=""justify"">(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and</p><p align=""justify"">(iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; and</p><p align=""justify"">(iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib, ponatinib or asciminib at any one time and must not be receiving concomitant interferon alfa therapy</p> <p align=""justify"">Up to a maximum of 18 months of treatment may be authorised under this initial restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Initial PBS-subsidised treatment for patients with T315I mutation</p><br/><p>The condition must not be in the blast phase; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report; AND</p> <p>The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or</p> <p>The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND</p> <p>Patient must have failed an adequate trial of at least one tyrosine kinase inhibitor as confirmed through a pathology report from an Approved Pathology Authority; or</p> <p>Patient must have experienced intolerance, not failure to respond, to at least one tyrosine kinase inhibitor as confirmed through a pathology report from an Approved Pathology Authority.</p> <p align=""justify"">Failure of an adequate trial of a tyrosine kinase inhibitor is defined as:</p><p align=""justify"">1. Lack of response defined as either:</p><p align=""justify"">(i) failure to achieve a haematological response after a minimum of 3 months therapy; or</p><p align=""justify"">(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive (Ph+) cells; or</p><p align=""justify"">(iii) failure to achieve or maintain a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy; OR</p><p align=""justify"">2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph+ cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy; OR</p><p align=""justify"">3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor (TKI) therapy; OR</p><p align=""justify"">4. Development of accelerated phase in a patient previously prescribed a TKI inhibitor for any phase of chronic myeloid leukaemia; OR</p><p align=""justify"">5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during TKI therapy in patients with accelerated phase chronic myeloid leukaemia.</p> <p/><p align=""justify"">Accelerated phase is defined by the presence of 1 or more of the following:</p><p/><p align=""justify"">1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or</p><p/><p align=""justify"">2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or </p><p/><p align=""justify"">3. Peripheral basophils greater than or equal to 20%; or</p><p/><p align=""justify"">4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or </p><p/><p align=""justify"">5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).</p><p/> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or</p><p align=""justify"">(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and</p><p align=""justify"">(iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; and</p><p align=""justify"">(iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib, ponatinib or asciminib at any one time and must not be receiving concomitant interferon alfa therapy</p> <p align=""justify"">Up to a maximum of 18 months of treatment may be authorised under this initial restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p> <p align=""justify"">Tyrosine Kinase Inhibitors (TKI) are defined as either (i) imatinib, (ii) dasatinib, (iii) nilotinib, (iv) ponatinib</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18256_18335_R","Initial treatment - Initial 1 (New patient)","AUTHORITY_REQUIRED","18335","18256","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 1 (New patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""left"">The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The baseline BASDAI score and CRP level must also be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 1 (New patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""left"">The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The baseline BASDAI score and CRP level must also be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18258_18461_R","null","STREAMLINED","18461","18258","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Patient must be symptomatic with NYHA classes II, III or IV; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance; AND</p> <p>Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Patient must be symptomatic with NYHA classes II, III or IV; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance; AND</p> <p>Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18259_18337_R","null","STREAMLINED","18337","18259","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be symptomatic with NYHA classes II, III or IV; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance; AND</p> <p>Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be symptomatic with NYHA classes II, III or IV; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance; AND</p> <p>Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18261_18155_R","Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements","AUTHORITY_REQUIRED","18155","18261","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements</p><br/><p>Patient must have previously received non-PBS-subsidised therapy with this drug for this condition; AND</p> <p>Patient must have met all other PBS eligibility criteria that a non-''Grandfather'' patient would ordinarily be required to meet, meaning that at the time non-PBS supply of a C5 inhibitor treatment was commenced, the patient: (i) had active and progressing thrombotic microangiopathy (TMA) caused by aHUS; (ii) had ADAMTS-13 activity of greater than or equal to 10% on a blood sample not confounded by any plasma exchange or infusion; (iii) had a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days of commencing C5 inhibitor treatment; (iv) had clinical features of active organ damage or impairment; AND</p> <p>Patient must have demonstrated ongoing treatment response with ravulizumab for this condition if received at least 26 weeks of initial non-PBS-subsidised therapy; AND</p> <p>Patient must not have experienced treatment failure with ravulizumab for this condition if they have received at least 26 weeks of initial non-PBS-subsidised therapy; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">Evidence of active and progressing TMA is defined by the following:</p><p align=""justify"">(1) A platelet count of less than 150x10^9/L; and evidence of at least two of the following:</p><p align=""justify"">(i) presence of schistocytes on blood film;</p><p align=""justify"">(ii) low or absent haptoglobin;</p><p align=""justify"">(iii) lactate dehydrogenase (LDH) above normal range; or</p><p align=""justify"">(2) In recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA; and</p><p align=""justify"">(3) Evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:</p><p align=""justify"">(a) kidney impairment as demonstrated by one or more of the following:</p><p align=""justify"">(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment;</p><p align=""justify"">(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment;</p><p align=""justify"">(iii) a sCr of greater than the age-appropriate ULN in paediatric patients;</p><p align=""justify"">(iv) a renal biopsy consistent with aHUS;</p><p align=""justify"">(b) onset of TMA-related neurological impairment;</p><p align=""justify"">(c) onset of TMA-related cardiac impairment;</p><p align=""justify"">(d) onset of TMA-related gastrointestinal impairment;</p><p align=""justify"">(e) onset of TMA-related pulmonary impairment.</p><p align=""justify"">Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised ravulizumab (where possible), and should be supported by objective clinical measures.</p><p align=""justify"">The prescriber&apos;s cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A detailed cover letter from the prescriber;</p><p align=""justify"">(4) A measurement of body weight at the time of application;</p><p align=""justify"">(5) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the two weeks prior to collection of the ADAMTS-13 assay;</p><p align=""justify"">(6) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days of initiating treatment with non-PBS-subsidised C5 inhibitor treatment;</p><p align=""justify"">(7) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within 4 weeks of commencement of non-PBS-subsidised C5 inhibitor treatment;</p><p align=""justify"">(8) For patients who have received at least 26 weeks of ravulizumab treatment, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical haemolytic uraemic syndrome (aHUS)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements</p><br/><p>Patient must have previously received non-PBS-subsidised therapy with this drug for this condition; AND</p> <p>Patient must have met all other PBS eligibility criteria that a non-''Grandfather'' patient would ordinarily be required to meet, meaning that at the time non-PBS supply of a C5 inhibitor treatment was commenced, the patient: (i) had active and progressing thrombotic microangiopathy (TMA) caused by aHUS; (ii) had ADAMTS-13 activity of greater than or equal to 10% on a blood sample not confounded by any plasma exchange or infusion; (iii) had a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days of commencing C5 inhibitor treatment; (iv) had clinical features of active organ damage or impairment; AND</p> <p>Patient must have demonstrated ongoing treatment response with ravulizumab for this condition if received at least 26 weeks of initial non-PBS-subsidised therapy; AND</p> <p>Patient must not have experienced treatment failure with ravulizumab for this condition if they have received at least 26 weeks of initial non-PBS-subsidised therapy; AND</p> <p>Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND</p> <p>Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.</p> <p align=""justify"">This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.</p> <p align=""justify"">Evidence of active and progressing TMA is defined by the following:</p><p align=""justify"">(1) A platelet count of less than 150x10^9/L; and evidence of at least two of the following:</p><p align=""justify"">(i) presence of schistocytes on blood film;</p><p align=""justify"">(ii) low or absent haptoglobin;</p><p align=""justify"">(iii) lactate dehydrogenase (LDH) above normal range; or</p><p align=""justify"">(2) In recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA; and</p><p align=""justify"">(3) Evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:</p><p align=""justify"">(a) kidney impairment as demonstrated by one or more of the following:</p><p align=""justify"">(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment;</p><p align=""justify"">(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment;</p><p align=""justify"">(iii) a sCr of greater than the age-appropriate ULN in paediatric patients;</p><p align=""justify"">(iv) a renal biopsy consistent with aHUS;</p><p align=""justify"">(b) onset of TMA-related neurological impairment;</p><p align=""justify"">(c) onset of TMA-related cardiac impairment;</p><p align=""justify"">(d) onset of TMA-related gastrointestinal impairment;</p><p align=""justify"">(e) onset of TMA-related pulmonary impairment.</p><p align=""justify"">Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised ravulizumab (where possible), and should be supported by objective clinical measures.</p><p align=""justify"">The prescriber&apos;s cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.</p> <p align=""justify"">Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.</p> <p align=""justify"">The authority application must be in writing and must include all of the following:</p><p align=""justify"">(1) Details of the proposed prescription(s);</p><p align=""justify"">(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);</p><p align=""justify"">(3) A detailed cover letter from the prescriber;</p><p align=""justify"">(4) A measurement of body weight at the time of application;</p><p align=""justify"">(5) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the two weeks prior to collection of the ADAMTS-13 assay;</p><p align=""justify"">(6) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days of initiating treatment with non-PBS-subsidised C5 inhibitor treatment;</p><p align=""justify"">(7) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within 4 weeks of commencement of non-PBS-subsidised C5 inhibitor treatment;</p><p align=""justify"">(8) For patients who have received at least 26 weeks of ravulizumab treatment, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for the balance of the current treatment phase. 8 weeks of treatment and up to 2 repeats according to the specified dosage in the approved Product Information (PI) may be sought.</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.</p> <p align=""justify"">The Authority application should be accompanied by a cover letter from the prescriber, providing complete details on:</p><p align=""justify"">a) Presenting clinical features, including history, acute treatment and medications;</p><p align=""justify"">b) Results of testing for genetic mutations (if available);</p><p align=""justify"">c) Family history of aHUS, especially in first-degree relatives;</p><p align=""justify"">d) Patient&apos;s prior history of episodes of active and progressing TMA caused by aHUS;</p><p align=""justify"">e) Exclusion of alternative causes of TMA;</p><p align=""justify"">f) History of renal or other organ transplant (if any);</p><p align=""justify"">g) Any other matters considered relevant by the prescriber.</p><p align=""justify"">In cases where there are discordant results (for example, an equivocal biopsy result in the absence of objective evidence of haemolysis) the cover letter should articulate the prescriber&apos;s interpretation of the clinical data and how a diagnosis of aHUS is supported by the available evidence.</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18265_18164_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","18164","18265","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.</p> <p>Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">Where the most recent course of PBS-subsidised treatment with this drug was approved under the first continuing treatment restriction, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.</p> <p>Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">Where the most recent course of PBS-subsidised treatment with this drug was approved under the first continuing treatment restriction, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18266_18391_R","Subsequent continuing treatment, Whole body","AUTHORITY_REQUIRED","18391","18266","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The most recent PASI assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The most recent PASI assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18270_18271_R","Continuing treatment","AUTHORITY_REQUIRED","18271","18270","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,</p><p align=""justify"">OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.</p> <p align=""justify"">All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.</p><p align=""justify"">The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient&apos;s response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.</p><p align=""justify"">A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) if applicable, details of maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) a completed Asthma Control Questionnaire (ACQ-5) score.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,</p><p align=""justify"">OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.</p> <p align=""justify"">All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.</p><p align=""justify"">The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient&apos;s response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.</p><p align=""justify"">A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) if applicable, details of maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) a completed Asthma Control Questionnaire (ACQ-5) score.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18277_18465_R","Initial treatment","AUTHORITY_REQUIRED","18465","18277","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic lupus erythematosus</p><br/><p>Initial treatment</p><br/><p>Patient must have a confirmed and documented diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) SLE Classification Criteria 2019; AND</p> <p>Patient must have persistent disease activity as supported by a SLE Disease Activity Index 2000 (SLEDAI-2K) score of at least 10 points; AND</p> <p>Patient must be currently receiving hydroxychloroquine, with treatment received for at least 12 weeks, unless contraindicated/intolerant necessitating treatment withdrawal; AND</p> <p>Patient must be currently receiving immunosuppressant medication, with treatment received for at least 12 weeks, with either: (i) minimum dose of methotrexate 20 mg per week, (ii) azathioprine 100 mg per day, (iii) mycophenolate 1,000 mg per day unless contraindicated/intolerant necessitating treatment withdrawal; AND</p> <p>Patient must be currently receiving prednisolone or equivalent of at least 7.5 mg per day, with treatment received for at least 4 weeks, unless contraindicated/intolerant necessitating treatment withdrawal; AND</p> <p>Patient must not have either: (i) severe active lupus nephritis, (ii) severe active central nervous system systemic lupus erythematosus; AND</p> <p>Must be treated by a specialist physician experienced in the management of this condition.</p> <p align=""left"">If prednisolone or equivalent is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated of at least 7.5 mg per day, the patient must have received at least 12 weeks of continuous treatment with each of at least 2 of the following: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day.</p><p align=""left"">Where two of: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; or (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to prednisolone or equivalent: at least one of the remaining tolerated therapies must be trialled at a minimum dose as mentioned above.</p><p align=""left"">If the patient has a contraindication/severe intolerance to each of: (i) prednisolone or equivalent of at least 7.5 mg per day; (ii) hydroxychloroquine; (iii) methotrexate at a dose of at least 20 mg per week; (iv) azathioprine at a dose of at least 100 mg per day; (v) mycophenolate at a dose of at least 1,000 mg per day; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application.</p> <p align=""justify"">The authority application must be made in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details of the ACR/EULAR SLE Classification Criteria 2019 confirming diagnosis of SLE;</p><p align=""justify"">(b) details (date and score) of the completed SLEDAI-2K score sheet;</p><p align=""justify"">(c) details of current systemic therapy used (dosage, date of commencement and duration of therapy including prior anifrolumab use);</p><p align=""justify"">(d) details of contraindication/intolerances to prior therapies (drug name, the degree of toxicity and dose).</p><p align=""justify"">All the reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Systemic lupus erythematosus</p><br/><p>Initial treatment</p><br/><p>Patient must have a confirmed and documented diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) SLE Classification Criteria 2019; AND</p> <p>Patient must have persistent disease activity as supported by a SLE Disease Activity Index 2000 (SLEDAI-2K) score of at least 10 points; AND</p> <p>Patient must be currently receiving hydroxychloroquine, with treatment received for at least 12 weeks, unless contraindicated/intolerant necessitating treatment withdrawal; AND</p> <p>Patient must be currently receiving immunosuppressant medication, with treatment received for at least 12 weeks, with either: (i) minimum dose of methotrexate 20 mg per week, (ii) azathioprine 100 mg per day, (iii) mycophenolate 1,000 mg per day unless contraindicated/intolerant necessitating treatment withdrawal; AND</p> <p>Patient must be currently receiving prednisolone or equivalent of at least 7.5 mg per day, with treatment received for at least 4 weeks, unless contraindicated/intolerant necessitating treatment withdrawal; AND</p> <p>Patient must not have either: (i) severe active lupus nephritis, (ii) severe active central nervous system systemic lupus erythematosus; AND</p> <p>Must be treated by a specialist physician experienced in the management of this condition.</p> <p align=""left"">If prednisolone or equivalent is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated of at least 7.5 mg per day, the patient must have received at least 12 weeks of continuous treatment with each of at least 2 of the following: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day.</p><p align=""left"">Where two of: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; or (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to prednisolone or equivalent: at least one of the remaining tolerated therapies must be trialled at a minimum dose as mentioned above.</p><p align=""left"">If the patient has a contraindication/severe intolerance to each of: (i) prednisolone or equivalent of at least 7.5 mg per day; (ii) hydroxychloroquine; (iii) methotrexate at a dose of at least 20 mg per week; (iv) azathioprine at a dose of at least 100 mg per day; (v) mycophenolate at a dose of at least 1,000 mg per day; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application.</p> <p align=""justify"">The authority application must be made in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details of the ACR/EULAR SLE Classification Criteria 2019 confirming diagnosis of SLE;</p><p align=""justify"">(b) details (date and score) of the completed SLEDAI-2K score sheet;</p><p align=""justify"">(c) details of current systemic therapy used (dosage, date of commencement and duration of therapy including prior anifrolumab use);</p><p align=""justify"">(d) details of contraindication/intolerances to prior therapies (drug name, the degree of toxicity and dose).</p><p align=""justify"">All the reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">SLEDAI-2K can be accessed via Gladman 2002 J. Rheumatol. 29 (2) 288-291 or from AstraZeneca Medical Information on 1800 805 342.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18278_18177_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","18177","18278","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p>At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p>At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18281_18282_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","18282","18281","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; or</p> <p>Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Active joints are defined as:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count must be no more than 4 weeks old at the time of this application.</p> <p>At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; or</p> <p>Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Active joints are defined as:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count must be no more than 4 weeks old at the time of this application.</p> <p>At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18286_18470_R","First continuing treatment, Whole body","AUTHORITY_REQUIRED","18470","18286","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18291_18196_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18196","18291","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; or</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine (adalimumab or infliximab) for this condition in this treatment cycle if aged 6 to 17 years; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; or</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle more than once if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient&apos;s condition if relevant; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.</p> <p>Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; or</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine (adalimumab or infliximab) for this condition in this treatment cycle if aged 6 to 17 years; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; or</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle more than once if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient&apos;s condition if relevant; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.</p> <p>Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18292_18197_R","Initial PBS-subsidised treatment with this drug in a child","AUTHORITY_REQUIRED","18197","18292","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Initial PBS-subsidised treatment with this drug in a child</p><br/><p>Patient must be of an age that is prior to their 19th birthday at the time of this authority application; AND</p> <p>Patient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rd birthday, but before their 19th birthday (SMA type IIIB/IIIC); AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing initial PBS-subsidised treatment with this drug for untreated disease; or</p> <p>Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access); AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:</p><p align=""justify"">(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,</p><p align=""justify"">(ii) Proximal weakness,</p><p align=""justify"">(iii) Hypotonia,</p><p align=""justify"">(iv) Absence of deep tendon reflexes,</p><p align=""justify"">(v) Any active denervation or chronic neurogenic changes found on electromyography,</p><p align=""justify"">(vi) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">In this authority application, confirm:</p><p align=""justify"">(1) the patient&apos;s medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy,</p><p align=""justify"">(2) which of the above (i to vi) (at least 1) were present after their 3<sup>rd</sup> birthday, but before their 19<sup>th</sup> birthday,</p><p align=""justify"">(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.</p> <p align=""justify"">The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant &apos;Note&apos; attached to this listing.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Initial PBS-subsidised treatment with this drug in a child</p><br/><p>Patient must be of an age that is prior to their 19th birthday at the time of this authority application; AND</p> <p>Patient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rd birthday, but before their 19th birthday (SMA type IIIB/IIIC); AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing initial PBS-subsidised treatment with this drug for untreated disease; or</p> <p>Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access); AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:</p><p align=""justify"">(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,</p><p align=""justify"">(ii) Proximal weakness,</p><p align=""justify"">(iii) Hypotonia,</p><p align=""justify"">(iv) Absence of deep tendon reflexes,</p><p align=""justify"">(v) Any active denervation or chronic neurogenic changes found on electromyography,</p><p align=""justify"">(vi) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">In this authority application, confirm:</p><p align=""justify"">(1) the patient&apos;s medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy,</p><p align=""justify"">(2) which of the above (i to vi) (at least 1) were present after their 3<sup>rd</sup> birthday, but before their 19<sup>th</sup> birthday,</p><p align=""justify"">(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.</p> <p align=""justify"">The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant &apos;Note&apos; attached to this listing.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18293_18356_R","Initial PBS-subsidised treatment with this drug in an adult who did not initiate PBS subsidy with this drug during childhood","AUTHORITY_REQUIRED","18356","18293","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Initial PBS-subsidised treatment with this drug in an adult who did not initiate PBS subsidy with this drug during childhood</p><br/><p>Patient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; AND</p> <p>Patient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19th birthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS-subsidised); AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing initial PBS-subsidised treatment with this drug for untreated disease; or</p> <p>Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access); AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:</p><p align=""justify"">(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,</p><p align=""justify"">(ii) Proximal weakness,</p><p align=""justify"">(iii) Hypotonia,</p><p align=""justify"">(iv) Absence of deep tendon reflexes,</p><p align=""justify"">(v) Failure to gain weight appropriate for age,</p><p align=""justify"">(vi) Any active denervation or chronic neurogenic changes found on electromyography,</p><p align=""justify"">(vii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">In this authority application, confirm:</p><p align=""justify"">(1) the patient&apos;s medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy,</p><p align=""justify"">(2) which of the above (i to vii) (at least 1) were present during childhood,</p><p align=""justify"">(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Initial PBS-subsidised treatment with this drug in an adult who did not initiate PBS subsidy with this drug during childhood</p><br/><p>Patient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; AND</p> <p>Patient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19th birthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS-subsidised); AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing initial PBS-subsidised treatment with this drug for untreated disease; or</p> <p>Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access); AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:</p><p align=""justify"">(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,</p><p align=""justify"">(ii) Proximal weakness,</p><p align=""justify"">(iii) Hypotonia,</p><p align=""justify"">(iv) Absence of deep tendon reflexes,</p><p align=""justify"">(v) Failure to gain weight appropriate for age,</p><p align=""justify"">(vi) Any active denervation or chronic neurogenic changes found on electromyography,</p><p align=""justify"">(vii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">In this authority application, confirm:</p><p align=""justify"">(1) the patient&apos;s medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy,</p><p align=""justify"">(2) which of the above (i to vii) (at least 1) were present during childhood,</p><p align=""justify"">(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18296_18209_R","Initial treatment - Second line treatment","AUTHORITY_REQUIRED","18209","18296","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe aplastic anaemia</p><br/><p>Initial treatment - Second line treatment</p><br/><p>The condition must be severe aplastic anaemia; AND</p> <p>Patient must not have achieved an adequate response to prior immunosuppressive therapy including anti-thymocyte antibody and ciclosporin; or</p> <p>Patient must have relapsed following prior immunosuppressive therapy including anti-thymocyte antibody and ciclosporin; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""justify"">The authority application must be made via the online PBS Authorities (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) prior immunosuppressive therapy, including dates of treatment.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe aplastic anaemia</p><br/><p>Initial treatment - Second line treatment</p><br/><p>The condition must be severe aplastic anaemia; AND</p> <p>Patient must not have achieved an adequate response to prior immunosuppressive therapy including anti-thymocyte antibody and ciclosporin; or</p> <p>Patient must have relapsed following prior immunosuppressive therapy including anti-thymocyte antibody and ciclosporin; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""justify"">The authority application must be made via the online PBS Authorities (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) prior immunosuppressive therapy, including dates of treatment.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18298_18210_R","Initial treatment - New patient","AUTHORITY_REQUIRED","18210","18298","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Initial treatment - New patient</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND</p> <p>Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;</p><p align=""justify"">(a) a platelet count of less than or equal to 20,000 million per L; OR</p><p align=""justify"">(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.</p> <p align=""justify"">The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details of a platelet count supporting the diagnosis of ITP.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Initial treatment - New patient</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND</p> <p>Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;</p><p align=""justify"">(a) a platelet count of less than or equal to 20,000 million per L; OR</p><p align=""justify"">(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.</p> <p align=""justify"">The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details of a platelet count supporting the diagnosis of ITP.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18299_18405_R","Initial treatment - New patient","AUTHORITY_REQUIRED","18405","18299","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Initial treatment - New patient</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND</p> <p>Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;</p><p align=""justify"">(a) a platelet count of less than or equal to 20,000 million per L; OR</p><p align=""justify"">(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.</p> <p align=""justify"">The medical practitioner should request 1 vial of the appropriate strength, to titrate therapy based on the weight of the patient. A maximum of 5 repeats will be authorised.</p> <p align=""justify"">Once a patient&apos;s dose has been stable for a period of 4 weeks, authority approvals for sufficient vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) for up to 4 weeks of treatment, may be requested under the Balance of supply or change of therapy restriction. The total period of treatment authorised under this restriction must not exceed 24 weeks.</p> <p align=""justify"">Authority approval will not be given for doses higher than 10 micrograms/kg/week</p> <p align=""justify"">The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details of a platelet count supporting the diagnosis of ITP.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Initial treatment - New patient</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND</p> <p>Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;</p><p align=""justify"">(a) a platelet count of less than or equal to 20,000 million per L; OR</p><p align=""justify"">(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.</p> <p align=""justify"">The medical practitioner should request 1 vial of the appropriate strength, to titrate therapy based on the weight of the patient. A maximum of 5 repeats will be authorised.</p> <p align=""justify"">Once a patient&apos;s dose has been stable for a period of 4 weeks, authority approvals for sufficient vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) for up to 4 weeks of treatment, may be requested under the Balance of supply or change of therapy restriction. The total period of treatment authorised under this restriction must not exceed 24 weeks.</p> <p align=""justify"">Authority approval will not be given for doses higher than 10 micrograms/kg/week</p> <p align=""justify"">The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details of a platelet count supporting the diagnosis of ITP.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18302_18449_R","Continuing treatment","AUTHORITY_REQUIRED","18449","18302","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Continuing treatment</p><br/><p>Patient must be undergoing continuing PBS-subsidised therapy with this drug - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication; AND</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age plus sex following the most recent supply; or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age plus sex following the most recent supply; or</p> <p>Patient must have achieved a minimum growth velocity of 4 cm per year following the most recent supply; or</p> <p>Patient must have achieved a mid-parental height standard deviation score following the most recent supply; or</p> <p>The treatment must have been administered at a dose that is lower than that recommended in the approved Product Information in the most recent supply; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""justify"">3. The final adult height (in cm) of the patient&apos;s mother and father (where available).</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Continuing treatment</p><br/><p>Patient must be undergoing continuing PBS-subsidised therapy with this drug - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication; AND</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age plus sex following the most recent supply; or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age plus sex following the most recent supply; or</p> <p>Patient must have achieved a minimum growth velocity of 4 cm per year following the most recent supply; or</p> <p>Patient must have achieved a mid-parental height standard deviation score following the most recent supply; or</p> <p>The treatment must have been administered at a dose that is lower than that recommended in the approved Product Information in the most recent supply; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""justify"">3. The final adult height (in cm) of the patient&apos;s mother and father (where available).</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18303_18445_R","Continuing treatment","AUTHORITY_REQUIRED","18445","18303","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Continuing treatment</p><br/><p>Patient must be undergoing continuing PBS-subsidised therapy with this drug - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication; AND</p> <p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age plus sex following the most recent supply; or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age plus sex following the most recent supply; or</p> <p>Patient must have achieved a minimum growth velocity of 4 cm per year following the most recent supply; or</p> <p>Patient must have achieved a mid-parental height standard deviation score following the most recent supply; or</p> <p>The treatment must have been administered at a dose that is lower than that recommended in the approved Product Information in the most recent supply; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""justify"">3. The final adult height (in cm) of the patient&apos;s mother and father (where available).</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Continuing treatment</p><br/><p>Patient must be undergoing continuing PBS-subsidised therapy with this drug - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication; AND</p> <p>Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND</p> <p>Patient must have achieved the 50th percentile growth velocity for bone age plus sex following the most recent supply; or</p> <p>Patient must have achieved an increase in height standard deviation score for chronological age plus sex following the most recent supply; or</p> <p>Patient must have achieved a minimum growth velocity of 4 cm per year following the most recent supply; or</p> <p>Patient must have achieved a mid-parental height standard deviation score following the most recent supply; or</p> <p>The treatment must have been administered at a dose that is lower than that recommended in the approved Product Information in the most recent supply; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""justify"">3. The final adult height (in cm) of the patient&apos;s mother and father (where available).</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18304_18477_R","Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements","AUTHORITY_REQUIRED","18477","18304","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application - subsidy through this treatment phase must only occur once per lifetime; AND</p> <p>The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age plus sex immediately prior to commencing treatment.</p><p align=""justify"">2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements</p><br/><p>Patient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application - subsidy through this treatment phase must only occur once per lifetime; AND</p> <p>The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age plus sex immediately prior to commencing treatment.</p><p align=""justify"">2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18305_18306_R","Continuing/maintenance treatment with this drug of either symptomatic Type I, II or IIIa SMA, or, pre-symptomatic SMA (1 or 2 copies of the SMN2 gene)","AUTHORITY_REQUIRED","18306","18305","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment with this drug of either symptomatic Type I, II or IIIa SMA, or, pre-symptomatic SMA (1 or 2 copies of the SMN2 gene)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; AND</p> <p>Patient must not be undergoing treatment through this ''Continuing treatment'' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy; AND</p> <p>Patient must have been 18 years of age or younger at the time of initial treatment with this drug; AND</p> <p>Patient must be 2 years of age or older, and weigh 20 kg or more.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment with this drug of either symptomatic Type I, II or IIIa SMA, or, pre-symptomatic SMA (1 or 2 copies of the SMN2 gene)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; AND</p> <p>Patient must not be undergoing treatment through this ''Continuing treatment'' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy; AND</p> <p>Patient must have been 18 years of age or younger at the time of initial treatment with this drug; AND</p> <p>Patient must be 2 years of age or older, and weigh 20 kg or more.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18309_18495_R","Subsequent PBS-prescriptions for any GLP-1 receptor agonist","STREAMLINED","18495","18309","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>Subsequent PBS-prescriptions for any GLP-1 receptor agonist</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment for type 2 diabetes mellitus with any of: an SGLT2 inhibitor, a DPP4 inhibitor, another GLP-1 receptor agonist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diabetes mellitus type 2</p><br/><p>Subsequent PBS-prescriptions for any GLP-1 receptor agonist</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must not be undergoing concomitant PBS-subsidised treatment for type 2 diabetes mellitus with any of: an SGLT2 inhibitor, a DPP4 inhibitor, another GLP-1 receptor agonist.</p> <p align=""justify"">Abbreviations used in the restriction are as follows:</p><p align=""justify"">SGLT2 - sodium glucose co-transporter-2 inhibitor (drug names ending in &apos;flozin&apos;)</p><p align=""justify"">DPP4 - dipeptidyl peptidase-4 inhibitor (drug names ending in &apos;gliptin&apos;)</p><p align=""justify"">GLP-1 - glucagon-like peptide-1 receptor agonist</p> <p align=""justify"">Where an SGLT2 inhibitor is being accessed through a PBS indication other than diabetes, the clinical criterion excluding concomitant treatment with an SGLT2 inhibitor is in relation to diabetes mellitus type 2 only.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18311_18453_R","Initial treatment - 6 weekly treatment regimen","STREAMLINED","18453","18311","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment - 6 weekly treatment regimen</p><br/><p>Patient must not have previously been treated for this condition in the metastatic setting; or</p> <p>The condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND</p> <p>The treatment must not exceed a total of 4 doses under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment - 6 weekly treatment regimen</p><br/><p>Patient must not have previously been treated for this condition in the metastatic setting; or</p> <p>The condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND</p> <p>The treatment must not exceed a total of 4 doses under this restriction.</p> <p align=""justify"">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18312_18312_R","null","STREAMLINED","18312","18312","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; AND</p> <p>The condition must be unresponsive to other oral therapies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; AND</p> <p>The condition must be unresponsive to other oral therapies.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18313_18313_R","null","STREAMLINED","18313","18313","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be receiving palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18314_18314_R","null","STREAMLINED","18314","18314","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18315_18481_R","null","STREAMLINED","18481","18315","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Limited-stage small cell lung cancer</p><br/><p>Patient must have received chemoradiation therapy (CRT); AND</p> <p>The condition must not have progressed following CRT; AND</p> <p>Patient must have had a WHO performance status of no greater than 1 at treatment initiation with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>The treatment must not exceed 24 months in total for this condition, measured from the initial dose, or must not extend beyond disease progression, whichever comes first.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Limited-stage small cell lung cancer</p><br/><p>Patient must have received chemoradiation therapy (CRT); AND</p> <p>The condition must not have progressed following CRT; AND</p> <p>Patient must have had a WHO performance status of no greater than 1 at treatment initiation with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>The treatment must not exceed 24 months in total for this condition, measured from the initial dose, or must not extend beyond disease progression, whichever comes first.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18317_18128_R","Transitioning from non-PBS to PBS-subsidised treatment - Grandfathering treatment - Treatment refractory gMG patients","AUTHORITY_REQUIRED","18128","18317","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfathering treatment - Treatment refractory gMG patients</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 April 2026; AND</p> <p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must have had a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND</p> <p>The treatment must provide no more than 6 months of therapy under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include:</p><p align=""justify"">(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];</p><p align=""justify"">(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessment was conducted);</p><p align=""justify"">(c) the MG-ADL and MGC scores assessed from the most recent course of treatment demonstrating clinical improvement to treatment (include the date the assessment was conducted).</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A retrospective assessment for one of the MGC score or MG-ADL score after completing the 12 months remission inducing treatments can be accepted for grandfathered patients in cases where it was not conducted prior to commencing non-PBS-subsidised treatment for this indication.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfathering treatment - Treatment refractory gMG patients</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 April 2026; AND</p> <p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must have had a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND</p> <p>The treatment must provide no more than 6 months of therapy under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include:</p><p align=""justify"">(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];</p><p align=""justify"">(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessment was conducted);</p><p align=""justify"">(c) the MG-ADL and MGC scores assessed from the most recent course of treatment demonstrating clinical improvement to treatment (include the date the assessment was conducted).</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A retrospective assessment for one of the MGC score or MG-ADL score after completing the 12 months remission inducing treatments can be accepted for grandfathered patients in cases where it was not conducted prior to commencing non-PBS-subsidised treatment for this indication.</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18318_18129_R","Continuing treatment - Treatment refractory gMG patients","AUTHORITY_REQUIRED","18129","18318","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Continuing treatment - Treatment refractory gMG patients</p><br/><p>Patient must have previously received PBS-subsidised treatment with a gMG biological agent for this PBS indication; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>The treatment must provide no more than 6 months of therapy per continuing authority application; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include the MG-ADL and MGC scores assessed from the most recent course of treatment.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Continuing treatment - Treatment refractory gMG patients</p><br/><p>Patient must have previously received PBS-subsidised treatment with a gMG biological agent for this PBS indication; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>The treatment must provide no more than 6 months of therapy per continuing authority application; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include the MG-ADL and MGC scores assessed from the most recent course of treatment.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18320_18320_R","Initial 3: New patient (transitioning from PBS-subsidised lanadelumab)","AUTHORITY_REQUIRED","18320","18320","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 3: New patient (transitioning from PBS-subsidised lanadelumab)</p><br/><p>Patient must have been receiving lanadelumab through the PBS as routine prophylaxis for hereditary angioedema immediately prior to receiving this drug; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 3: New patient (transitioning from PBS-subsidised lanadelumab)</p><br/><p>Patient must have been receiving lanadelumab through the PBS as routine prophylaxis for hereditary angioedema immediately prior to receiving this drug; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18321_18321_R","Continuing preventative treatment","AUTHORITY_REQUIRED","18321","18321","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Continuing preventative treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab; AND</p> <p>Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.</p> <p align=""justify"">For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient&apos;s medical records for auditing purposes.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Continuing preventative treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab; AND</p> <p>Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.</p> <p align=""justify"">For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient&apos;s medical records for auditing purposes.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18322_18498_R","Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis)","AUTHORITY_REQUIRED","18498","18322","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis)</p><br/><p>Patient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment with this drug; AND</p> <p>Patient must not have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema at the time of application; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate</p> <p align=""justify"">The baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating treatment must be provided at the time of submitting this application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis)</p><br/><p>Patient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment with this drug; AND</p> <p>Patient must not have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema at the time of application; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate</p> <p align=""justify"">The baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating treatment must be provided at the time of submitting this application.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18323_13246_R","Continuing treatment","AUTHORITY_REQUIRED","13246","18323","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cutaneous T-cell lymphoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18324_18324_R","Continuing treatment","STREAMLINED","18324","18324","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk and intermediate-2 risk myelofibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk and intermediate-2 risk myelofibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18325_18455_R","Initial treatment - 3 weekly treatment regimen","STREAMLINED","18455","18325","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment - 3 weekly treatment regimen</p><br/><p>Patient must not have previously been treated for this condition in the metastatic setting; or</p> <p>The condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND</p> <p>The treatment must not exceed a total of 7 doses under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment - 3 weekly treatment regimen</p><br/><p>Patient must not have previously been treated for this condition in the metastatic setting; or</p> <p>The condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND</p> <p>The treatment must not exceed a total of 7 doses under this restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18327_18244_R","Initial treatment","AUTHORITY_REQUIRED","18244","18327","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18328_18147_R","Initial treatment","AUTHORITY_REQUIRED","18147","18328","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must not be due to pathologic myopia; AND</p> <p>The condition must not be due to age-related macular degeneration; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must not be due to pathologic myopia; AND</p> <p>The condition must not be due to age-related macular degeneration; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18330_18247_R","First PBS-subsidised prescription for this drug","AUTHORITY_REQUIRED","18247","18330","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Transthyretin amyloid cardiomyopathy</p><br/><p>First PBS-subsidised prescription for this drug</p><br/><p>The condition must have documented evidence of transthyretin precursor protein present; AND</p> <p>Patient must have experienced at least one episode of hospitalisation that was a direct result of heart failure; or</p> <p>Patient must have clinical evidence of heart failure without hospitalisation that required treatment with a diuretic for improvement; AND</p> <p>Patient must have/have had New York Heart Association class I heart failure at the time of commencing this drug; or</p> <p>Patient must have/have had New York Heart Association class II heart failure at the time of commencing this drug; AND</p> <p>Patient must have an end-diastolic interventricular septal wall thickness of at least 12 mm on imaging; AND</p> <p>Patient must have an estimated glomerular filtration rate (eGFR) greater than 25 mL/minute/1.73 m2; AND</p> <p>Must be treated by a medical practitioner who is any of the following: (i) a cardiologist, (ii) a consultant physician with experience in the management of amyloid disorders; this authority application must be sought by the same medical practitioner providing treatment.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Evidence of clinical findings to establish the diagnosis:</p><p align=""justify"">In this authority application, confirm that there is documented evidence of transthyretin precursor protein through either (1) alone, or, both (2) and (3), from the list below:</p><p align=""justify"">Confirm the following has been completed:</p><p align=""justify"">(1) amyloid expert centre histology findings derived via immunohistochemistry or mass spectrometry; OR</p><p align=""justify"">(2) bone scintigraphy with grade 2-3 finding</p><p align=""justify"">AND</p><p align=""justify"">(3) Confirm that there are negative results for monoclonal protein on each of the following three tests:</p><p align=""justify"">(a) serum immunofixation (also known as protein electrophoresis)</p><p align=""justify"">(b) urine immunofixation</p><p align=""justify"">(c) serum free light chains blood test</p><p align=""justify"">State which of (1) to (3) above has been completed, as well as the:</p><p align=""justify"">(i) date of the finding,</p><p align=""justify"">(ii) imaging/pathology report number/code that links the finding to the patient,</p><p align=""justify"">(iii) name of the amyloid expert centre in this authority application (if applicable)<i>.</i></p><p align=""justify"">For end-diastolic interventricular septal wall thickness (at least 12 mm), confirm that:</p><p align=""justify"">(i) imaging (echocardiogram or magnetic resonance imaging) has been undertaken; and</p><p align=""justify"">(ii) that the imaging report is stored in the patient&apos;s medical records.</p><p align=""justify"">State the date that the imaging was performed and the thickness (in mm) in this authority application.</p> <p align=""justify"">Where this authority application is to transition a patient from non-PBS-subsidised to PBS-subsidised supply (i.e. a &apos;grandfathered&apos; patient), confirm the following:</p><p align=""justify"">(i) the patient&apos;s heart failure has not worsened to persistent New York Heart Association Class III/IV heart failure while taking this drug.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Transthyretin amyloid cardiomyopathy</p><br/><p>First PBS-subsidised prescription for this drug</p><br/><p>The condition must have documented evidence of transthyretin precursor protein present; AND</p> <p>Patient must have experienced at least one episode of hospitalisation that was a direct result of heart failure; or</p> <p>Patient must have clinical evidence of heart failure without hospitalisation that required treatment with a diuretic for improvement; AND</p> <p>Patient must have/have had New York Heart Association class I heart failure at the time of commencing this drug; or</p> <p>Patient must have/have had New York Heart Association class II heart failure at the time of commencing this drug; AND</p> <p>Patient must have an end-diastolic interventricular septal wall thickness of at least 12 mm on imaging; AND</p> <p>Patient must have an estimated glomerular filtration rate (eGFR) greater than 25 mL/minute/1.73 m2; AND</p> <p>Must be treated by a medical practitioner who is any of the following: (i) a cardiologist, (ii) a consultant physician with experience in the management of amyloid disorders; this authority application must be sought by the same medical practitioner providing treatment.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Evidence of clinical findings to establish the diagnosis:</p><p align=""justify"">In this authority application, confirm that there is documented evidence of transthyretin precursor protein through either (1) alone, or, both (2) and (3), from the list below:</p><p align=""justify"">Confirm the following has been completed:</p><p align=""justify"">(1) amyloid expert centre histology findings derived via immunohistochemistry or mass spectrometry; OR</p><p align=""justify"">(2) bone scintigraphy with grade 2-3 finding</p><p align=""justify"">AND</p><p align=""justify"">(3) Confirm that there are negative results for monoclonal protein on each of the following three tests:</p><p align=""justify"">(a) serum immunofixation (also known as protein electrophoresis)</p><p align=""justify"">(b) urine immunofixation</p><p align=""justify"">(c) serum free light chains blood test</p><p align=""justify"">State which of (1) to (3) above has been completed, as well as the:</p><p align=""justify"">(i) date of the finding,</p><p align=""justify"">(ii) imaging/pathology report number/code that links the finding to the patient,</p><p align=""justify"">(iii) name of the amyloid expert centre in this authority application (if applicable)<i>.</i></p><p align=""justify"">For end-diastolic interventricular septal wall thickness (at least 12 mm), confirm that:</p><p align=""justify"">(i) imaging (echocardiogram or magnetic resonance imaging) has been undertaken; and</p><p align=""justify"">(ii) that the imaging report is stored in the patient&apos;s medical records.</p><p align=""justify"">State the date that the imaging was performed and the thickness (in mm) in this authority application.</p> <p align=""justify"">Where this authority application is to transition a patient from non-PBS-subsidised to PBS-subsidised supply (i.e. a &apos;grandfathered&apos; patient), confirm the following:</p><p align=""justify"">(i) the patient&apos;s heart failure has not worsened to persistent New York Heart Association Class III/IV heart failure while taking this drug.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p> <p align=""justify"">The Australian Amyloid Network provides a list of clinic centres that manage amyloidosis. It also provides a list of Australian anatomical pathology laboratories to be contacted for tissue review and immunohistochemistry for amyloid typing. For the purposes of this restriction, these providers are considered to be amyloid expert centres.</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18331_18144_R","Initial treatment","AUTHORITY_REQUIRED","18144","18331","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Branch retinal vein occlusion with macular oedema</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Branch retinal vein occlusion with macular oedema</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18332_18384_R","Initial treatment","AUTHORITY_REQUIRED","18384","18332","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solid tumours (of any type) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion where treatment with this drug is/was initiated in a child</p><br/><p>Initial treatment</p><br/><p>The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND</p> <p>The condition must be metastatic disease; or</p> <p>The condition must be both: (i) locally advanced, (ii) unresectable; or</p> <p>The condition must be both: (i) locally advanced, (ii) require disfiguring surgery/limb amputation to achieve complete surgical resection; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition; AND</p> <p>Patient must be/have been under 18 years of age (i.e. prior to their 18th birthday) at treatment initiation with this drug.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:</p><p align=""justify"">(a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solid tumours (of any type) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion where treatment with this drug is/was initiated in a child</p><br/><p>Initial treatment</p><br/><p>The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND</p> <p>The condition must be metastatic disease; or</p> <p>The condition must be both: (i) locally advanced, (ii) unresectable; or</p> <p>The condition must be both: (i) locally advanced, (ii) require disfiguring surgery/limb amputation to achieve complete surgical resection; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition; AND</p> <p>Patient must be/have been under 18 years of age (i.e. prior to their 18th birthday) at treatment initiation with this drug.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:</p><p align=""justify"">(a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18339_18150_R","null","STREAMLINED","18150","18339","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Patient must be symptomatic with NYHA classes II, III or IV; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance; AND</p> <p>Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must not be co-administered with an ACE inhibitor or an angiotensin II antagonist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Patient must be symptomatic with NYHA classes II, III or IV; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance; AND</p> <p>Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must not be co-administered with an ACE inhibitor or an angiotensin II antagonist.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18341_18431_R","Subsequent continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","18431","18341","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The most recent PASI assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The most recent PASI assessment must be no more than 1 month old at the time of application.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18342_18343_R","First continuing treatment","AUTHORITY_REQUIRED","18343","18342","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p>Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p>Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18344_18165_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","18165","18344","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18347_18180_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","18180","18347","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.</p> <p/><p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p/><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either </p><p/><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p/><p align=""justify"">(b) at least 4 active joints from the following list:</p><p/><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p/><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p><p/><p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. </p><p/><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p>At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An assessment of a patient&apos;s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.</p> <p/><p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p/><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either </p><p/><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p/><p align=""justify"">(b) at least 4 active joints from the following list:</p><p/><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p/><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p><p/><p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. </p><p/><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p>At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">An assessment of a patient&apos;s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p/><p align=""justify"">The Department of Human Services website (www.humanservices.gov.au) has details of the toxicities, including severity, which will be accepted for the following purposes:</p><p/><p align=""justify"">(a) exempting a patient from the requirement to undertake a minimum 3 month trial of methotrexate at a 20 mg weekly dose; </p><p/><p align=""justify"">(b) substituting azathioprine, cyclosporin or sodium aurothiomalate for another DMARD as part of the 6 month intensive DMARD trial;</p><p/><p align=""justify"">(c) exempting a patient from the requirement for a 6 month trial of intensive DMARD therapy. </p><p/> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18349_18280_R","Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilzumab after resolution of the critical shortage of tocilizumab)","AUTHORITY_REQUIRED","18280","18349","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilzumab after resolution of the critical shortage of tocilizumab)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.</p> <p align=""justify"">If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p>At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilzumab after resolution of the critical shortage of tocilizumab)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.</p> <p align=""justify"">If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p>At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, and etanercept for patients over 18 years who have a history of juvenile idiopathic arthritis with onset prior to the age of 18 years.</p><p align=""justify"">This listing is a temporary listing and is only to be used to transfer patients currently receiving PBS-subsidised treatment with tocilizumab to another biological medicine, where tocilizumab is not available due to the current critical medicines shortage.</p><p align=""justify"">Alternative biological medicine refers to adalimumab and etanercept.</p><p align=""justify"">Should it be necessary to continue treatment with the alternative biological medicine, applications must be made under the relevant &apos;First continuing - Temporary listing&apos; PBS listing.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18354_18192_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18192","18354","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18358_18359_R","Continuing treatment","AUTHORITY_REQUIRED","18359","18358","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe growth failure with primary insulin-like growth factor-1 deficiency</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have a bone age of less than 13.5 years (females); or</p> <p>Patient must have a bone age of less than 15.5 years (males); AND</p> <p>The treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing); AND</p> <p>The condition must be responsive to this drug treatment as evidenced by each of: (i) patient is showing catch-up for height standard deviation score against Laron syndrome (growth hormone insensitivity syndrome) growth charts, (ii) patient has a growth velocity of greater than 2 cm per year (extrapolated for time on treatment) at the time of this continuing authority application; or</p> <p>The condition must be yet to respond to this drug treatment only for the reason of sub-optimal dosing; AND</p> <p>Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type; or</p> <p>Must be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician; AND</p> <p>Patient must be aged from 2 years up until their 18th birthday.</p> <p align=""justify"">The continuing treatment authority application must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) The patient&apos;s height (cm);</p><p align=""justify"">(2) Where this authority application seeks to continue treatment where there has been an inadequate response to treatment due to sub-optimal dosing, state each of:</p><p align=""justify"">(i) the most recently prescribed dose (mg/kg) that resulted in an inadequate response;</p><p align=""justify"">(ii) the dose (mg/kg) (between 0.04 to 0.12) that was/will be subsequently prescribed to address the inadequate response;</p><p align=""justify"">(3) The patient&apos;s weight (kg);</p><p align=""justify"">(4) The patient&apos;s growth velocity in response to the preceding supply of drug (cm/year; extrapolated for time on treatment);</p><p align=""justify"">(5) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant &apos;NOTE&apos; attached to this listing for guidance.</p><p align=""justify"">Height, growth velocity and weight measurements must not be more than three months old at the time of application.</p><p align=""justify"">Document growth improvements in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe growth failure with primary insulin-like growth factor-1 deficiency</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have a bone age of less than 13.5 years (females); or</p> <p>Patient must have a bone age of less than 15.5 years (males); AND</p> <p>The treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing); AND</p> <p>The condition must be responsive to this drug treatment as evidenced by each of: (i) patient is showing catch-up for height standard deviation score against Laron syndrome (growth hormone insensitivity syndrome) growth charts, (ii) patient has a growth velocity of greater than 2 cm per year (extrapolated for time on treatment) at the time of this continuing authority application; or</p> <p>The condition must be yet to respond to this drug treatment only for the reason of sub-optimal dosing; AND</p> <p>Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type; or</p> <p>Must be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician; AND</p> <p>Patient must be aged from 2 years up until their 18th birthday.</p> <p align=""justify"">The continuing treatment authority application must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) The patient&apos;s height (cm);</p><p align=""justify"">(2) Where this authority application seeks to continue treatment where there has been an inadequate response to treatment due to sub-optimal dosing, state each of:</p><p align=""justify"">(i) the most recently prescribed dose (mg/kg) that resulted in an inadequate response;</p><p align=""justify"">(ii) the dose (mg/kg) (between 0.04 to 0.12) that was/will be subsequently prescribed to address the inadequate response;</p><p align=""justify"">(3) The patient&apos;s weight (kg);</p><p align=""justify"">(4) The patient&apos;s growth velocity in response to the preceding supply of drug (cm/year; extrapolated for time on treatment);</p><p align=""justify"">(5) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant &apos;NOTE&apos; attached to this listing for guidance.</p><p align=""justify"">Height, growth velocity and weight measurements must not be more than three months old at the time of application.</p><p align=""justify"">Document growth improvements in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS authority application administrator will approve a maximum quantity of vials in line with the following formula (based on the upper dose range of 0.12 mg/kg dosed twice daily, one vial containing 40 mg of drug and target supply duration of 30 days per dispensing):</p><p align=""justify"">Number of vials equals 7.2 multiplied by weight (kg) divided by 40. For ease of reference, this equates to:</p><p align=""justify"">Below 16 kg: up to 3 vials</p><p align=""justify"">16 to 22 kg: up to 4 vials</p><p align=""justify"">22 to 27 kg: up to 5 vials</p><p align=""justify"">27 to 33 kg: up to 6 vials</p><p align=""justify"">33 to 38 kg: up to 7 vials</p><p align=""justify"">38 to 44 kg: up to 8 vials</p><p align=""justify"">Beyond 44 kg: refer to above formula</p> <p align=""justify"">Laron syndrome growth charts are those appearing in the following publication:</p><p align=""justify"">Laron Z, Lilos P, Klinger B. Growth Curves for Laron syndrome. <i>Arch Dis Child</i>. 1993;68(6):768-770.</p><p align=""justify"">This literature article can be accessed through the following website link:</p><p align=""justify"">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1029371</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18360_18217_R","Recommencement of treatment","AUTHORITY_REQUIRED","18217","18360","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Recommencement of treatment</p><br/><p>Patient must be undergoing recommencing treatment following a temporary treatment break (i.e. a lapse) from this drug for the stated indication above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not be for the purposes of resuming treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Recent growth data (height and weight, not older than three months).</p><p align=""justify"">2. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Recommencement of treatment</p><br/><p>Patient must be undergoing recommencing treatment following a temporary treatment break (i.e. a lapse) from this drug for the stated indication above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not be for the purposes of resuming treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Recent growth data (height and weight, not older than three months).</p><p align=""justify"">2. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18361_18367_R","Recommencement of treatment","AUTHORITY_REQUIRED","18367","18361","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Recommencement of treatment</p><br/><p>Patient must be undergoing recommencing treatment following a temporary treatment break (i.e. a lapse) from this drug for the stated indication above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not be for the purposes of resuming treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Recent growth data (height and weight, not older than three months).</p><p align=""justify"">2. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Recommencement of treatment</p><br/><p>Patient must be undergoing recommencing treatment following a temporary treatment break (i.e. a lapse) from this drug for the stated indication above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not be for the purposes of resuming treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Recent growth data (height and weight, not older than three months).</p><p align=""justify"">2. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p> <p align=""justify"">If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for<i> recommencement of treatment as a reclassified patient </i>should be submitted<i>.</i></p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18362_18447_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","18447","18362","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must be undergoing treatment that is simultaneously: (a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must have had a height no higher than the 1st percentile for age plus sex at the time treatment first commenced; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; or</p> <p>Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""left"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""left"">1. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where the patient had a chronological age greater than 2.5 years at commencement of treatment.</p><p align=""left"">2. Recent growth data (height and weight, not older than three months).</p><p align=""left"">3. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must be undergoing treatment that is simultaneously: (a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must have had a height no higher than the 1st percentile for age plus sex at the time treatment first commenced; AND</p> <p>Patient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; or</p> <p>Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""left"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""left"">1. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where the patient had a chronological age greater than 2.5 years at commencement of treatment.</p><p align=""left"">2. Recent growth data (height and weight, not older than three months).</p><p align=""left"">3. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18365_18444_R","Change of drug","AUTHORITY_REQUIRED","18444","18365","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Change of drug</p><br/><p>Patient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication; AND</p> <p>Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Definition:</p><p align=""justify"">An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:</p><p align=""justify"">(a) the 50<sup>th</sup> percentile growth velocity for bone age;</p><p align=""justify"">(b) an increase in height standard deviation score for chronological age;</p><p align=""justify"">(c) a minimum growth velocity of 4 cm per year;</p><p align=""justify"">(d) a mid-parental height standard deviation score.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""justify"">Where growth data has been supplied within 3 months of this authority application, do not resupply this data.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Change of drug</p><br/><p>Patient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication; AND</p> <p>Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Definition:</p><p align=""justify"">An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:</p><p align=""justify"">(a) the 50<sup>th</sup> percentile growth velocity for bone age;</p><p align=""justify"">(b) an increase in height standard deviation score for chronological age;</p><p align=""justify"">(c) a minimum growth velocity of 4 cm per year;</p><p align=""justify"">(d) a mid-parental height standard deviation score.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""justify"">Where growth data has been supplied within 3 months of this authority application, do not resupply this data.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18366_18363_R","Recommencement of treatment as a reclassified patient","AUTHORITY_REQUIRED","18363","18366","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must be undergoing treatment that is simultaneously: (a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age plus sex immediately prior to commencing treatment.</p><p align=""justify"">2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Recommencement of treatment as a reclassified patient</p><br/><p>Patient must be undergoing treatment that is simultaneously: (a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone; AND</p> <p>Patient must have had a lapse in growth hormone treatment; AND</p> <p>The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age plus sex immediately prior to commencing treatment.</p><p align=""justify"">2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18368_18411_R","Change of drug","AUTHORITY_REQUIRED","18411","18368","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Change of drug</p><br/><p>Patient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication; AND</p> <p>Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Definition:</p><p align=""justify"">An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:</p><p align=""justify"">(a) the 50<sup>th</sup> percentile growth velocity for bone age;</p><p align=""justify"">(b) an increase in height standard deviation score for chronological age;</p><p align=""justify"">(c) a minimum growth velocity of 4 cm per year;</p><p align=""justify"">(d) a mid-parental height standard deviation score.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""justify"">Where growth data has been supplied within 3 months of this authority application, do not resupply this data.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Change of drug</p><br/><p>Patient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication; AND</p> <p>Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; or</p> <p>Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0cm; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">Definition:</p><p align=""justify"">An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:</p><p align=""justify"">(a) the 50<sup>th</sup> percentile growth velocity for bone age;</p><p align=""justify"">(b) an increase in height standard deviation score for chronological age;</p><p align=""justify"">(c) a minimum growth velocity of 4 cm per year;</p><p align=""justify"">(d) a mid-parental height standard deviation score.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""justify"">Where growth data has been supplied within 3 months of this authority application, do not resupply this data.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18369_18369_R","Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhood","AUTHORITY_REQUIRED","18369","18369","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhood</p><br/><p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must be undergoing continuation of existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated prior to the patient''s 19th birthday for SMA type IIIB/IIIC; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>Patient must be 2 years of age or older, and weigh 20 kg or more.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhood</p><br/><p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must be undergoing continuation of existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated prior to the patient''s 19th birthday for SMA type IIIB/IIIC; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>Patient must be 2 years of age or older, and weigh 20 kg or more.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18370_18370_R","null","STREAMLINED","18370","18370","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urothelial carcinoma</p><br/><p>The treatment must be for each of: (i) adjuvant therapy that is/was initiated within 6 months of radical surgical resection, (ii) muscle invasive type disease, (iii) disease considered to be at high risk of recurrence based on pathologic staging of radical surgery tissue (ypT2-ypT4a or ypN+), but yet to recur, (iv) use as the sole PBS-subsidised anti-cancer treatment for this condition; AND</p> <p>Patient must have received prior platinum containing neoadjuvant chemotherapy; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND</p> <p>Patient must be undergoing treatment with a dosing regimen as set out in the drug''s Therapeutic Goods Administration (TGA) approved Product Information; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words ''cancelled'' where (i)/(ii) has occurred.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">An increase in repeat prescriptions, up to a value of 11, may only be sought where the prescribed dosing is 240 mg administered fortnightly.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urothelial carcinoma</p><br/><p>The treatment must be for each of: (i) adjuvant therapy that is/was initiated within 6 months of radical surgical resection, (ii) muscle invasive type disease, (iii) disease considered to be at high risk of recurrence based on pathologic staging of radical surgery tissue (ypT2-ypT4a or ypN+), but yet to recur, (iv) use as the sole PBS-subsidised anti-cancer treatment for this condition; AND</p> <p>Patient must have received prior platinum containing neoadjuvant chemotherapy; AND</p> <p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND</p> <p>Patient must be undergoing treatment with a dosing regimen as set out in the drug''s Therapeutic Goods Administration (TGA) approved Product Information; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words ''cancelled'' where (i)/(ii) has occurred.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">An increase in repeat prescriptions, up to a value of 11, may only be sought where the prescribed dosing is 240 mg administered fortnightly.</p>","N","N","N","IMMEDIATE","ALL","Y","2026-04-01","N","4708"
"18371_18371_R","Initial treatment","STREAMLINED","18371","18371","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk locally advanced carcinoma of the cervix</p><br/><p>Initial treatment</p><br/><p>Patient must have high-risk, locally advanced cervical cancer of one of the following types: (i) squamous cell carcinoma, (ii) adenosquamous carcinoma, (iii) adenocarcinoma; AND</p> <p>The treatment must be/have been commenced in combination with concurrent chemoradiotherapy; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must not have received prior PBS-subsidised treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for carcinoma of the cervix; AND</p> <p>The treatment must not exceed a total of (i) 24 months, (ii) 35 doses (based on a 3-weekly dose regimen), (iii) 17 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless if it was PBS/non-PBS subsidised; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk locally advanced carcinoma of the cervix</p><br/><p>Initial treatment</p><br/><p>Patient must have high-risk, locally advanced cervical cancer of one of the following types: (i) squamous cell carcinoma, (ii) adenosquamous carcinoma, (iii) adenocarcinoma; AND</p> <p>The treatment must be/have been commenced in combination with concurrent chemoradiotherapy; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must not have received prior PBS-subsidised treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for carcinoma of the cervix; AND</p> <p>The treatment must not exceed a total of (i) 24 months, (ii) 35 doses (based on a 3-weekly dose regimen), (iii) 17 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless if it was PBS/non-PBS subsidised; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18374_18374_R","null","STREAMLINED","18374","18374","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic constipation</p><br/><p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic constipation</p><br/><p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18375_18375_R","null","STREAMLINED","18375","18375","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; AND</p> <p>The condition must be unresponsive to other oral therapies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; AND</p> <p>The condition must be unresponsive to other oral therapies.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18376_18376_R","null","STREAMLINED","18376","18376","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Faecal impaction</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Faecal impaction</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18379_18137_R","Transitioning from non-PBS to PBS-subsidised treatment - Grandfathering treatment","AUTHORITY_REQUIRED","18137","18379","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfathering treatment</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 March 2026; AND</p> <p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must have had a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND</p> <p>The treatment must provide no more than 6 months of therapy under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include:</p><p align=""justify"">(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];</p><p align=""justify"">(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessment was conducted);</p><p align=""justify"">(c) the MG-ADL and MGC scores assessed from the most recent course of treatment demonstrating clinical improvement to treatment (include the date the assessment was conducted).</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A retrospective assessment for one of the MGC score or MG-ADL score after completing the 12 months remission inducing treatments can be accepted for grandfathered patients in cases where it was not conducted prior to commencing non-PBS-subsidised treatment for this indication.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfathering treatment</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 March 2026; AND</p> <p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must have had a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND</p> <p>The treatment must provide no more than 6 months of therapy under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include:</p><p align=""justify"">(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];</p><p align=""justify"">(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessment was conducted);</p><p align=""justify"">(c) the MG-ADL and MGC scores assessed from the most recent course of treatment demonstrating clinical improvement to treatment (include the date the assessment was conducted).</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A retrospective assessment for one of the MGC score or MG-ADL score after completing the 12 months remission inducing treatments can be accepted for grandfathered patients in cases where it was not conducted prior to commencing non-PBS-subsidised treatment for this indication.</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18380_18135_R","Non-loading/maintenance doses","AUTHORITY_REQUIRED","18135","18380","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bridging therapy for generalised myasthenia gravis (gMG)</p><br/><p>Non-loading/maintenance doses</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must be receiving concomitant treatment with an oral corticosteroid; AND</p> <p>Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for 3 months; (ii) oral corticosteroids for 3 months; (iii) a thymectomy; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must not receive more than 6 months of bridging treatment with any gMG biological agent under this PBS indication; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient dose of the drug, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing and must include:</p><p align=""justify"">(a) the MG-ADL and MGC score after 3-months of remission-inducing treatments (include the date the assessments were conducted);</p><p align=""justify"">(b) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy].</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A retrospective assessment for one of the MGC score or MG-ADL score can be accepted in cases where it was not conducted after completing 3 months of remission inducing treatments.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bridging therapy for generalised myasthenia gravis (gMG)</p><br/><p>Non-loading/maintenance doses</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must be receiving concomitant treatment with an oral corticosteroid; AND</p> <p>Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for 3 months; (ii) oral corticosteroids for 3 months; (iii) a thymectomy; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must not receive more than 6 months of bridging treatment with any gMG biological agent under this PBS indication; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient dose of the drug, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing and must include:</p><p align=""justify"">(a) the MG-ADL and MGC score after 3-months of remission-inducing treatments (include the date the assessments were conducted);</p><p align=""justify"">(b) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy].</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A retrospective assessment for one of the MGC score or MG-ADL score can be accepted in cases where it was not conducted after completing 3 months of remission inducing treatments.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18381_18500_R","Continuing treatment","AUTHORITY_REQUIRED","18500","18381","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced basal cell carcinoma (BCC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must remain inappropriate for surgery; AND</p> <p>The condition must remain inappropriate for curative radiotherapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) Confirmation from the treating doctor that the disease has not progressed; and</p><p align=""justify"">(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that the condition remains inappropriate for surgery; or written confirmation from a radiation oncologist that the condition remains inappropriate for curative radiotherapy.</p><p align=""justify"">The assessment of the patient&apos;s response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify""><b>Inappropriate for surgery is defined as:</b></p><p align=""justify"">(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or</p><p align=""justify"">(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or</p><p align=""justify"">(iii) Medical contraindication to surgery.</p><p align=""justify""><b>Inappropriate for curative radiotherapy is defined as:</b></p><p align=""justify"">(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or</p><p align=""justify"">(ii) Limitations due to location of tumour; or</p><p align=""justify"">(iii) Limitations due to cumulative prior radiotherapy dose; or</p><p align=""justify"">(iv) Progressive disease despite prior irradiation of locally advanced BCC.</p> <p align=""justify"">For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced basal cell carcinoma (BCC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must remain inappropriate for surgery; AND</p> <p>The condition must remain inappropriate for curative radiotherapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) Confirmation from the treating doctor that the disease has not progressed; and</p><p align=""justify"">(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that the condition remains inappropriate for surgery; or written confirmation from a radiation oncologist that the condition remains inappropriate for curative radiotherapy.</p><p align=""justify"">The assessment of the patient&apos;s response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify""><b>Inappropriate for surgery is defined as:</b></p><p align=""justify"">(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or</p><p align=""justify"">(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or</p><p align=""justify"">(iii) Medical contraindication to surgery.</p><p align=""justify""><b>Inappropriate for curative radiotherapy is defined as:</b></p><p align=""justify"">(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or</p><p align=""justify"">(ii) Limitations due to location of tumour; or</p><p align=""justify"">(iii) Limitations due to cumulative prior radiotherapy dose; or</p><p align=""justify"">(iv) Progressive disease despite prior irradiation of locally advanced BCC.</p> <p align=""justify"">For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18382_18383_R","Initial treatment","AUTHORITY_REQUIRED","18383","18382","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>The treatment must be in combination with capecitabine; AND</p> <p>Patient must have received prior therapy with a taxane for at least 3 cycles; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; or</p> <p>Patient must have developed intolerance to treatment with a taxane of a severity necessitating permanent treatment withdrawal; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; or</p> <p>Patient must have experienced disease progression following treatment with trastuzumab emtansine in whom disease had relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; or</p> <p>Patient must have experienced disease relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; AND</p> <p>The treatment must be the sole PBS-subsidised anti-HER2 therapy for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH); and</p><p align=""justify"">(ii) date of last treatment with a taxane and total number of cycles; or</p><p align=""justify"">(iii) dates of treatment with trastuzumab and pertuzumab; or</p><p align=""justify"">(iv) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab and pertuzumab; or</p><p align=""justify"">(v) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab</p><p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND</p> <p>The treatment must be in combination with capecitabine; AND</p> <p>Patient must have received prior therapy with a taxane for at least 3 cycles; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; or</p> <p>Patient must have developed intolerance to treatment with a taxane of a severity necessitating permanent treatment withdrawal; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; or</p> <p>Patient must have experienced disease progression following treatment with trastuzumab emtansine in whom disease had relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; or</p> <p>Patient must have experienced disease relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; AND</p> <p>The treatment must be the sole PBS-subsidised anti-HER2 therapy for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH); and</p><p align=""justify"">(ii) date of last treatment with a taxane and total number of cycles; or</p><p align=""justify"">(iii) dates of treatment with trastuzumab and pertuzumab; or</p><p align=""justify"">(iv) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab and pertuzumab; or</p><p align=""justify"">(v) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab</p><p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18387_18429_R","Initial treatment - Initial 1 (New patient)","AUTHORITY_REQUIRED","18429","18387","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 1 (New patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""left"">The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The baseline BASDAI score and CRP level must also be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Initial treatment - Initial 1 (New patient)</p><br/><p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND</p> <p>Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND</p> <p>Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND</p> <p>The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND</p> <p>The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND</p> <p>The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND</p> <p>The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND</p> <p>The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND</p> <p>The treatment must not exceed a maximum of 16 weeks with this drug under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align=""justify"">The application must include details of the NSAIDs trialled, their doses and duration of treatment.</p><p align=""justify"">If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.</p><p align=""justify"">If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.</p><p align=""justify"">If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:</p><p align=""justify"">(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and</p><p align=""justify"">(b) C-reactive protein (CRP) level greater than 10 mg per L.</p><p align=""left"">The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""left"">If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The baseline BASDAI score and CRP level must also be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18388_18388_R","Continuing treatment","AUTHORITY_REQUIRED","18388","18388","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of Acute Hepatic Porphyria (AHP)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must demonstrate improvement in the frequency or severity of AHP attacks from baseline while on treatment with this drug; AND</p> <p>Must be treated by a healthcare professional experienced in the management of porphyria or in consultation with a healthcare professional experienced in the management of porphyria; AND</p> <p>Patient must not have previously undergone a liver transplant; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">The number of AHP attacks while on treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of the authority application, prescribers should request the appropriate number of vials for a single dose based on the patient&apos;s weight, as per the TGA-approved Product Information.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of Acute Hepatic Porphyria (AHP)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must demonstrate improvement in the frequency or severity of AHP attacks from baseline while on treatment with this drug; AND</p> <p>Must be treated by a healthcare professional experienced in the management of porphyria or in consultation with a healthcare professional experienced in the management of porphyria; AND</p> <p>Patient must not have previously undergone a liver transplant; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">The number of AHP attacks while on treatment must be documented in the patient&apos;s medical records.</p> <p align=""justify"">At the time of the authority application, prescribers should request the appropriate number of vials for a single dose based on the patient&apos;s weight, as per the TGA-approved Product Information.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18390_18264_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","18264","18390","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed Crohn Disease Activity Index (CDAI) Score; or</p><p align=""justify"">(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and</p><p align=""justify"">(iii) the date of the most recent clinical assessment.</p> <p align=""justify"">All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.</p> <p align=""justify"">Each application for subsequent continuing treatment with this drug must include an assessment of the patient&apos;s response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or</p> <p>Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Applications for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed Crohn Disease Activity Index (CDAI) Score; or</p><p align=""justify"">(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and</p><p align=""justify"">(iii) the date of the most recent clinical assessment.</p> <p align=""justify"">All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.</p> <p align=""justify"">Each application for subsequent continuing treatment with this drug must include an assessment of the patient&apos;s response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18392_18269_R","Continuing treatment","AUTHORITY_REQUIRED","18269","18392","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,</p><p align=""justify"">OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.</p> <p align=""justify"">All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and, for the application for continuing therapy to be processed.</p><p align=""justify"">The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient&apos;s response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.</p><p align=""justify"">A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.</p> <p align=""justify"">A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) if applicable, details of maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) a completed Asthma Control Questionnaire (ACQ-5) score.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,</p><p align=""justify"">OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.</p> <p align=""justify"">All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and, for the application for continuing therapy to be processed.</p><p align=""justify"">The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient&apos;s response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.</p><p align=""justify"">A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.</p> <p align=""justify"">A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) if applicable, details of maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) a completed Asthma Control Questionnaire (ACQ-5) score.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18393_18346_R","First continuing treatment","AUTHORITY_REQUIRED","18346","18393","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18394_18284_R","Initial treatment","AUTHORITY_REQUIRED","18284","18394","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic rhinosinusitis with nasal polyps (CRSwNP)</p><br/><p>Initial treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP; AND</p> <p>Patient must have a diagnosis of CRSwNP confirmed by at least one of: (i) nasal endoscopy, (ii) computed tomography (CT) scan, with the results documented in the patient''s medical records; or</p> <p>Patient must have a diagnosis of CRSwNP from at least two physicians of the above mentioned prescriber types; AND</p> <p>Patient must have undergone surgery for the removal of nasal polyps; or</p> <p>Patient must have the written advice from at least two physicians of the above mentioned prescriber types demonstrating inappropriateness for surgery; AND</p> <p>Patient must have, despite optimised nasal polyp therapy, at least two of: (i) bilateral endoscopic nasal polyp score of at least 5 (out of a maximum score of 8, with a minimum score of 2 in each nasal cavity), (ii) nasal obstruction visual analogue scale (VAS) score greater than 5 (out of a maximum score of 10), (iii) overall symptom VAS score greater than 7 (out of a maximum score of 10); AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have had a 12 month break in PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND</p> <p>Patient must have failed to achieve adequate control with optimised nasal polyp therapy which has been documented; AND</p> <p>Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Optimised nasal polyp therapy includes:</p><p align=""justify"">(a) adherence to intranasal corticosteroid therapy for at least 2 months, unless contraindicated or not tolerated</p><p align=""justify"">(b) if required, nasal irrigation with saline</p><p align=""justify"">Where the patient has a contraindication or intolerance to intranasal corticosteroid therapy, document the reasons for the contraindication or intolerance in the patient&apos;s medical file.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription,</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice),</p><p align=""justify"">(c) details (date of commencement and duration of therapy) of prior optimised nasal polyp medicine treatment,</p><p align=""justify"">(d) details (date and treatment) of nasal polyp surgery; or</p><p align=""justify"">(e) if applicable, details of surgical exception including serious comorbid disease (e.g. cardiovascular, stroke) making the risk of surgery unacceptable,</p><p align=""justify"">(f) the eosinophil count and date,</p><p align=""justify"">(g) two of the following, measured within the past 12 months: (i) baseline bilateral endoscopic nasal polyp score, (ii) baseline nasal obstruction VAS score, (iii) baseline overall VAS score.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic rhinosinusitis with nasal polyps (CRSwNP)</p><br/><p>Initial treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP; AND</p> <p>Patient must have a diagnosis of CRSwNP confirmed by at least one of: (i) nasal endoscopy, (ii) computed tomography (CT) scan, with the results documented in the patient''s medical records; or</p> <p>Patient must have a diagnosis of CRSwNP from at least two physicians of the above mentioned prescriber types; AND</p> <p>Patient must have undergone surgery for the removal of nasal polyps; or</p> <p>Patient must have the written advice from at least two physicians of the above mentioned prescriber types demonstrating inappropriateness for surgery; AND</p> <p>Patient must have, despite optimised nasal polyp therapy, at least two of: (i) bilateral endoscopic nasal polyp score of at least 5 (out of a maximum score of 8, with a minimum score of 2 in each nasal cavity), (ii) nasal obstruction visual analogue scale (VAS) score greater than 5 (out of a maximum score of 10), (iii) overall symptom VAS score greater than 7 (out of a maximum score of 10); AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have had a 12 month break in PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND</p> <p>Patient must have failed to achieve adequate control with optimised nasal polyp therapy which has been documented; AND</p> <p>Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Optimised nasal polyp therapy includes:</p><p align=""justify"">(a) adherence to intranasal corticosteroid therapy for at least 2 months, unless contraindicated or not tolerated</p><p align=""justify"">(b) if required, nasal irrigation with saline</p><p align=""justify"">Where the patient has a contraindication or intolerance to intranasal corticosteroid therapy, document the reasons for the contraindication or intolerance in the patient&apos;s medical file.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription,</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice),</p><p align=""justify"">(c) details (date of commencement and duration of therapy) of prior optimised nasal polyp medicine treatment,</p><p align=""justify"">(d) details (date and treatment) of nasal polyp surgery; or</p><p align=""justify"">(e) if applicable, details of surgical exception including serious comorbid disease (e.g. cardiovascular, stroke) making the risk of surgery unacceptable,</p><p align=""justify"">(f) the eosinophil count and date,</p><p align=""justify"">(g) two of the following, measured within the past 12 months: (i) baseline bilateral endoscopic nasal polyp score, (ii) baseline nasal obstruction VAS score, (iii) baseline overall VAS score.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18395_18287_R","Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18287","18395","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""left"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""left"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18396_18352_R","Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18352","18396","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""left"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""left"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18399_18355_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18355","18399","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); or</p> <p>Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; or</p> <p>Patient must have previously received induction therapy with this drug for an acute severe episode of ulcerative colitis in the last 4 months and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a PUCAI score less than 10 (if aged 6 to 17 years); AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""left"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8-weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application.</p> <p align=""left"">Where treatment for an acute severe episode has occurred, an adequate response to induction therapy needs to be demonstrated by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 (if aged 6 to 17 years), within the first 12 weeks of receiving this drug for acute severe ulcerative colitis.</p> <p align=""justify"">A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient&apos;s response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); or</p> <p>Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; or</p> <p>Patient must have previously received induction therapy with this drug for an acute severe episode of ulcerative colitis in the last 4 months and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a PUCAI score less than 10 (if aged 6 to 17 years); AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""left"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8-weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application.</p> <p align=""left"">Where treatment for an acute severe episode has occurred, an adequate response to induction therapy needs to be demonstrated by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 (if aged 6 to 17 years), within the first 12 weeks of receiving this drug for acute severe ulcerative colitis.</p> <p align=""justify"">A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient&apos;s response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">The assessment of the patient&apos;s response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18402_18294_R","Initial 1 - starting combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient","AUTHORITY_REQUIRED","18294","18402","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 - starting combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 - starting combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18404_18297_R","Initial treatment - New patient","AUTHORITY_REQUIRED","18297","18404","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Initial treatment - New patient</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND</p> <p>Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;</p><p align=""justify"">(a) a platelet count of less than or equal to 20,000 million per L; OR</p><p align=""justify"">(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.</p> <p align=""justify"">The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details of a platelet count supporting the diagnosis of ITP.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe thrombocytopenia</p><br/><p>Initial treatment - New patient</p><br/><p>The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND</p> <p>Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND</p> <p>Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND</p> <p>The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;</p><p align=""justify"">(a) a platelet count of less than or equal to 20,000 million per L; OR</p><p align=""justify"">(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.</p> <p align=""justify"">The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details of a platelet count supporting the diagnosis of ITP.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">A maximum of 24 weeks of treatment with this drug will be authorised under this criterion.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18407_18503_R","Initial treatment","AUTHORITY_REQUIRED","18503","18407","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>CD30 positive systemic anaplastic large cell lymphoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be for curative intent; AND</p> <p>Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND</p> <p>Patient must demonstrate relapsed or chemotherapy-refractory disease; AND</p> <p>Patient must have responded to PBS-subsidised treatment with this drug if previously used for initial treatment of CD30 positive peripheral T-cell lymphoma, non-cutaneous type; AND</p> <p>The treatment must not exceed 4 cycles under this restriction.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number or provider number) of a histology report showing evidence of the tumour&apos;s CD30 positivity; and</p><p align=""justify"">(b) The date of initial diagnosis of systemic anaplastic large cell lymphoma; and</p><p align=""justify"">(c) Dates of commencement and completion of front-line curative intent chemotherapy; and</p><p align=""justify"">(d) a declaration of whether the patient&apos;s disease is relapsed or refractory, and the date and means by which the patient&apos;s disease was assessed as being relapsed or refractory.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>CD30 positive systemic anaplastic large cell lymphoma</p><br/><p>Initial treatment</p><br/><p>The treatment must be for curative intent; AND</p> <p>Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND</p> <p>Patient must demonstrate relapsed or chemotherapy-refractory disease; AND</p> <p>Patient must have responded to PBS-subsidised treatment with this drug if previously used for initial treatment of CD30 positive peripheral T-cell lymphoma, non-cutaneous type; AND</p> <p>The treatment must not exceed 4 cycles under this restriction.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number or provider number) of a histology report showing evidence of the tumour&apos;s CD30 positivity; and</p><p align=""justify"">(b) The date of initial diagnosis of systemic anaplastic large cell lymphoma; and</p><p align=""justify"">(c) Dates of commencement and completion of front-line curative intent chemotherapy; and</p><p align=""justify"">(d) a declaration of whether the patient&apos;s disease is relapsed or refractory, and the date and means by which the patient&apos;s disease was assessed as being relapsed or refractory.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18408_18410_R","Initial treatment","AUTHORITY_REQUIRED","18410","18408","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Initial treatment</p><br/><p>Patient must have a current height at or below the 1st percentile for age and sex; AND</p> <p>Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 160.1 cm; or</p> <p>Patient must be female and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 148.0 cm; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""left"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""left"">1. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application.</p><p align=""left"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""left"">3. Confirmation of the patient&apos;s maturational or constitutional delay status.</p><p align=""left"">4. If the patient has maturational or constitutional delay, confirmation that the patient has an estimated mature height below the 1<sup>st</sup> adult height percentile.<br/><br/></p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature and slow growth</p><br/><p>Initial treatment</p><br/><p>Patient must have a current height at or below the 1st percentile for age and sex; AND</p> <p>Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Patient must be male and must not have a height greater than or equal to 167.7 cm; or</p> <p>Patient must be female and must not have a height greater than or equal to 155.0 cm; AND</p> <p>Patient must be male and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 160.1 cm; or</p> <p>Patient must be female and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 148.0 cm; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""left"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""left"">1. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application.</p><p align=""left"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""left"">3. Confirmation of the patient&apos;s maturational or constitutional delay status.</p><p align=""left"">4. If the patient has maturational or constitutional delay, confirmation that the patient has an estimated mature height below the 1<sup>st</sup> adult height percentile.<br/><br/></p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18412_18307_R","Initial treatment","AUTHORITY_REQUIRED","18307","18412","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)</p><br/><p>Initial treatment</p><br/><p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; AND</p> <p>Patient must be between 2 and 18 years of age and weigh 20 kg or more.</p> <p align=""justify"">Defined signs and symptoms of type I SMA are:</p><p align=""justify"">i) Onset before 6 months of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Defined signs and symptoms of type II SMA are:</p><p align=""justify"">i) Onset between 6 and 18 months; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Weakness in trunk righting/derotation; or</p><p align=""justify"">v) Hypotonia; or</p><p align=""justify"">vi) Absence of deep tendon reflexes; or</p><p align=""justify"">vii) Failure to gain weight appropriate for age; or</p><p align=""justify"">viii) Any active chronic neurogenic changes; or</p><p align=""justify"">ix) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Defined signs and symptoms of type IIIa SMA are:</p><p align=""justify"">i) Onset between 18 months and 3 years of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) specification of SMA type (I, II or IIIa); and</p><p align=""justify"">(ii) sign(s) and symptom(s) that the patient has experienced; and</p><p align=""justify"">(iii) patient&apos;s age at the onset of sign(s) and symptom(s).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)</p><br/><p>Initial treatment</p><br/><p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Patient must not have received PBS-subsidised gene therapy; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; AND</p> <p>Patient must be between 2 and 18 years of age and weigh 20 kg or more.</p> <p align=""justify"">Defined signs and symptoms of type I SMA are:</p><p align=""justify"">i) Onset before 6 months of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Defined signs and symptoms of type II SMA are:</p><p align=""justify"">i) Onset between 6 and 18 months; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Weakness in trunk righting/derotation; or</p><p align=""justify"">v) Hypotonia; or</p><p align=""justify"">vi) Absence of deep tendon reflexes; or</p><p align=""justify"">vii) Failure to gain weight appropriate for age; or</p><p align=""justify"">viii) Any active chronic neurogenic changes; or</p><p align=""justify"">ix) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Defined signs and symptoms of type IIIa SMA are:</p><p align=""justify"">i) Onset between 18 months and 3 years of age; and</p><p align=""justify"">ii) Failure to meet or regression in ability to perform age-appropriate motor milestones; or</p><p align=""justify"">iii) Proximal weakness; or</p><p align=""justify"">iv) Hypotonia; or</p><p align=""justify"">v) Absence of deep tendon reflexes; or</p><p align=""justify"">vi) Failure to gain weight appropriate for age; or</p><p align=""justify"">vii) Any active chronic neurogenic changes; or</p><p align=""justify"">viii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:</p><p align=""justify"">(i) specification of SMA type (I, II or IIIa); and</p><p align=""justify"">(ii) sign(s) and symptom(s) that the patient has experienced; and</p><p align=""justify"">(iii) patient&apos;s age at the onset of sign(s) and symptom(s).</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18413_18413_R","null","STREAMLINED","18413","18413","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resectable locally advanced squamous cell carcinoma of the oral cavity, pharynx or larynx</p><br/><p>Patient must have stage III-IVB squamous cell carcinoma of the oral cavity, pharynx or larynx; AND</p> <p>Patient must have tumour(s) that are resectable as assessed by the treating clinician; or</p> <p>Patient must have undergone surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must not have experienced disease recurrence or progression while being treated with this drug for this condition; AND</p> <p>The treatment must be commenced as neoadjuvant therapy and continued in combination with radiation therapy with or without chemotherapy after surgical resection; or</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The treatment must not exceed a total of 12 cumulative months, either as: (i) 17 doses (based on a 3-weekly dose regimen), (ii) 8 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless of if it was PBS/non-PBS subsidised; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resectable locally advanced squamous cell carcinoma of the oral cavity, pharynx or larynx</p><br/><p>Patient must have stage III-IVB squamous cell carcinoma of the oral cavity, pharynx or larynx; AND</p> <p>Patient must have tumour(s) that are resectable as assessed by the treating clinician; or</p> <p>Patient must have undergone surgical resection; AND</p> <p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must not have experienced disease recurrence or progression while being treated with this drug for this condition; AND</p> <p>The treatment must be commenced as neoadjuvant therapy and continued in combination with radiation therapy with or without chemotherapy after surgical resection; or</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The treatment must not exceed a total of 12 cumulative months, either as: (i) 17 doses (based on a 3-weekly dose regimen), (ii) 8 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless of if it was PBS/non-PBS subsidised; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18414_18414_R","null","STREAMLINED","18414","18414","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18415_18415_R","null","STREAMLINED","18415","18415","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Faecal impaction</p><br/><p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Faecal impaction</p><br/><p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18416_18416_R","null","STREAMLINED","18416","18416","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have malignant neoplasia.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have malignant neoplasia.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18417_18417_R","Initial treatment - neoadjuvant setting","STREAMLINED","18417","18417","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urothelial carcinoma</p><br/><p>Initial treatment - neoadjuvant setting</p><br/><p>Patient must be initiating treatment with this drug for this condition; or</p> <p>Patient must be transitioning from non-PBS to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must not have previously been treated with systemic therapy for muscle-invasive bladder cancer at the time this drug was initiated for this condition; AND</p> <p>The treatment must be once in a lifetime with this drug for this condition; AND</p> <p>The condition must be of muscle-invasive type disease with both: (i) clinical tumour stage of either T2, T3 or T4a, (ii) nodal status of up to stage N1; AND</p> <p>The treatment must be for neoadjuvant use in a patient preparing for radical cystectomy; AND</p> <p>Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND</p> <p>The treatment must be/have been initiated with both: (i) gemcitabine, (ii) cisplatin (refer to Product Information of gemcitabine and cisplatin for dosing information); AND</p> <p>Patient must not be undergoing PBS-subsidised treatment where this prescription extends treatment beyond whichever comes first: (i) 4 cycles from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease progression recurrence despite treatment with this drug, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word ''cancelled'' where this occurs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urothelial carcinoma</p><br/><p>Initial treatment - neoadjuvant setting</p><br/><p>Patient must be initiating treatment with this drug for this condition; or</p> <p>Patient must be transitioning from non-PBS to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must not have previously been treated with systemic therapy for muscle-invasive bladder cancer at the time this drug was initiated for this condition; AND</p> <p>The treatment must be once in a lifetime with this drug for this condition; AND</p> <p>The condition must be of muscle-invasive type disease with both: (i) clinical tumour stage of either T2, T3 or T4a, (ii) nodal status of up to stage N1; AND</p> <p>The treatment must be for neoadjuvant use in a patient preparing for radical cystectomy; AND</p> <p>Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND</p> <p>The treatment must be/have been initiated with both: (i) gemcitabine, (ii) cisplatin (refer to Product Information of gemcitabine and cisplatin for dosing information); AND</p> <p>Patient must not be undergoing PBS-subsidised treatment where this prescription extends treatment beyond whichever comes first: (i) 4 cycles from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease progression recurrence despite treatment with this drug, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word ''cancelled'' where this occurs.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18421_18423_R","Initial treatment - Treatment refractory gMG patients (Non-loading/maintenance doses)","AUTHORITY_REQUIRED","18423","18421","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Initial treatment - Treatment refractory gMG patients (Non-loading/maintenance doses)</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must not have received treatment with a gMG biologic within 3 months prior to the first authority application for this indication (i.e. in treatment refractory setting); or</p> <p>Patient must be considered by the treating clinician to have deteriorating gMG disease during a treatment break with a gMG biological agent; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND</p> <p>The treatment must provide no more than 6 months of therapy per initial authority application; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Patients who are considered to have deteriorating gMG disease while on a treatment break with a gMG biologic may qualify with 9 months of remission inducing treatments (rather than 12 months).</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient dose of the drug, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include:</p><p align=""justify"">(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];</p><p align=""justify"">(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessments were conducted).</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Initial treatment - Treatment refractory gMG patients (Non-loading/maintenance doses)</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must not have received treatment with a gMG biologic within 3 months prior to the first authority application for this indication (i.e. in treatment refractory setting); or</p> <p>Patient must be considered by the treating clinician to have deteriorating gMG disease during a treatment break with a gMG biological agent; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must have a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND</p> <p>The treatment must provide no more than 6 months of therapy per initial authority application; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">Patients who are considered to have deteriorating gMG disease while on a treatment break with a gMG biologic may qualify with 9 months of remission inducing treatments (rather than 12 months).</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient dose of the drug, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include:</p><p align=""justify"">(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];</p><p align=""justify"">(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessments were conducted).</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18422_18134_R","Non-loading/maintenance doses","AUTHORITY_REQUIRED","18134","18422","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute severe generalised myasthenia gravis (gMG)</p><br/><p>Non-loading/maintenance doses</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must be considered by the treating clinician to have rapidly deteriorating gMG disease in the absence of immediate treatment with a gMG biological agent; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must be commencing treatment with an NS-IST within 2 weeks; or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must be receiving concomitant treatment with an oral corticosteroid; AND</p> <p>Patient must not receive more than 3 months of total treatment with gMG biological agents under this PBS indication (''acute severe gMG''); AND</p> <p>Patient must not have accessed a prior PBS-subsidised gMG biological agent; or</p> <p>Patient must have received a loading dose of this drug for this indication; or</p> <p>Patient must have developed an intolerance/toxicity to a PBS-subsidised gMG biological agent necessitating a change in treatment; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient dose of the drug, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute severe generalised myasthenia gravis (gMG)</p><br/><p>Non-loading/maintenance doses</p><br/><p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must be considered by the treating clinician to have rapidly deteriorating gMG disease in the absence of immediate treatment with a gMG biological agent; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must be commencing treatment with an NS-IST within 2 weeks; or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must be receiving concomitant treatment with an oral corticosteroid; AND</p> <p>Patient must not receive more than 3 months of total treatment with gMG biological agents under this PBS indication (''acute severe gMG''); AND</p> <p>Patient must not have accessed a prior PBS-subsidised gMG biological agent; or</p> <p>Patient must have received a loading dose of this drug for this indication; or</p> <p>Patient must have developed an intolerance/toxicity to a PBS-subsidised gMG biological agent necessitating a change in treatment; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient dose of the drug, according to the specified dosage in the TGA approved Product Information (PI).</p><p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Consider strengths and combinations that minimise drug wastage. A separate authority prescription form must be completed for each strength requested.</p><p align=""justify"">Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the TGA PI will not be approved.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include the following:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","Y","4708"
"18424_18424_R","Initial 3: New patient (transitioning from PBS-subsidised garadacimab)","AUTHORITY_REQUIRED","18424","18424","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 3: New patient (transitioning from PBS-subsidised garadacimab)</p><br/><p>Patient must have been receiving garadacimab through the PBS as routine prophylaxis for hereditary angioedema immediately prior to receiving this drug; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist; AND</p> <p>Patient must be aged 12 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 3: New patient (transitioning from PBS-subsidised garadacimab)</p><br/><p>Patient must have been receiving garadacimab through the PBS as routine prophylaxis for hereditary angioedema immediately prior to receiving this drug; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18426_18333_R","Initial 1 - treatment of narcolepsy without cataplexy","AUTHORITY_REQUIRED","18333","18426","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Initial 1 - treatment of narcolepsy without cataplexy</p><br/><p>Must be treated by a qualified sleep medicine practitioner or neurologist; AND</p> <p>The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; or</p> <p>The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND</p> <p>Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND</p> <p>Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); or</p> <p>Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; AND</p> <p>Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.</p> <p align=""justify"">The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:</p><p align=""justify"">(a) a psychiatric disorder;</p><p align=""justify"">(b) a cardiovascular disorder;</p><p align=""justify"">(c) a history of substance abuse;</p><p align=""justify"">(d) glaucoma;</p><p align=""justify"">(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.</p> <p align=""left"">The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration.</p> <p align=""justify"">The authority application must be made in writing and must include the following:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and</p><p align=""justify"">(c) details of the contraindication or intolerance to dexamfetamine sulfate; and</p><p align=""justify"">(d) either:</p><p align=""justify"">(i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or</p><p align=""justify"">(ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist.</p><p align=""justify"">The polysomnography, MSLT or EEG test reports must be provided with the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Narcolepsy</p><br/><p>Initial 1 - treatment of narcolepsy without cataplexy</p><br/><p>Must be treated by a qualified sleep medicine practitioner or neurologist; AND</p> <p>The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; or</p> <p>The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND</p> <p>Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND</p> <p>Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); or</p> <p>Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; AND</p> <p>Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.</p> <p align=""justify"">The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:</p><p align=""justify"">(a) a psychiatric disorder;</p><p align=""justify"">(b) a cardiovascular disorder;</p><p align=""justify"">(c) a history of substance abuse;</p><p align=""justify"">(d) glaucoma;</p><p align=""justify"">(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.</p> <p align=""left"">The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration.</p> <p align=""justify"">The authority application must be made in writing and must include the following:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and</p><p align=""justify"">(c) details of the contraindication or intolerance to dexamfetamine sulfate; and</p><p align=""justify"">(d) either:</p><p align=""justify"">(i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or</p><p align=""justify"">(ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist.</p><p align=""justify"">The polysomnography, MSLT or EEG test reports must be provided with the authority application.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18427_18428_R","Initial treatment","AUTHORITY_REQUIRED","18428","18427","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Branch retinal vein occlusion with macular oedema</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; or</p> <p>Patient must have failed prior treatment with VEGF inhibitors; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Branch retinal vein occlusion with macular oedema</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; or</p> <p>Patient must have failed prior treatment with VEGF inhibitors; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18430_18263_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18263","18430","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 18 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ankylosing spondylitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND</p> <p>Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND</p> <p>Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND</p> <p>Patient must not receive more than 18 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and</p><p align=""justify"">(ii) a baseline BASDAI score; and</p><p align=""justify"">(iii) a baseline ESR and/or CRP level.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18432_18464_R","Initial treatment - Initial 2 (Change of treatment)","AUTHORITY_REQUIRED","18464","18432","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; or</p> <p>Patient must have each of: (i) total serum human immunoglobulin E of at least 30 IU/mL measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma, (ii) past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND</p> <p>Patient must have received regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter.</p><p align=""justify"">A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and</p><p align=""justify"">(b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and</p><p align=""justify"">(c) if applicable, the eosinophil count and date; and</p><p align=""justify"">(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and</p><p align=""justify"">(e) if applicable, the IgE result and date; and</p><p align=""justify"">(f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; or</p> <p>Patient must have each of: (i) total serum human immunoglobulin E of at least 30 IU/mL measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma, (ii) past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND</p> <p>Patient must have received regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter.</p><p align=""justify"">A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and</p><p align=""justify"">(b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and</p><p align=""justify"">(c) if applicable, the eosinophil count and date; and</p><p align=""justify"">(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and</p><p align=""justify"">(e) if applicable, the IgE result and date; and</p><p align=""justify"">(f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18433_18174_R","Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)","AUTHORITY_REQUIRED","18174","18433","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.</p> <p align=""justify"">If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.</p> <p align=""justify"">If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18435_18439_R","Initial treatment - Initial 1, Face, hand, foot (new patient)","AUTHORITY_REQUIRED","18439","18435","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""left"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""left"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18438_18468_R","Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18468","18438","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""left"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""left"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18440_18441_R","First continuing treatment","AUTHORITY_REQUIRED","18441","18440","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.</p> <p>Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.</p> <p>Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18442_18357_R","Initial treatment occurring after onasemnogene abeparvovec therapy in a patient with Type 1 SMA","AUTHORITY_REQUIRED","18357","18442","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Initial treatment occurring after onasemnogene abeparvovec therapy in a patient with Type 1 SMA</p><br/><p>Patient must have experienced a regression in a developmental state listed below (see ''Definition'') despite treatment with gene therapy - confirm that this: (i) not due to an acute concomitant illness; (ii) not due to non-compliance to best-supportive care, (iii) apparent for at least 3 months, (iv) verified by another clinician in the treatment team - state the full name of this clinician plus their profession (e.g. medical practitioner, nurse, physiotherapist; this is not an exhaustive list of examples); AND</p> <p>The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; AND</p> <p>Patient must be undergoing treatment under this Treatment phase listing once only - for continuing treatment beyond this authority application, refer to the drug''s relevant ''Continuing treatment'' listing for the patient''s SMA type; AND</p> <p>Patient must have a prior authority approval for any drug PBS-listed for symptomatic Type 1 SMA, with at least one approval having been for gene therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.</p><p align=""justify"">Confirm that a previous PBS authority application has been approved for symptomatic Type 1 SMA.</p> <p align=""justify"">Definition:</p><p align=""justify"">Various childhood developmental states (1 to 9) are listed below, some followed by further observations (a up to d). Where at least one developmental state/observation is no longer present, that developmental state has regressed.</p><p align=""justify"">0. Absence of developmental states (1 to 9) listed below:</p><p align=""justify"">1. Rolls from side to side on back;</p><p align=""justify"">2. Child holds head erect for at least 3 seconds unsupported;</p><p align=""justify"">3. Sitting, but with assistance;</p><p align=""justify"">4. Sitting without assistance:</p><p align=""justify"">(a) Child sits up straight with the head erect for at least 10 seconds;</p><p align=""justify"">(b) Child does not use arms or hands to balance body or support position.</p><p align=""justify"">5. Hands and knees crawling:</p><p align=""justify"">(a) Child alternately moves forward or backwards on hands and knees;</p><p align=""justify"">(b) The stomach does not touch the supporting surface;</p><p align=""justify"">(c) There are continuous and consecutive movements at least 3 in a row.</p><p align=""justify"">6. Standing with assistance:</p><p align=""justify"">(a) Child stands in upright position on both feet, holding onto a stable object (e.g. furniture) with both hands and without leaning on object;</p><p align=""justify"">(b)The body does not touch the stable object, and the legs support most of the body weight;</p><p align=""justify"">(c) Child thus stands with assistance for at least 10 seconds.</p><p align=""justify"">7. Standing alone:</p><p align=""justify"">(a) Child stands in upright position on both feet (not on the toes) with the back straight;</p><p align=""justify"">(b) The leg supports 100% of the child&apos;s weight;</p><p align=""justify"">(c) There is no contact with a person or object;</p><p align=""justify"">(d) Child stands alone for at least 10 seconds.</p><p align=""justify"">8. Walking with assistance:</p><p align=""justify"">(a) Child is in an upright position with the back straight;</p><p align=""justify"">(b) Child makes sideways or forced steps by holding onto a stable object (e.g. furniture) with 1 or both hands;</p><p align=""justify"">(c) One leg moves forward while the other supports part of the body weight;</p><p align=""justify"">(d) Child takes at least 5 steps in this manner.</p><p align=""justify"">9. Walking alone:</p><p align=""justify"">(a) Child takes at least 5 steps independently in upright position with the back straight;</p><p align=""justify"">(b) One leg moves forward while the other supports most of the body weight;</p><p align=""justify"">(c) There is no contact with a person or object.</p><p align=""justify"">Confirm which developmental state has regressed by: (i) stating the overall developmental state (1 - 9) the patient was in at the time of gene therapy, or, the best developmental state achieved since gene therapy, and (ii) stating the patient&apos;s current overall developmental state (i.e. a number that is lower than stated in (i).</p><p align=""justify"">Where the patient has neither regressed from a developmental state nor reached the next developmental state, PBS-subsidy of this benefit is not available.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Initial treatment occurring after onasemnogene abeparvovec therapy in a patient with Type 1 SMA</p><br/><p>Patient must have experienced a regression in a developmental state listed below (see ''Definition'') despite treatment with gene therapy - confirm that this: (i) not due to an acute concomitant illness; (ii) not due to non-compliance to best-supportive care, (iii) apparent for at least 3 months, (iv) verified by another clinician in the treatment team - state the full name of this clinician plus their profession (e.g. medical practitioner, nurse, physiotherapist; this is not an exhaustive list of examples); AND</p> <p>The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; AND</p> <p>Patient must be undergoing treatment under this Treatment phase listing once only - for continuing treatment beyond this authority application, refer to the drug''s relevant ''Continuing treatment'' listing for the patient''s SMA type; AND</p> <p>Patient must have a prior authority approval for any drug PBS-listed for symptomatic Type 1 SMA, with at least one approval having been for gene therapy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.</p><p align=""justify"">Confirm that a previous PBS authority application has been approved for symptomatic Type 1 SMA.</p> <p align=""justify"">Definition:</p><p align=""justify"">Various childhood developmental states (1 to 9) are listed below, some followed by further observations (a up to d). Where at least one developmental state/observation is no longer present, that developmental state has regressed.</p><p align=""justify"">0. Absence of developmental states (1 to 9) listed below:</p><p align=""justify"">1. Rolls from side to side on back;</p><p align=""justify"">2. Child holds head erect for at least 3 seconds unsupported;</p><p align=""justify"">3. Sitting, but with assistance;</p><p align=""justify"">4. Sitting without assistance:</p><p align=""justify"">(a) Child sits up straight with the head erect for at least 10 seconds;</p><p align=""justify"">(b) Child does not use arms or hands to balance body or support position.</p><p align=""justify"">5. Hands and knees crawling:</p><p align=""justify"">(a) Child alternately moves forward or backwards on hands and knees;</p><p align=""justify"">(b) The stomach does not touch the supporting surface;</p><p align=""justify"">(c) There are continuous and consecutive movements at least 3 in a row.</p><p align=""justify"">6. Standing with assistance:</p><p align=""justify"">(a) Child stands in upright position on both feet, holding onto a stable object (e.g. furniture) with both hands and without leaning on object;</p><p align=""justify"">(b)The body does not touch the stable object, and the legs support most of the body weight;</p><p align=""justify"">(c) Child thus stands with assistance for at least 10 seconds.</p><p align=""justify"">7. Standing alone:</p><p align=""justify"">(a) Child stands in upright position on both feet (not on the toes) with the back straight;</p><p align=""justify"">(b) The leg supports 100% of the child&apos;s weight;</p><p align=""justify"">(c) There is no contact with a person or object;</p><p align=""justify"">(d) Child stands alone for at least 10 seconds.</p><p align=""justify"">8. Walking with assistance:</p><p align=""justify"">(a) Child is in an upright position with the back straight;</p><p align=""justify"">(b) Child makes sideways or forced steps by holding onto a stable object (e.g. furniture) with 1 or both hands;</p><p align=""justify"">(c) One leg moves forward while the other supports part of the body weight;</p><p align=""justify"">(d) Child takes at least 5 steps in this manner.</p><p align=""justify"">9. Walking alone:</p><p align=""justify"">(a) Child takes at least 5 steps independently in upright position with the back straight;</p><p align=""justify"">(b) One leg moves forward while the other supports most of the body weight;</p><p align=""justify"">(c) There is no contact with a person or object.</p><p align=""justify"">Confirm which developmental state has regressed by: (i) stating the overall developmental state (1 - 9) the patient was in at the time of gene therapy, or, the best developmental state achieved since gene therapy, and (ii) stating the patient&apos;s current overall developmental state (i.e. a number that is lower than stated in (i).</p><p align=""justify"">Where the patient has neither regressed from a developmental state nor reached the next developmental state, PBS-subsidy of this benefit is not available.</p> <p align=""justify"">The approved Product Information recommended dosing is as follows:</p><p align=""justify"">(i) 16 days to less than 2 months of age: 0.15 mg/kg</p><p align=""justify"">(ii) 2 months to less than 2 years of age: 0.20 mg/kg</p><p align=""justify"">(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg</p><p align=""justify"">(iv) 2 years of age and older weighing 20 kg or more: 5 mg</p> <p align=""justify"">In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:</p><p align=""justify"">1 unit where (i) applies;</p><p align=""justify"">2 units where (ii) applies;</p><p align=""justify"">3 units where (iii) applies;</p><p align=""justify"">3 units where (iv) applies.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18443_18406_R","Initial treatment from week 0 to week 24","AUTHORITY_REQUIRED","18406","18443","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Newly diagnosed systemic light chain amyloidosis</p><br/><p>Initial treatment from week 0 to week 24</p><br/><p>The condition must have histological evidence consistent with a diagnosis of systemic light-chain amyloidosis; AND</p> <p>The condition must be untreated with drug therapy, including this drug, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis changes between multiple myeloma/amyloidosis); AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND</p> <p>Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND</p> <p>Patient must be undergoing concomitant treatment limited to each of: (i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the drug''s approved Product Information.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:</p> <p align=""justify"">Details of the histological evidence supporting the diagnosis of systemic light chain amyloidosis, limited to: (i) the name of pathologist/pathology provider, (ii) the site of biopsy</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Newly diagnosed systemic light chain amyloidosis</p><br/><p>Initial treatment from week 0 to week 24</p><br/><p>The condition must have histological evidence consistent with a diagnosis of systemic light-chain amyloidosis; AND</p> <p>The condition must be untreated with drug therapy, including this drug, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis changes between multiple myeloma/amyloidosis); AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND</p> <p>Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND</p> <p>Patient must be undergoing concomitant treatment limited to each of: (i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the drug''s approved Product Information.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:</p> <p align=""justify"">Details of the histological evidence supporting the diagnosis of systemic light chain amyloidosis, limited to: (i) the name of pathologist/pathology provider, (ii) the site of biopsy</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18444_N","null","null","null","null","null","<p/><p align=""justify"">A moderate risk of developing breast cancer is if the lifetime breast cancer risk is 1.5 to 3 times the population average. A high risk of developing breast cancer is if the lifetime breast cancer risk is more than 3 times the population average.</p><p/>","Y","N","N","null","null","N","2016-10-01","N","4708"
"18448_18223_R","Continuing treatment as a reclassified patient","AUTHORITY_REQUIRED","18223","18448","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must be undergoing continuing PBS-subsidised therapy with this drug where the most recent authority approval for this drug was for a different PBS indication to that stated above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication where the most recent authority approval was for a different growth hormone, (v) reclassify the PBS indication and recommence treatment simultaneously; AND</p> <p>The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age plus sex immediately prior to commencing treatment.</p><p align=""justify"">2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Continuing treatment as a reclassified patient</p><br/><p>Patient must be undergoing continuing PBS-subsidised therapy with this drug where the most recent authority approval for this drug was for a different PBS indication to that stated above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication where the most recent authority approval was for a different growth hormone, (v) reclassify the PBS indication and recommence treatment simultaneously; AND</p> <p>The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug''s approved Product Information) dose; AND</p> <p>Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or</p> <p>Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR</p><p align=""justify"">(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1<sup>st</sup> percentile for age plus sex immediately prior to commencing treatment.</p><p align=""justify"">2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.</p><p align=""justify"">3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.</p><p align=""justify"">4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18450_18450_R","Continuing treatment","STREAMLINED","18450","18450","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk locally advanced carcinoma of the cervix</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this indication; AND</p> <p>Patient must not have experienced disease recurrence while being treated with this drug for this indication; AND</p> <p>The treatment must be the sole PBS-subsidised anti-cancer therapy for this condition; AND</p> <p>The treatment must not exceed a total of (i) 24 months, (ii) 35 doses (based on a 3-weekly dose regimen), (iii) 17 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless if it was PBS/non-PBS subsidised; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>High risk locally advanced carcinoma of the cervix</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this indication; AND</p> <p>Patient must not have experienced disease recurrence while being treated with this drug for this indication; AND</p> <p>The treatment must be the sole PBS-subsidised anti-cancer therapy for this condition; AND</p> <p>The treatment must not exceed a total of (i) 24 months, (ii) 35 doses (based on a 3-weekly dose regimen), (iii) 17 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless if it was PBS/non-PBS subsidised; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18451_18310_R","Initial treatment","STREAMLINED","18310","18451","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced carcinoma of the cervix</p><br/><p>Initial treatment</p><br/><p>The condition must be at least one of (i) persistent carcinoma, (ii) recurrent carcinoma, (iii) metastatic carcinoma of the cervix; AND</p> <p>The condition must be unsuitable for curative treatment with either of (i) surgical resection, (ii) radiation; AND</p> <p>Patient must have WHO performance status no higher than 1; AND</p> <p>Patient must not have received prior PBS-subsidised treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor in any earlier line of carcinoma of the cervix; AND</p> <p>Patient must be undergoing concomitant treatment with chemotherapy, containing a minimum of: (i) a platinum-based chemotherapy agent, plus (ii) paclitaxel; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced carcinoma of the cervix</p><br/><p>Initial treatment</p><br/><p>The condition must be at least one of (i) persistent carcinoma, (ii) recurrent carcinoma, (iii) metastatic carcinoma of the cervix; AND</p> <p>The condition must be unsuitable for curative treatment with either of (i) surgical resection, (ii) radiation; AND</p> <p>Patient must have WHO performance status no higher than 1; AND</p> <p>Patient must not have received prior PBS-subsidised treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor in any earlier line of carcinoma of the cervix; AND</p> <p>Patient must be undergoing concomitant treatment with chemotherapy, containing a minimum of: (i) a platinum-based chemotherapy agent, plus (ii) paclitaxel; AND</p> <p>Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or</p> <p>Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18454_18454_R","Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis)","AUTHORITY_REQUIRED","18454","18454","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis)</p><br/><p>Patient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment with this drug; AND</p> <p>Patient must not have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema at the time of application; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist.</p> <p align=""justify"">For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate</p> <p align=""justify"">The baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating treatment must be provided at the time of submitting this application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis)</p><br/><p>Patient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment with this drug; AND</p> <p>Patient must not have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema at the time of application; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist.</p> <p align=""justify"">For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate</p> <p align=""justify"">The baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating treatment must be provided at the time of submitting this application.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18456_18243_R","Initial treatment - 4 weekly treatment regimen","STREAMLINED","18243","18456","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Initial treatment - 4 weekly treatment regimen</p><br/><p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The condition must have progressed on or after prior platinum based chemotherapy; or</p> <p>The condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Initial treatment - 4 weekly treatment regimen</p><br/><p>Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The condition must have progressed on or after prior platinum based chemotherapy; or</p> <p>The condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18457_18458_R","Continuing Treatment for patients with T315I mutation","AUTHORITY_REQUIRED","18458","18457","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing Treatment for patients with T315I mutation</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%; or</p> <p>Patient must be undergoing subsequent continuing treatment with this drug, demonstrating a 12-month response of either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The continuing application for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a major cytogenetic response [see Note explaining definitions of response]; or</p><p align=""justify"">(ii) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response].</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib, ponatinib or asciminib at any one time and must not be receiving concomitant interferon alfa therapy</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myeloid Leukaemia (CML)</p><br/><p>Continuing Treatment for patients with T315I mutation</p><br/><p>Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%; or</p> <p>Patient must be undergoing subsequent continuing treatment with this drug, demonstrating a 12-month response of either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%.</p> <p align=""justify"">A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The continuing application for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(i) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a major cytogenetic response [see Note explaining definitions of response]; or</p><p align=""justify"">(ii) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response].</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib, ponatinib or asciminib at any one time and must not be receiving concomitant interferon alfa therapy</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18459_18336_R","Initial treatment","AUTHORITY_REQUIRED","18336","18459","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central retinal vein occlusion with macular oedema</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; or</p> <p>Patient must have failed prior treatment with VEGF inhibitors; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Central retinal vein occlusion with macular oedema</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND</p> <p>The condition must be diagnosed by optical coherence tomography; or</p> <p>The condition must be diagnosed by fluorescein angiography; AND</p> <p>Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; or</p> <p>Patient must have failed prior treatment with VEGF inhibitors; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18460_18460_R","Initial treatment","AUTHORITY_REQUIRED","18460","18460","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of Acute Hepatic Porphyria (AHP)</p><br/><p>Initial treatment</p><br/><p>Patient must have a confirmed diagnosis of AHP based on clinical features; AND</p> <p>Patient must have a previous result that showed a 4 times greater than the upper limit of normal (ULN) on one of the following tests: (i) urinary porphobilinogen, (ii) plasma porphobilinogen, (iii) delta-aminolevulinic acid; AND</p> <p>Patient must have had at least 2 porphyria attacks (requiring hospitalisation, presentation at an emergency department, or medical intervention via a porphyria clinic) within the 6 months prior to: (i) commencement of this drug; or (ii) prophylactic treatment with gonadotropin-releasing hormone analogues or hemin; AND</p> <p>Patient must not have previously undergone a liver transplant; AND</p> <p>The treatment must be initiated under the supervision of a healthcare professional experienced in the management of porphyria; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">For the purposes of administering this restriction, clinical features to confirm a diagnosis of AHP can include but are not limited to acute attacks of: abdominal, back, chest, extremities, and/or limb pain.</p> <p align=""justify"">At the time of the authority application, prescribers should request the appropriate number of vials for a single dose based on the patient&apos;s weight, as per the TGA-approved Product Information.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) The baseline number of porphyria attacks within a defined 6-month period [dates of the 6-month period must be included].</p><p align=""justify"">(2) Pathology measurements that indicate 4 times greater than the ULN of one of the following tests:</p><p align=""justify"">(i) urinary porphobilinogen;</p><p align=""justify"">(ii) plasma porphobilinogen;</p><p align=""justify"">(iii) delta-aminolevulinic acid.</p><p align=""justify"">Date of pathology report and unique identifying number/code that links the pathology result to the individual patient must be included.</p><p align=""justify"">(3) Current weight of the patient.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of Acute Hepatic Porphyria (AHP)</p><br/><p>Initial treatment</p><br/><p>Patient must have a confirmed diagnosis of AHP based on clinical features; AND</p> <p>Patient must have a previous result that showed a 4 times greater than the upper limit of normal (ULN) on one of the following tests: (i) urinary porphobilinogen, (ii) plasma porphobilinogen, (iii) delta-aminolevulinic acid; AND</p> <p>Patient must have had at least 2 porphyria attacks (requiring hospitalisation, presentation at an emergency department, or medical intervention via a porphyria clinic) within the 6 months prior to: (i) commencement of this drug; or (ii) prophylactic treatment with gonadotropin-releasing hormone analogues or hemin; AND</p> <p>Patient must not have previously undergone a liver transplant; AND</p> <p>The treatment must be initiated under the supervision of a healthcare professional experienced in the management of porphyria; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">For the purposes of administering this restriction, clinical features to confirm a diagnosis of AHP can include but are not limited to acute attacks of: abdominal, back, chest, extremities, and/or limb pain.</p> <p align=""justify"">At the time of the authority application, prescribers should request the appropriate number of vials for a single dose based on the patient&apos;s weight, as per the TGA-approved Product Information.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) The baseline number of porphyria attacks within a defined 6-month period [dates of the 6-month period must be included].</p><p align=""justify"">(2) Pathology measurements that indicate 4 times greater than the ULN of one of the following tests:</p><p align=""justify"">(i) urinary porphobilinogen;</p><p align=""justify"">(ii) plasma porphobilinogen;</p><p align=""justify"">(iii) delta-aminolevulinic acid.</p><p align=""justify"">Date of pathology report and unique identifying number/code that links the pathology result to the individual patient must be included.</p><p align=""justify"">(3) Current weight of the patient.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18467_18437_R","First continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","18437","18467","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align=""justify"">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align=""justify"">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align=""justify"">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18471_18191_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","18191","18471","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An assessment of a patient&apos;s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align=""justify"">either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An assessment of a patient&apos;s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p>Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 3 months treatment with methotrexate and 3 months treatment with sulfasalazine or leflunomide can be found on the Department of Human Services website (www.humanservices.gov.au)</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). </p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Department of Human Services website at www.humanservices.gov.au</p><p align=""justify"">Applications for authority to prescribe should be forwarded to: </p><p align=""justify"">Department of Human Services</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826 </p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18472_18198_R","Continuing treatment","AUTHORITY_REQUIRED","18198","18472","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Type III Short bowel syndrome with intestinal failure</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit; AND</p> <p>Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND</p> <p>Patient must have a reduction in parenteral support frequency of at least one day per week compared to the mean number of days per week at baseline; or</p> <p>Patient must have, as a patient yet to turn 18 years of age, a reduction in the mean weekly parenteral support volume of at least 20% (mL per kg of body weight) relative to baseline; or</p> <p>The treatment must be resuming after a break in therapy, but before the break in therapy occurred, a reduction in parenteral support relative to baseline had been occurring to an extent as stated as above.</p> <p align=""justify"">Refer to the measurement(s) stated in the Initial treatment authority application for the baseline dependence on parenteral support. Determine the current mean use per week of parental support in days (for a patient of any age) and/or the mean volume per week in mL per kg (for a patient yet to turn 18 years of age). State these values in this authority application.</p> <p align=""justify"">The current mean number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over a 4 week timeframe that best represents the average of the preceding treatment period.</p> <p align=""justify"">The current mean weekly parenteral support volume is calculated as the mean mL per kg of body weight of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over a 4 week timeframe that best represents the average of the preceding treatment period.</p> <p align=""justify"">From 1 September 2021</p><p align=""justify"">Where the mean weekly volume of parenteral support in terms of mL per kg of body weight for 4 consecutive weeks has not been stated in an Initial treatment authority application for a patient yet to turn 18 years of age, provide in this authority application both:</p><p align=""justify"">(i) a known or estimated retrospective baseline value that would have applied to the patient immediately before commencing treatment with this drug, and</p><p align=""justify"">(ii) the current value (observed over a 4 week timeframe)</p><p align=""justify"">Provide these values for a child only where mean weekly volume is to be used as an alternative response assessment to mean days of parenteral support per week. Otherwise, continue to use mean days per week.</p> <p align=""justify"">Where treatment is resuming after a break in treatment with this drug, state parenteral support days/volume values as occurring prior to the break instead of current values.</p> <p align=""justify"">A patient who has turned 18 years of age since their last authority application may be assessed for response using either the mean number of days of parenteral support or mean volume of parenteral support. Any subsequent authority application after this application must be assessed using the mean number of days of parenteral support.</p> <p align=""justify"">Patients who do not meet the clinical criteria with respect to demonstrating the minimum reduction in parenteral support must permanently discontinue PBS subsidy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Type III Short bowel syndrome with intestinal failure</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit; AND</p> <p>Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND</p> <p>Patient must have a reduction in parenteral support frequency of at least one day per week compared to the mean number of days per week at baseline; or</p> <p>Patient must have, as a patient yet to turn 18 years of age, a reduction in the mean weekly parenteral support volume of at least 20% (mL per kg of body weight) relative to baseline; or</p> <p>The treatment must be resuming after a break in therapy, but before the break in therapy occurred, a reduction in parenteral support relative to baseline had been occurring to an extent as stated as above.</p> <p align=""justify"">Refer to the measurement(s) stated in the Initial treatment authority application for the baseline dependence on parenteral support. Determine the current mean use per week of parental support in days (for a patient of any age) and/or the mean volume per week in mL per kg (for a patient yet to turn 18 years of age). State these values in this authority application.</p> <p align=""justify"">The current mean number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over a 4 week timeframe that best represents the average of the preceding treatment period.</p> <p align=""justify"">The current mean weekly parenteral support volume is calculated as the mean mL per kg of body weight of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over a 4 week timeframe that best represents the average of the preceding treatment period.</p> <p align=""justify"">From 1 September 2021</p><p align=""justify"">Where the mean weekly volume of parenteral support in terms of mL per kg of body weight for 4 consecutive weeks has not been stated in an Initial treatment authority application for a patient yet to turn 18 years of age, provide in this authority application both:</p><p align=""justify"">(i) a known or estimated retrospective baseline value that would have applied to the patient immediately before commencing treatment with this drug, and</p><p align=""justify"">(ii) the current value (observed over a 4 week timeframe)</p><p align=""justify"">Provide these values for a child only where mean weekly volume is to be used as an alternative response assessment to mean days of parenteral support per week. Otherwise, continue to use mean days per week.</p> <p align=""justify"">Where treatment is resuming after a break in treatment with this drug, state parenteral support days/volume values as occurring prior to the break instead of current values.</p> <p align=""justify"">A patient who has turned 18 years of age since their last authority application may be assessed for response using either the mean number of days of parenteral support or mean volume of parenteral support. Any subsequent authority application after this application must be assessed using the mean number of days of parenteral support.</p> <p align=""justify"">Patients who do not meet the clinical criteria with respect to demonstrating the minimum reduction in parenteral support must permanently discontinue PBS subsidy.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18473_18401_R","Initial 1 - starting combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient","AUTHORITY_REQUIRED","18401","18473","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 - starting combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 - starting combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18474_18475_R","Initial treatment","AUTHORITY_REQUIRED","18475","18474","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe growth failure with primary insulin-like growth factor-1 deficiency</p><br/><p>Initial treatment</p><br/><p>The condition must be caused by severe primary insulin-like growth factor-1 deficiency (IGFD), with IGFD deficiency for the purpose of PBS subsidy defined as a basal IGF-1 level (measured any time prior to initiating treatment with this drug) below the 2.5th percentile adjusted for each of: (i) age, (ii) gender; AND</p> <p>The condition must have resulted in the patient experiencing short stature, with short stature for the purpose of PBS subsidy defined as the patient''s height (measured any time prior to initiating treatment with this drug) being at least 3 standard deviations below the norm, adjusted for each of: (i) age, (ii) gender; AND</p> <p>Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); AND</p> <p>The condition must not be caused by growth hormone deficiency; AND</p> <p>Patient must have a bone age of less than 13.5 years (females); or</p> <p>Patient must have a bone age of less than 15.5 years (males); AND</p> <p>The condition must not be caused by secondary causes of IGFD - prior to initiating treatment with this drug, the treating physician has at least excluded each of the following: (i) malnutrition, (ii) hypopituitarism, (iii) hypothyroidism, (iv) medication side effects; AND</p> <p>The treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing); AND</p> <p>Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type; or</p> <p>Must be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician; AND</p> <p>Patient must be aged from 2 years up until their 18th birthday.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The initial treatment authority application must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include the following:</p><p align=""justify"">(1) Insulin-like growth factor-1 deficiency:</p><p align=""justify"">State each of: (a) the patient&apos;s most recent basal IGF-1 level measured (ng/mL), (b) the measurement date (dd/mm/yy), (c) the name of the pathology result provider;</p><p align=""justify"">(2) Short stature:</p><p align=""justify"">State the patient&apos;s height (cm);</p><p align=""justify"">(3) Normal growth hormone levels:</p><p align=""justify"">State the patient&apos;s most recent growth hormone level measurement (mcg/L) - this figure must be greater than 6.6 mcg/L;</p><p align=""justify"">(4) Bone age: (where the patient has a chronological age of at least 2.5 years):</p><p align=""justify"">State each of: (a) the patient&apos;s bone age in numerical figures at the time when it was most recently determined, (b) the date (dd/mm/yy) of this determination that is within 12 months of this authority application;</p><p align=""justify"">(5) The patient&apos;s weight (kg);</p><p align=""justify"">(6) The prescribed dose (mg/kg) (between 0.04 to 0.12);</p><p align=""justify"">(7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant &apos;NOTE&apos; attached to this listing for guidance.</p><p align=""justify"">Height, growth velocity and weight measurements must not be more than three months old at the time of application.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe growth failure with primary insulin-like growth factor-1 deficiency</p><br/><p>Initial treatment</p><br/><p>The condition must be caused by severe primary insulin-like growth factor-1 deficiency (IGFD), with IGFD deficiency for the purpose of PBS subsidy defined as a basal IGF-1 level (measured any time prior to initiating treatment with this drug) below the 2.5th percentile adjusted for each of: (i) age, (ii) gender; AND</p> <p>The condition must have resulted in the patient experiencing short stature, with short stature for the purpose of PBS subsidy defined as the patient''s height (measured any time prior to initiating treatment with this drug) being at least 3 standard deviations below the norm, adjusted for each of: (i) age, (ii) gender; AND</p> <p>Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); AND</p> <p>The condition must not be caused by growth hormone deficiency; AND</p> <p>Patient must have a bone age of less than 13.5 years (females); or</p> <p>Patient must have a bone age of less than 15.5 years (males); AND</p> <p>The condition must not be caused by secondary causes of IGFD - prior to initiating treatment with this drug, the treating physician has at least excluded each of the following: (i) malnutrition, (ii) hypopituitarism, (iii) hypothyroidism, (iv) medication side effects; AND</p> <p>The treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing); AND</p> <p>Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type; or</p> <p>Must be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician; AND</p> <p>Patient must be aged from 2 years up until their 18th birthday.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""justify"">The initial treatment authority application must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include the following:</p><p align=""justify"">(1) Insulin-like growth factor-1 deficiency:</p><p align=""justify"">State each of: (a) the patient&apos;s most recent basal IGF-1 level measured (ng/mL), (b) the measurement date (dd/mm/yy), (c) the name of the pathology result provider;</p><p align=""justify"">(2) Short stature:</p><p align=""justify"">State the patient&apos;s height (cm);</p><p align=""justify"">(3) Normal growth hormone levels:</p><p align=""justify"">State the patient&apos;s most recent growth hormone level measurement (mcg/L) - this figure must be greater than 6.6 mcg/L;</p><p align=""justify"">(4) Bone age: (where the patient has a chronological age of at least 2.5 years):</p><p align=""justify"">State each of: (a) the patient&apos;s bone age in numerical figures at the time when it was most recently determined, (b) the date (dd/mm/yy) of this determination that is within 12 months of this authority application;</p><p align=""justify"">(5) The patient&apos;s weight (kg);</p><p align=""justify"">(6) The prescribed dose (mg/kg) (between 0.04 to 0.12);</p><p align=""justify"">(7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant &apos;NOTE&apos; attached to this listing for guidance.</p><p align=""justify"">Height, growth velocity and weight measurements must not be more than three months old at the time of application.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS authority application administrator will approve a maximum quantity of vials in line with the following formula (based on the upper dose range of 0.12 mg/kg dosed twice daily, one vial containing 40 mg of drug and target supply duration of 30 days per dispensing):</p><p align=""justify"">Number of vials equals 7.2 multiplied by weight (kg) divided by 40. For ease of reference, this equates to:</p><p align=""justify"">Below 16 kg: up to 3 vials</p><p align=""justify"">16 to 22 kg: up to 4 vials</p><p align=""justify"">22 to 27 kg: up to 5 vials</p><p align=""justify"">27 to 33 kg: up to 6 vials</p><p align=""justify"">33 to 38 kg: up to 7 vials</p><p align=""justify"">38 to 44 kg: up to 8 vials</p><p align=""justify"">Beyond 44 kg: refer to above formula</p> <p align=""justify"">The Centers for Disease Control and Prevention (U.S. Department of Health &amp; Human Services) publishes Clinical Growth Charts which this restriction refers to. Both the &apos;length-for-age&apos; (birth to 36 months) and &apos;stature-for-age&apos; (children 2 years to 20 years) growth charts can be viewed, printed and reproduced via the following website link:</p><p align=""justify"">https://www.cdc.gov/growthcharts/clinical_charts.htm</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18476_18409_R","Initial treatment","AUTHORITY_REQUIRED","18409","18476","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""left"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""left"">1. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; or</p><p align=""left"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex.</p><p align=""left"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""left"">3. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.<br/><br/></p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Short stature associated with biochemical growth hormone deficiency</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or</p> <p>Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND</p> <p>Patient must have a current height at or below the 1st percentile for age and sex; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or</p> <p>Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND</p> <p>Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND</p> <p>Patient must not have an active tumour or evidence of tumour growth or activity; AND</p> <p>Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND</p> <p>Patient must be male and must not have a bone age of 15.5 years or more; or</p> <p>Patient must be female and must not have a bone age of 13.5 years or more; AND</p> <p>Must be treated by a specialist or consultant physician in paediatric endocrinology; or</p> <p>Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND</p> <p>Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.</p> <p align=""justify"">An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.</p> <p align=""left"">Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""left"">1. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; or</p><p align=""left"">(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1<sup>st</sup> percentile for age and sex.</p><p align=""left"">2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.</p><p align=""left"">3. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.<br/><br/></p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the &apos;Notes&apos; section of this restriction.</p> <p align=""justify"">Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.</p> <p align=""justify"">Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.</p> <p align=""justify"">In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18478_18308_R","Initial PBS-subsidised treatment with this drug in a child","AUTHORITY_REQUIRED","18308","18478","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Initial PBS-subsidised treatment with this drug in a child</p><br/><p>Patient must be of an age that is prior to their 19th birthday at the time of this authority application; AND</p> <p>Patient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rd birthday, but before their 19th birthday (SMA type IIIB/IIIC); AND</p> <p>Patient must be 2 years of age or older, and weigh 20 kg or more; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing initial PBS-subsidised treatment with this drug for untreated disease; or</p> <p>Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access); AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:</p><p align=""justify"">(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,</p><p align=""justify"">(ii) Proximal weakness,</p><p align=""justify"">(iii) Hypotonia,</p><p align=""justify"">(iv) Absence of deep tendon reflexes,</p><p align=""justify"">(v) Any active denervation or chronic neurogenic changes found on electromyography,</p><p align=""justify"">(vi) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">In this authority application, confirm:</p><p align=""justify"">(1) the patient&apos;s medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy,</p><p align=""justify"">(2) which of the above (i to vi) (at least 1) were present after their 3<sup>rd</sup> birthday, but before their 19<sup>th</sup> birthday,</p><p align=""justify"">(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)</p><br/><p>Initial PBS-subsidised treatment with this drug in a child</p><br/><p>Patient must be of an age that is prior to their 19th birthday at the time of this authority application; AND</p> <p>Patient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rd birthday, but before their 19th birthday (SMA type IIIB/IIIC); AND</p> <p>Patient must be 2 years of age or older, and weigh 20 kg or more; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing initial PBS-subsidised treatment with this drug for untreated disease; or</p> <p>Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access); AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:</p><p align=""justify"">(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,</p><p align=""justify"">(ii) Proximal weakness,</p><p align=""justify"">(iii) Hypotonia,</p><p align=""justify"">(iv) Absence of deep tendon reflexes,</p><p align=""justify"">(v) Any active denervation or chronic neurogenic changes found on electromyography,</p><p align=""justify"">(vi) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">In this authority application, confirm:</p><p align=""justify"">(1) the patient&apos;s medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy,</p><p align=""justify"">(2) which of the above (i to vi) (at least 1) were present after their 3<sup>rd</sup> birthday, but before their 19<sup>th</sup> birthday,</p><p align=""justify"">(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18479_18479_R","Continuing/maintenance treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene","AUTHORITY_REQUIRED","18479","18479","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must not be undergoing treatment through this ''Continuing treatment'' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy; AND</p> <p>Patient must have been 18 years of age or younger at the time of initial treatment with this drug; AND</p> <p>Patient must be 2 years of age or older, and weigh 20 kg or more.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-symptomatic spinal muscular atrophy (SMA)</p><br/><p>Continuing/maintenance treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND</p> <p>The treatment must be given concomitantly with best supportive care for this condition; AND</p> <p>The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must not be undergoing treatment through this ''Continuing treatment'' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy; AND</p> <p>Patient must have been 18 years of age or younger at the time of initial treatment with this drug; AND</p> <p>Patient must be 2 years of age or older, and weigh 20 kg or more.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18482_18482_R","Continuing treatment - adjuvant setting","STREAMLINED","18482","18482","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urothelial carcinoma</p><br/><p>Continuing treatment - adjuvant setting</p><br/><p>Patient must have previously received PBS-subsidised neoadjuvant treatment with this drug in combination with gemcitabine plus cisplatin for this condition; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS-subsidised treatment with this drug for this condition, (ii) previously treated in combination with cisplatin and gemcitabine as neoadjuvant treatment for this condition; AND</p> <p>Patient must have undergone radical cystectomy; AND</p> <p>The treatment must be for adjuvant therapy that is/was initiated within 6 months of radical cystectomy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) maximum of 8 cycles for this condition from the first administered dose following radical cystectomy, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word ''cancelled'' where this occurs.</p> <p align=""left"">Treatment with this drug for this condition must not exceed 12 treatment cycles (neoadjuvant and adjuvant) in a lifetime.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urothelial carcinoma</p><br/><p>Continuing treatment - adjuvant setting</p><br/><p>Patient must have previously received PBS-subsidised neoadjuvant treatment with this drug in combination with gemcitabine plus cisplatin for this condition; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS-subsidised treatment with this drug for this condition, (ii) previously treated in combination with cisplatin and gemcitabine as neoadjuvant treatment for this condition; AND</p> <p>Patient must have undergone radical cystectomy; AND</p> <p>The treatment must be for adjuvant therapy that is/was initiated within 6 months of radical cystectomy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) maximum of 8 cycles for this condition from the first administered dose following radical cystectomy, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word ''cancelled'' where this occurs.</p> <p align=""left"">Treatment with this drug for this condition must not exceed 12 treatment cycles (neoadjuvant and adjuvant) in a lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18484_18484_R","Initial 2: New patient (commencing from National Blood Authority-funded C1-INH)","AUTHORITY_REQUIRED","18484","18484","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 2: New patient (commencing from National Blood Authority-funded C1-INH)</p><br/><p>Patient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving this drug; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 2: New patient (commencing from National Blood Authority-funded C1-INH)</p><br/><p>Patient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving this drug; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18485_18239_R","Continuing preventative treatment","AUTHORITY_REQUIRED","18239","18485","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Continuing preventative treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab; AND</p> <p>Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Patients who have successfully transitioned to a lower dosing frequency should be reviewed every 6 months to ensure they continue to demonstrate a sustained response</p> <p align=""justify"">For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient&apos;s medical records for auditing purposes.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Continuing preventative treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab; AND</p> <p>Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Patients who have successfully transitioned to a lower dosing frequency should be reviewed every 6 months to ensure they continue to demonstrate a sustained response</p> <p align=""justify"">For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient&apos;s medical records for auditing purposes.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18486_18329_R","Initial treatment","AUTHORITY_REQUIRED","18329","18486","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced basal cell carcinoma (BCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be inappropriate for surgery; AND</p> <p>The condition must be inappropriate for curative radiotherapy; AND</p> <p>Patient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition; or</p> <p>Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) Details (date, unique identifying number/code or provider number) of the histological confirmation of BCC and whether the condition is metastatic or locally advanced; and</p><p align=""justify"">(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that surgery is inappropriate; and</p><p align=""justify"">(c) In patients with locally advanced BCC, written confirmation from a radiation oncologist that curative radiotherapy is inappropriate.</p><p align=""justify"">The assessment of the patient&apos;s response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify""><b>Inappropriate for surgery is defined as:</b></p><p align=""justify"">(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or</p><p align=""justify"">(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or</p><p align=""justify"">(iii) Medical contraindication to surgery.</p><p align=""justify""><b>Inappropriate for curative radiotherapy is defined as:</b></p><p align=""justify"">(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or</p><p align=""justify"">(ii) Limitations due to location of tumour; or</p><p align=""justify"">(iii) Limitations due to cumulative prior radiotherapy dose; or</p><p align=""justify"">(iv) Progressive disease despite prior irradiation of locally advanced BCC.</p> <p align=""justify"">For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery and written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced basal cell carcinoma (BCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be inappropriate for surgery; AND</p> <p>The condition must be inappropriate for curative radiotherapy; AND</p> <p>Patient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition; or</p> <p>Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) Details (date, unique identifying number/code or provider number) of the histological confirmation of BCC and whether the condition is metastatic or locally advanced; and</p><p align=""justify"">(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that surgery is inappropriate; and</p><p align=""justify"">(c) In patients with locally advanced BCC, written confirmation from a radiation oncologist that curative radiotherapy is inappropriate.</p><p align=""justify"">The assessment of the patient&apos;s response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify""><b>Inappropriate for surgery is defined as:</b></p><p align=""justify"">(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or</p><p align=""justify"">(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or</p><p align=""justify"">(iii) Medical contraindication to surgery.</p><p align=""justify""><b>Inappropriate for curative radiotherapy is defined as:</b></p><p align=""justify"">(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or</p><p align=""justify"">(ii) Limitations due to location of tumour; or</p><p align=""justify"">(iii) Limitations due to cumulative prior radiotherapy dose; or</p><p align=""justify"">(iv) Progressive disease despite prior irradiation of locally advanced BCC.</p> <p align=""justify"">For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery and written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18487_18252_R","Continuing treatment","AUTHORITY_REQUIRED","18252","18487","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced basal cell carcinoma (BCC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must remain inappropriate for surgery; AND</p> <p>The condition must remain inappropriate for curative radiotherapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) Confirmation from the treating doctor that the disease has not progressed; and</p><p align=""justify"">(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that the condition remains inappropriate for surgery; or written confirmation from a radiation oncologist that the condition remains inappropriate for curative radiotherapy.</p><p align=""justify"">The assessment of the patient&apos;s response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify""><b>Inappropriate for surgery is defined as:</b></p><p align=""justify"">(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or</p><p align=""justify"">(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or</p><p align=""justify"">(iii) Medical contraindication to surgery.</p><p align=""justify""><b>Inappropriate for curative radiotherapy is defined as:</b></p><p align=""justify"">(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or</p><p align=""justify"">(ii) Limitations due to location of tumour; or</p><p align=""justify"">(iii) Limitations due to cumulative prior radiotherapy dose; or</p><p align=""justify"">(iv) Progressive disease despite prior irradiation of locally advanced BCC.</p> <p align=""justify"">For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic or locally advanced basal cell carcinoma (BCC)</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must remain inappropriate for surgery; AND</p> <p>The condition must remain inappropriate for curative radiotherapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) Confirmation from the treating doctor that the disease has not progressed; and</p><p align=""justify"">(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that the condition remains inappropriate for surgery; or written confirmation from a radiation oncologist that the condition remains inappropriate for curative radiotherapy.</p><p align=""justify"">The assessment of the patient&apos;s response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify""><b>Inappropriate for surgery is defined as:</b></p><p align=""justify"">(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or</p><p align=""justify"">(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or</p><p align=""justify"">(iii) Medical contraindication to surgery.</p><p align=""justify""><b>Inappropriate for curative radiotherapy is defined as:</b></p><p align=""justify"">(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or</p><p align=""justify"">(ii) Limitations due to location of tumour; or</p><p align=""justify"">(iii) Limitations due to cumulative prior radiotherapy dose; or</p><p align=""justify"">(iv) Progressive disease despite prior irradiation of locally advanced BCC.</p> <p align=""justify"">For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18488_18334_R","Dose escalation therapy - Continuing treatment","AUTHORITY_REQUIRED","18334","18488","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Dose escalation therapy - Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have, in order to extend the dose schedule as per the TGA-approved Product Information, between 5% to 15% blasts in either the: (i) bone marrow, (ii) peripheral blood, in conjunction with clinical assessment; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin.</p> <p align=""justify"">Authority applications must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail:</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice)</p><p align=""justify"">(c) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating the blast percentage.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Dose escalation therapy - Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have, in order to extend the dose schedule as per the TGA-approved Product Information, between 5% to 15% blasts in either the: (i) bone marrow, (ii) peripheral blood, in conjunction with clinical assessment; AND</p> <p>Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin.</p> <p align=""justify"">Authority applications must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail:</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice)</p><p align=""justify"">(c) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating the blast percentage.</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18489_18490_R","Initial treatment","AUTHORITY_REQUIRED","18490","18489","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to age-related macular degeneration (AMD); AND</p> <p>Patient must have persistent macular exudation, as determined clinically and/or by optical coherence tomography or fluorescein angiography, despite at least 6 months of PBS-subsidised treatment with: 1. Aflibercept and/or 2. Ranibizumab and/or 3. Faricimab; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Subfoveal choroidal neovascularisation (CNV)</p><br/><p>Initial treatment</p><br/><p>Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND</p> <p>The condition must be due to age-related macular degeneration (AMD); AND</p> <p>Patient must have persistent macular exudation, as determined clinically and/or by optical coherence tomography or fluorescein angiography, despite at least 6 months of PBS-subsidised treatment with: 1. Aflibercept and/or 2. Ranibizumab and/or 3. Faricimab; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition.</p> <p>Authority approval for initial treatment of each eye must be sought.</p> <p align=""justify"">The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18492_18345_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","18345","18492","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 22 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.</p> <p align=""justify"">Up to a maximum of 3 repeats will be authorised.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-04-01","Y","4708"
"18494_18225_R","Initial PBS-subsidised treatment with this drug in an adult who did not initiate PBS subsidy with this drug during childhood","AUTHORITY_REQUIRED","18225","18494","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Initial PBS-subsidised treatment with this drug in an adult who did not initiate PBS subsidy with this drug during childhood</p><br/><p>Patient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; AND</p> <p>Patient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19th birthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS-subsidised); AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing initial PBS-subsidised treatment with this drug for untreated disease; or</p> <p>Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access); AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:</p><p align=""justify"">(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,</p><p align=""justify"">(ii) Proximal weakness,</p><p align=""justify"">(iii) Hypotonia,</p><p align=""justify"">(iv) Absence of deep tendon reflexes,</p><p align=""justify"">(v) Failure to gain weight appropriate for age,</p><p align=""justify"">(vi) Any active denervation or chronic neurogenic changes found on electromyography,</p><p align=""justify"">(vii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">In this authority application, confirm:</p><p align=""justify"">(1) the patient&apos;s medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy,</p><p align=""justify"">(2) which of the above (i to vii) (at least 1) were present during childhood,</p><p align=""justify"">(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spinal muscular atrophy (SMA)</p><br/><p>Initial PBS-subsidised treatment with this drug in an adult who did not initiate PBS subsidy with this drug during childhood</p><br/><p>Patient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; AND</p> <p>Patient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19th birthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS-subsidised); AND</p> <p>Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or</p> <p>Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND</p> <p>Patient must be undergoing initial PBS-subsidised treatment with this drug for untreated disease; or</p> <p>Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access); AND</p> <p>Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND</p> <p>The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or</p> <p>The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND</p> <p>Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.</p> <p align=""justify"">Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:</p><p align=""justify"">(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,</p><p align=""justify"">(ii) Proximal weakness,</p><p align=""justify"">(iii) Hypotonia,</p><p align=""justify"">(iv) Absence of deep tendon reflexes,</p><p align=""justify"">(v) Failure to gain weight appropriate for age,</p><p align=""justify"">(vi) Any active denervation or chronic neurogenic changes found on electromyography,</p><p align=""justify"">(vii) A compound muscle action potential below normative values for an age-matched child.</p> <p align=""justify"">In this authority application, confirm:</p><p align=""justify"">(1) the patient&apos;s medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy,</p><p align=""justify"">(2) which of the above (i to vii) (at least 1) were present during childhood,</p><p align=""justify"">(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18495_N","null","null","null","null","null","<p>Not for use in superficial mycoses</p>","Y","N","N","null","null","N","2016-04-01","N","4708"
"18496_18496_R","Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis), Initial 2: New patient (commencing from National Blood Authority-funded C1-INH) or Initial 3: New patient (transitioning from PBS-subsidised lanadelumab) - balance of supply","AUTHORITY_REQUIRED","18496","18496","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis), Initial 2: New patient (commencing from National Blood Authority-funded C1-INH) or Initial 3: New patient (transitioning from PBS-subsidised lanadelumab) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2: New patient (commencing from National Blood Authority-funded C1-INH) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3: New patient (transitioning from PBS-subsidised lanadelumab) restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist.</p> <p align=""justify"">For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient&apos;s medical records for auditing purposes.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis), Initial 2: New patient (commencing from National Blood Authority-funded C1-INH) or Initial 3: New patient (transitioning from PBS-subsidised lanadelumab) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2: New patient (commencing from National Blood Authority-funded C1-INH) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3: New patient (transitioning from PBS-subsidised lanadelumab) restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist.</p> <p align=""justify"">For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient&apos;s medical records for auditing purposes.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18497_18140_R","Initial 2: New patient (commencing from National Blood Authority-funded C1-INH)","AUTHORITY_REQUIRED","18140","18497","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 2: New patient (commencing from National Blood Authority-funded C1-INH)</p><br/><p>Patient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving lanadelumab; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist; AND</p> <p>Patient must be aged 12 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic treatment of hereditary angioedema Types 1 or 2</p><br/><p>Initial 2: New patient (commencing from National Blood Authority-funded C1-INH)</p><br/><p>Patient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving lanadelumab; AND</p> <p>The treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab; AND</p> <p>Must be treated by a clinical immunologist or a specialist allergist; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18501_18491_R","Initial treatment","AUTHORITY_REQUIRED","18491","18501","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myelomonocytic Leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; AND</p> <p>The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder.</p> <p align=""justify"">No more than 3 cycles will be authorised under this restriction in a patient&apos;s lifetime.</p> <p align=""justify"">The first authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and</p><p align=""justify"">(b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology Authority</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and</p><p align=""justify"">(b) full blood examination report</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic Myelomonocytic Leukaemia</p><br/><p>Initial treatment</p><br/><p>The condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; AND</p> <p>The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder.</p> <p align=""justify"">No more than 3 cycles will be authorised under this restriction in a patient&apos;s lifetime.</p> <p align=""justify"">The first authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and</p><p align=""justify"">(b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology Authority</p><p align=""justify"">All reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following reports must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and</p><p align=""justify"">(b) full blood examination report</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 888 333.</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">PBS Authorities</p><p align=""justify"">GPO Box 9826</p><p align=""justify"">[Your capital city]</p>","N","N","N","FULL","ALL","N","2026-04-01","Y","4708"
"18504_18480_R","Initial treatment","AUTHORITY_REQUIRED","18480","18504","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Amyotrophic lateral sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be/have been diagnosed by a neurologist; AND</p> <p>Patient must not have had symptoms for more than 2 years prior to commencing therapy with this drug; AND</p> <p>Patient must have at least 80 percent of predicted forced vital capacity (FVC) or slow vital capacity (SVC) within the 2 months prior to commencing therapy with this drug; AND</p> <p>Patient must not require assistance with eating or ambulation prior to commencing treatment with this drug; AND</p> <p>Patient must have at least two points on each individual item of the ALS Functional Rating Scale - Revised (ALSFRS-R) score prior to commencing therapy with this drug; AND</p> <p>Patient must not have undergone a tracheostomy; AND</p> <p>Patient must not have experienced respiratory failure.</p> <p align=""justify"">The date of diagnosis, the date and results of spirometry (in terms of percent of predicted forced vital capacity or slow vital capacity) must be supplied with the initial authority application.</p> <p align=""justify"">Prescribers must request a quantity sufficient to cover one month per dispensing, in accordance with the patient&apos;s treatment cycle. Prescribers must request a smaller number of units than the listed maximum quantity units if it is adequate for the patient&apos;s needs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Amyotrophic lateral sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be/have been diagnosed by a neurologist; AND</p> <p>Patient must not have had symptoms for more than 2 years prior to commencing therapy with this drug; AND</p> <p>Patient must have at least 80 percent of predicted forced vital capacity (FVC) or slow vital capacity (SVC) within the 2 months prior to commencing therapy with this drug; AND</p> <p>Patient must not require assistance with eating or ambulation prior to commencing treatment with this drug; AND</p> <p>Patient must have at least two points on each individual item of the ALS Functional Rating Scale - Revised (ALSFRS-R) score prior to commencing therapy with this drug; AND</p> <p>Patient must not have undergone a tracheostomy; AND</p> <p>Patient must not have experienced respiratory failure.</p> <p align=""justify"">The date of diagnosis, the date and results of spirometry (in terms of percent of predicted forced vital capacity or slow vital capacity) must be supplied with the initial authority application.</p> <p align=""justify"">Prescribers must request a quantity sufficient to cover one month per dispensing, in accordance with the patient&apos;s treatment cycle. Prescribers must request a smaller number of units than the listed maximum quantity units if it is adequate for the patient&apos;s needs.</p> <p align=""justify"">Patients who are receiving non-PBS-subsidised treatment with this drug (Grandfathered patients) may transition to PBS-subsidised treatment through the initial treatment phase, provided they met the eligibility criteria at the time treatment was commenced. To continue PBS-subsidised treatment, after accessing the initial PBS-subsided therapy, a Grandfathered patient must qualify under the continuing treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-04-01","N","4708"
"18506_18513_R","null","STREAMLINED","18513","18506","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Deep vein thrombosis</p><br/><p>Patient must have confirmed acute symptomatic deep vein thrombosis; AND</p> <p>Patient must not have symptomatic pulmonary embolism.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Deep vein thrombosis</p><br/><p>Patient must have confirmed acute symptomatic deep vein thrombosis; AND</p> <p>Patient must not have symptomatic pulmonary embolism.</p>","N","N","N","IMMEDIATE","ALL","N","2026-05-01","N","4708"
"18509_18507_R","null","RESTRICTED","18507","18509","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bipolar disorder</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bipolar disorder</p><br/><p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2026-05-01","N","4708"
"18510_18515_R","Initial treatment","STREAMLINED","18515","18510","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction</p><br/><p>Initial treatment</p><br/><p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must have previously received at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum and either a taxane or irinotecan; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">The patient&apos;s WHO performance status and body weight must be documented in the patient&apos;s medical records at the time the treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction</p><br/><p>Initial treatment</p><br/><p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must have previously received at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum and either a taxane or irinotecan; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">The patient&apos;s WHO performance status and body weight must be documented in the patient&apos;s medical records at the time the treatment is initiated.</p>","N","N","N","IMMEDIATE","ALL","N","2026-05-01","N","4708"
"18512_18527_R","null","STREAMLINED","18527","18512","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary embolism</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have confirmed acute symptomatic pulmonary embolism.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary embolism</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have confirmed acute symptomatic pulmonary embolism.</p>","N","N","N","IMMEDIATE","ALL","N","2026-05-01","N","4708"
"18514_18520_R","Continuing treatment","STREAMLINED","18520","18514","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2026-05-01","N","4708"
"18515_N","null","null","null","null","null","<p align=""justify"">A proportion of patients respond to 150 mg 4-weekly so where a substantial improvement has been obtained with a 300 mg dose it is reasonable to back-titrate dose after initial treatment.</p>","Y","N","N","null","null","N","2017-09-01","N","4708"
"18517_18518_R","Initial treatment","STREAMLINED","18518","18517","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must have been previously treated with or not considered a candidate for treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-vascular endothelial growth factor (anti-VEGF) agent and an anti-epidermal growth factor receptor (anti-EGFR) agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">The patient&apos;s WHO performance status and body weight must be documented in the patient&apos;s medical records at the time the treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have a WHO performance status of 1 or less; AND</p> <p>Patient must have been previously treated with or not considered a candidate for treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-vascular endothelial growth factor (anti-VEGF) agent and an anti-epidermal growth factor receptor (anti-EGFR) agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">The patient&apos;s WHO performance status and body weight must be documented in the patient&apos;s medical records at the time the treatment is initiated.</p>","N","N","N","IMMEDIATE","ALL","N","2026-05-01","N","4708"
"18519_18525_R","null","STREAMLINED","18525","18519","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Deep vein thrombosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have confirmed acute symptomatic deep vein thrombosis; AND</p> <p>Patient must not have symptomatic pulmonary embolism.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Deep vein thrombosis</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have confirmed acute symptomatic deep vein thrombosis; AND</p> <p>Patient must not have symptomatic pulmonary embolism.</p>","N","N","N","IMMEDIATE","ALL","N","2026-05-01","N","4708"
"18521_18522_R","null","STREAMLINED","18522","18521","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary embolism</p><br/><p>Patient must have confirmed acute symptomatic pulmonary embolism.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary embolism</p><br/><p>Patient must have confirmed acute symptomatic pulmonary embolism.</p>","N","N","N","IMMEDIATE","ALL","N","2026-05-01","N","4708"
"18523_18508_R","null","RESTRICTED","18508","18523","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bipolar disorder</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bipolar disorder</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2026-05-01","N","4708"
"18528_18647_R","Initial treatment - Initial 1, Face, hand, foot (new patient)","AUTHORITY_REQUIRED","18647","18528","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18531_18562_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","18562","18531","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18532_18584_R","Balance of supply - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","18584","18532","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Balance of supply - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Balance of supply - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18533_18534_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","18534","18533","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18536_18542_R","First continuing treatment, Whole body","AUTHORITY_REQUIRED","18542","18536","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18539_18543_R","Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18543","18539","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify""><b>Prescribing the 80 mg presentation:</b></p><p align=""justify"">Two completed authority prescriptions may be submitted with every initial application for this biological medicine. One prescription for an induction dose of 80 mg and no repeats and the second prescription for 2 doses of 40 mg and 3 repeats.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18541_18547_R","First continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","18547","18541","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet and the face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet and the face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18546_18537_R","Balance of supply - Continuing treatment, Whole body or Continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","18537","18546","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Continuing treatment, Whole body or Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Continuing treatment, Whole body or Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18548_18543_R","Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18543","18548","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18551_18594_R","Balance of supply - Continuing treatment","AUTHORITY_REQUIRED","18594","18551","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Balance of supply - Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Balance of supply - Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18553_18557_R","Balance of supply - Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","18557","18553","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Balance of supply - Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Balance of supply - Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18554_18552_R","First continuing treatment","AUTHORITY_REQUIRED","18552","18554","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18555_18631_R","Subsequent continuing treatment","AUTHORITY_REQUIRED","18631","18555","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient doses for up to 24 weeks treatment. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient doses for up to 24 weeks treatment. Up to a maximum of 5 repeats will be authorised.</p> <p align=""justify"">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18556_18593_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","18593","18556","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measurements must be no more than 4 weeks old at the time of initial application.</p><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18558_18695_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","18695","18558","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18559_18598_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","18598","18559","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18561_18604_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","18604","18561","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18563_18601_R","Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)","AUTHORITY_REQUIRED","18601","18563","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.</p> <p align=""justify"">If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.</p> <p align=""justify"">If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","N","N","N","FULL","ALL","N","2026-06-01","Y","4708"
"18564_18697_R","Balance of supply - Continuing treatment","AUTHORITY_REQUIRED","18697","18564","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Balance of supply - Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Balance of supply - Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18566_18639_R","Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)","AUTHORITY_REQUIRED","18639","18566","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.</p> <p align=""justify"">If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.</p> <p align=""justify"">If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.</p> <p/><p align=""justify"">An adequate response to treatment is defined as:</p><p/><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or </p><p/><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p/><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p/><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p><p/> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)</p><br/><p>Must be treated by a paediatric rheumatologist; or</p> <p>Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND</p> <p>Patient must be under 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.</p> <p align=""justify"">If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.</p> <p align=""justify"">If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.</p> <p/><p align=""justify"">An adequate response to treatment is defined as:</p><p/><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or </p><p/><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p/><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p/><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p><p/> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","FULL","ALL","N","2026-06-01","Y","4708"
"18567_18671_R","First continuing treatment","AUTHORITY_REQUIRED","18671","18567","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18568_18643_R","Initial treatment - Initial 1, Face, hand, foot (new patient)","AUTHORITY_REQUIRED","18643","18568","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18569_18571_R","Continuing treatment, Whole body","AUTHORITY_REQUIRED","18571","18569","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18570_18530_R","Balance of supply - Continuing treatment, Whole body or Continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","18530","18570","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Continuing treatment, Whole body or Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Continuing treatment, Whole body or Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18572_18662_R","Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made","AUTHORITY_REQUIRED","18662","18572","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made</p><br/><p>Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND</p> <p>Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS administrator will confirm that:</p><p align=""justify"">(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;</p><p align=""justify"">(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made</p><br/><p>Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND</p> <p>Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS administrator will confirm that:</p><p align=""justify"">(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;</p><p align=""justify"">(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.</p>","N","N","N","FULL","ALL","N","2026-06-01","Y","4708"
"18573_18653_R","Initial treatment - Initial 1, Whole body (new patient)","AUTHORITY_REQUIRED","18653","18573","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18574_18701_R","Continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","18701","18574","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18577_18680_R","Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18680","18577","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18578_18651_R","Induction treatment - balance of supply - relapsed or refractory B-precursor cell ALL","AUTHORITY_REQUIRED","18651","18578","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Induction treatment - balance of supply - relapsed or refractory B-precursor cell ALL</p><br/><p>The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND</p> <p>The condition must not be present in the central nervous system or testis; AND</p> <p>Patient must have received insufficient therapy with this agent for this condition under the Induction treatment restriction to complete a maximum of 2 treatment cycles in a lifetime.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.</p> <p align=""justify"">An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.</p> <p align=""justify"">Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Careful monitoring of patients is required due to risk of developing life-threatening Cytokine Release Syndrome, neurological toxicities and reactivation of John Cunningham virus (JC) viral infection.</p> <p>Acute lymphoblastic leukaemia</p><br/><p>Induction treatment - balance of supply - relapsed or refractory B-precursor cell ALL</p><br/><p>The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND</p> <p>The condition must not be present in the central nervous system or testis; AND</p> <p>Patient must have received insufficient therapy with this agent for this condition under the Induction treatment restriction to complete a maximum of 2 treatment cycles in a lifetime.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.</p> <p align=""justify"">An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.</p> <p align=""justify"">Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18580_18579_R","Consolidation treatment of relapsed or refractory B-precursor cell ALL","AUTHORITY_REQUIRED","18579","18580","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Consolidation treatment of relapsed or refractory B-precursor cell ALL</p><br/><p>Patient must have previously received PBS-subsidised induction treatment with this drug for relapsed or refractory B-precursor cell ALL; AND</p> <p>Patient must have achieved a complete remission; or</p> <p>Patient must have achieved a complete remission with partial haematological recovery; AND</p> <p>The treatment must not be more than 3 treatment cycles under this restriction in a lifetime; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Careful monitoring of patients is required due to risk of developing life-threatening Cytokine Release Syndrome, neurological toxicities and reactivation of John Cunningham virus (JC) viral infection.</p> <p>Acute lymphoblastic leukaemia</p><br/><p>Consolidation treatment of relapsed or refractory B-precursor cell ALL</p><br/><p>Patient must have previously received PBS-subsidised induction treatment with this drug for relapsed or refractory B-precursor cell ALL; AND</p> <p>Patient must have achieved a complete remission; or</p> <p>Patient must have achieved a complete remission with partial haematological recovery; AND</p> <p>The treatment must not be more than 3 treatment cycles under this restriction in a lifetime; AND</p> <p>Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.</p> <p align=""justify"">A complete remission is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a full recovery of peripheral blood counts with platelets of greater than 100,000 per microliter, and absolute neutrophil count (ANC) of greater than 1,000 per microliter.</p> <p align=""justify"">A complete remission with partial haematological recovery is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a partial recovery of peripheral blood counts with platelets of greater than 50,000 per microliter, and absolute neutrophil count (ANC) of greater than 500 per microliter.</p> <p align=""justify"">Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time when an assessment is required must cease PBS-subsidised therapy with this agent.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18581_18709_R","Induction treatment (step-up dosing)","AUTHORITY_REQUIRED","18709","18581","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory multiple myeloma</p><br/><p>Induction treatment (step-up dosing)</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must have progressive disease after receiving at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, and (iii) an anti-CD38 monoclonal antibody; or</p> <p>Patient must be refractory to, at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, (iii) an anti-CD38 monoclonal antibody; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must not have previously received treatment with another B-cell maturation antigen (BCMA) directed therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose.</p> <p align=""justify"">Patients who require restarting therapy due to dose delays may access step-up dosing through this induction treatment restriction.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p><p align=""justify"">Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p><p align=""justify"">Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient&apos;s medical records.</p><p align=""justify"">Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient&apos;s medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient&apos;s medical records.</p><p align=""justify"">Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory multiple myeloma</p><br/><p>Induction treatment (step-up dosing)</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>Patient must have progressive disease after receiving at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, and (iii) an anti-CD38 monoclonal antibody; or</p> <p>Patient must be refractory to, at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, (iii) an anti-CD38 monoclonal antibody; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must not have previously received treatment with another B-cell maturation antigen (BCMA) directed therapy for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose.</p> <p align=""justify"">Patients who require restarting therapy due to dose delays may access step-up dosing through this induction treatment restriction.</p> <p align=""justify"">This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">Progressive disease is defined as at least 1 of the following:</p><p align=""justify"">(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or</p><p align=""justify"">(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or</p><p align=""justify"">(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or</p><p align=""justify"">(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or</p><p align=""justify"">(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or</p><p align=""justify"">(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).</p><p align=""justify"">Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.</p><p align=""justify"">Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient&apos;s medical records.</p><p align=""justify"">Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) the level of serum monoclonal protein; or</p><p align=""justify"">(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or</p><p align=""justify"">(c) the serum level of free kappa and lambda light chains; or</p><p align=""justify"">(d) bone marrow aspirate or trephine; or</p><p align=""justify"">(e) if present, the size and location of lytic bone lesions (not including compression fractures); or</p><p align=""justify"">(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or</p><p align=""justify"">(g) if present, the level of hypercalcaemia, corrected for albumin concentration.</p><p align=""justify"">As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient&apos;s medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient&apos;s medical records.</p><p align=""justify"">Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18585_18535_R","Initial treatment - Initial 1, Face, hand, foot (new patient)","AUTHORITY_REQUIRED","18535","18585","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify""><b>Prescribing the 80 mg presentation:</b></p><p align=""justify"">Two completed authority prescriptions may be submitted with every initial application for this biological medicine. One prescription for an induction dose of 80 mg and no repeats and the second prescription for 2 doses of 40 mg and 3 repeats.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18586_18540_R","Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18540","18586","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify""><b>Prescribing the 80 mg presentation:</b></p><p align=""justify"">Two completed authority prescriptions may be submitted with every initial application for this biological medicine. One prescription for an induction dose of 80 mg and no repeats and the second prescription for 2 doses of 40 mg and 3 repeats.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18588_18669_R","Subsequent continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","18669","18588","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet and the face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet and the face, hand, foot area diagrams including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18589_18587_R","Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18587","18589","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify""><b>Prescribing the 80 mg presentation:</b></p><p align=""justify"">Two completed authority prescriptions may be submitted with every initial application for this biological medicine. One prescription for an induction dose of 80 mg and no repeats and the second prescription for 2 doses of 40 mg and 3 repeats.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18591_18538_R","Subsequent continuing treatment, Whole body","AUTHORITY_REQUIRED","18538","18591","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18592_18545_R","Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18545","18592","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18595_18550_R","Initial treatment - Initial 2 (change or recommencement of treatment after break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","18550","18595","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18597_18634_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","18634","18597","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18599_18635_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","18635","18599","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient&apos;s weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.</p> <p align=""justify"">Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.</p> <p align=""justify"">Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient&apos;s weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.</p> <p align=""justify"">Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18600_18560_R","First continuing treatment","AUTHORITY_REQUIRED","18560","18600","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18602_18711_R","Continuing treatment","AUTHORITY_REQUIRED","18711","18602","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18603_18691_R","Balance of supply - first continuing treatment","AUTHORITY_REQUIRED","18691","18603","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Balance of supply - first continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Balance of supply - first continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18605_18672_R","Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18672","18605","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18606_18698_R","Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18698","18606","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18607_18583_R","Continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","18583","18607","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18609_18610_R","Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18610","18609","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18611_18582_R","Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18582","18611","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18612_18704_R","Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18704","18612","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18613_18717_R","Initial treatment - Initial 1, Face, hand, foot (new patient)","AUTHORITY_REQUIRED","18717","18613","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18615_18615_R","Initial treatment (treatment cycles 1 to 2 inclusive) in first-line therapy","AUTHORITY_REQUIRED","18615","18615","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Initial treatment (treatment cycles 1 to 2 inclusive) in first-line therapy</p><br/><p>The condition must be untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be initiated as monotherapy, with the intention of use in combination with venetoclax from cycle 3 to 14; AND</p> <p>The treatment must not be in combination with obinutuzumab.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Initial treatment (treatment cycles 1 to 2 inclusive) in first-line therapy</p><br/><p>The condition must be untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be initiated as monotherapy, with the intention of use in combination with venetoclax from cycle 3 to 14; AND</p> <p>The treatment must not be in combination with obinutuzumab.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18616_18685_R","For combination use with venetoclax treatment cycles 1 to 6 inclusive in first-line therapy","STREAMLINED","18685","18616","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>For combination use with venetoclax treatment cycles 1 to 6 inclusive in first-line therapy</p><br/><p>The condition must be untreated; AND</p> <p>The treatment must be in combination with PBS-subsidised venetoclax; AND</p> <p>The treatment must not be in combination with acalabrutinib.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>For combination use with venetoclax treatment cycles 1 to 6 inclusive in first-line therapy</p><br/><p>The condition must be untreated; AND</p> <p>The treatment must be in combination with PBS-subsidised venetoclax; AND</p> <p>The treatment must not be in combination with acalabrutinib.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18617_18618_R","For combination use with acalabrutinib from treatment cycles 2 to 7 inclusive in first-line therapy","STREAMLINED","18618","18617","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>For combination use with acalabrutinib from treatment cycles 2 to 7 inclusive in first-line therapy</p><br/><p>The condition must be untreated; AND</p> <p>The treatment must be in combination with PBS-subsidised acalabrutinib (refer to Product Information for timing of obinutuzumab and acalabrutinib doses); AND</p> <p>The treatment must not be in combination with venetoclax.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>For combination use with acalabrutinib from treatment cycles 2 to 7 inclusive in first-line therapy</p><br/><p>The condition must be untreated; AND</p> <p>The treatment must be in combination with PBS-subsidised acalabrutinib (refer to Product Information for timing of obinutuzumab and acalabrutinib doses); AND</p> <p>The treatment must not be in combination with venetoclax.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18619_18516_R","Initial PBS-subsidised treatment","STREAMLINED","18516","18619","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial PBS-subsidised treatment</p><br/><p>Patient must have/had a WHO performance status of 1 or less, prior to initiation of treatment with this drug for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; or</p> <p>Patient must be each of: (i) currently receiving non-PBS-subsidised supply for this drug for this PBS indication, (ii) untreated with this drug at the time that non-PBS-subsidised supply was commenced, (iii) free of disease progression since commencing non-PBS-subsidised supply; AND</p> <p>Patient must have been previously treated with or not considered a candidate for treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-vascular endothelial growth factor (anti-VEGF) agent and an anti-epidermal growth factor receptor (anti-EGFR) agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">The patient&apos;s WHO performance status must be documented in the patient&apos;s medical records at the time the treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial PBS-subsidised treatment</p><br/><p>Patient must have/had a WHO performance status of 1 or less, prior to initiation of treatment with this drug for this condition; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; or</p> <p>Patient must be each of: (i) currently receiving non-PBS-subsidised supply for this drug for this PBS indication, (ii) untreated with this drug at the time that non-PBS-subsidised supply was commenced, (iii) free of disease progression since commencing non-PBS-subsidised supply; AND</p> <p>Patient must have been previously treated with or not considered a candidate for treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-vascular endothelial growth factor (anti-VEGF) agent and an anti-epidermal growth factor receptor (anti-EGFR) agent for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">The patient&apos;s WHO performance status must be documented in the patient&apos;s medical records at the time the treatment is initiated.</p> <p align=""justify"">A patient may only qualify for PBS-subsidised treatment under this restriction once. Following completion of the initial PBS-subsidised course, further applications for treatment will be assessed under the continuing treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18620_18650_R","Initial treatment of newly-diagnosed Pre-B-cell ALL in the consolidation phase","AUTHORITY_REQUIRED","18650","18620","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)</p><br/><p>Initial treatment of newly-diagnosed Pre-B-cell ALL in the consolidation phase</p><br/><p>Must be treated by a physician experienced in the treatment of haematological malignancies; AND</p> <p>Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND</p> <p>The condition must not be present in the central nervous system or testis; AND</p> <p>Patient must have achieved complete remission following intensive combination chemotherapy for acute lymphoblastic leukaemia (ALL); or</p> <p>Patient must have Philadelphia chromosome positive ALL, and both (i) have achieved complete remission following combination therapy with a tyrosine kinase inhibitor and corticosteroids (ii) be unable to tolerate chemotherapy; AND</p> <p>The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 days of the first cycle and the first 2 days of the second cycle. </p> <p align=""justify"">For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.</p> <p align=""justify"">An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.</p> <p align=""justify"">Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Acute Lymphoblastic Leukaemia in complete haematological remission PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">(3) the percentage blasts in bone marrow count measured that is no more than 4 weeks old at the time of application; and</p><p align=""justify"">(4) the date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; or</p><p align=""justify"">(5) the date of the course of combination therapy with a tyrosine kinase inhibitor and corticosteroid for Philadelphia chromosome positive patients.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)</p><br/><p>Initial treatment of newly-diagnosed Pre-B-cell ALL in the consolidation phase</p><br/><p>Must be treated by a physician experienced in the treatment of haematological malignancies; AND</p> <p>Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND</p> <p>The condition must not be present in the central nervous system or testis; AND</p> <p>Patient must have achieved complete remission following intensive combination chemotherapy for acute lymphoblastic leukaemia (ALL); or</p> <p>Patient must have Philadelphia chromosome positive ALL, and both (i) have achieved complete remission following combination therapy with a tyrosine kinase inhibitor and corticosteroids (ii) be unable to tolerate chemotherapy; AND</p> <p>The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 days of the first cycle and the first 2 days of the second cycle. </p> <p align=""justify"">For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.</p> <p align=""justify"">An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.</p> <p align=""justify"">Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Acute Lymphoblastic Leukaemia in complete haematological remission PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">(3) the percentage blasts in bone marrow count measured that is no more than 4 weeks old at the time of application; and</p><p align=""justify"">(4) the date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; or</p><p align=""justify"">(5) the date of the course of combination therapy with a tyrosine kinase inhibitor and corticosteroid for Philadelphia chromosome positive patients.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18622_18623_R","null","STREAMLINED","18623","18622","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic kidney disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of: (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug; AND</p> <p>Patient must have an estimated glomerular filtration rate of between 20 to 90 mL/min/1.73 m2 inclusive prior to initiating treatment with this drug; AND</p> <p>Patient must have an estimated glomerular filtration rate of between 45 to 90 mL/min/1.73 m2 inclusive, with a urinary albumin to creatinine ratio of at least 200 mg/g (22.6 mg/mmol) prior to initiating treatment with this drug; or</p> <p>Patient must have an estimated glomerular filtration rate of between 20 to 45 mL/min/1.73 m2 inclusive, with any level of urinary albumin to creatinine ratio prior to initiating treatment with this drug; AND</p> <p>Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant; AND</p> <p>Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND</p> <p>Patient must be stabilised, for at least 4 weeks, on either: (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug.</p> <p align=""justify"">Patients with polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis; patients requiring or with a recent history of cytotoxic or immunosuppressive therapy for kidney disease; and patients with an organ transplant are not eligible for treatment with this drug.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic kidney disease</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of: (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug; AND</p> <p>Patient must have an estimated glomerular filtration rate of between 20 to 90 mL/min/1.73 m2 inclusive prior to initiating treatment with this drug; AND</p> <p>Patient must have an estimated glomerular filtration rate of between 45 to 90 mL/min/1.73 m2 inclusive, with a urinary albumin to creatinine ratio of at least 200 mg/g (22.6 mg/mmol) prior to initiating treatment with this drug; or</p> <p>Patient must have an estimated glomerular filtration rate of between 20 to 45 mL/min/1.73 m2 inclusive, with any level of urinary albumin to creatinine ratio prior to initiating treatment with this drug; AND</p> <p>Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant; AND</p> <p>Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND</p> <p>Patient must be stabilised, for at least 4 weeks, on either: (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug.</p> <p align=""justify"">Patients with polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis; patients requiring or with a recent history of cytotoxic or immunosuppressive therapy for kidney disease; and patients with an organ transplant are not eligible for treatment with this drug.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18626_18529_R","Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18529","18626","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18627_18544_R","Initial treatment - Initial 1, Whole body (new patient)","AUTHORITY_REQUIRED","18544","18627","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify""><b>Prescribing the 80 mg presentation:</b></p><p align=""justify"">Two completed authority prescriptions may be submitted with every initial application for this biological medicine. One prescription for an induction dose of 80 mg and no repeats and the second prescription for 2 doses of 40 mg and 3 repeats.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18628_18545_R","Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18545","18628","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify""><b>Prescribing the 80 mg presentation:</b></p><p align=""justify"">Two completed authority prescriptions may be submitted with every initial application for this biological medicine. One prescription for an induction dose of 80 mg and no repeats and the second prescription for 2 doses of 40 mg and 3 repeats.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18629_18590_R","Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18590","18629","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18630_18549_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","18549","18630","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; or</p> <p>Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Active joints are defined as:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measurements must be no more than 4 weeks old at the time of this application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; or</p> <p>Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Active joints are defined as:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measurements must be no more than 4 weeks old at the time of this application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18632_18633_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","18633","18632","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient&apos;s weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.</p> <p align=""justify"">Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.</p> <p align=""justify"">The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:</p><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either</p><p align=""justify"">(a) a total active joint count of at least 20 active (swollen and tender) joints; or</p><p align=""justify"">(b) at least 4 active joints from the following list of major joints:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient&apos;s weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.</p> <p align=""justify"">Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18636_18659_R","Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made","AUTHORITY_REQUIRED","18659","18636","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made</p><br/><p>Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND</p> <p>Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS administrator will confirm that:</p><p align=""justify"">(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;</p><p align=""justify"">(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made</p><br/><p>Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND</p> <p>Patient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The PBS administrator will confirm that:</p><p align=""justify"">(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;</p><p align=""justify"">(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.</p>","N","N","N","FULL","ALL","N","2026-06-01","Y","4708"
"18637_18696_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","18696","18637","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.</p> <p/><p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p/><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either </p><p/><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p/><p align=""justify"">(b) at least 4 active joints from the following list:</p><p/><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p/><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p><p/><p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. </p><p/><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; or</p> <p>Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or</p> <p>Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.</p><p align=""justify"">The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.</p><p align=""justify"">The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.</p><p align=""justify"">If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.</p> <p/><p align=""justify"">The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p/><p align=""justify"">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either </p><p/><p align=""justify"">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p/><p align=""justify"">(b) at least 4 active joints from the following list:</p><p/><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p/><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p><p/><p align=""justify"">The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. </p><p/><p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An assessment of a patient&apos;s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted for the following purposes:</p><p align=""justify"">(a) exempting a patient from the requirement to undertake a minimum 3 month trial of methotrexate at a 20 mg weekly dose;</p><p align=""justify"">(b) substituting azathioprine, cyclosporin or sodium aurothiomalate for another DMARD as part of the 6 month intensive DMARD trial;</p><p align=""justify"">(c) exempting a patient from the requirement for a 6 month trial of intensive DMARD therapy.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18640_18608_R","Initial treatment - Initial 1, Whole body (new patient)","AUTHORITY_REQUIRED","18608","18640","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18641_18692_R","Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18692","18641","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18642_18713_R","Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18713","18642","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18648_18648_R","First continuing treatment (treatment cycles 4 to 8 inclusive) of first-line therapy with acalabrutinib","AUTHORITY_REQUIRED","18648","18648","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First continuing treatment (treatment cycles 4 to 8 inclusive) of first-line therapy with acalabrutinib</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with acalabrutinib; AND</p> <p>The treatment must not be in combination with obinutuzumab; AND</p> <p>The treatment must cease upon disease progression.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First continuing treatment (treatment cycles 4 to 8 inclusive) of first-line therapy with acalabrutinib</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with acalabrutinib; AND</p> <p>The treatment must not be in combination with obinutuzumab; AND</p> <p>The treatment must cease upon disease progression.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18649_18688_R","Continuing treatment of Pre-B-cell ALL in complete haematological remission (CR)","AUTHORITY_REQUIRED","18688","18649","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)</p><br/><p>Continuing treatment of Pre-B-cell ALL in complete haematological remission (CR)</p><br/><p>Must be treated by a physician experienced in the treatment of haematological malignancies; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved a complete remission; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.</p> <p align=""justify"">For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.</p> <p align=""justify"">An amount of 784 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.</p> <p align=""justify"">Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)</p><br/><p>Continuing treatment of Pre-B-cell ALL in complete haematological remission (CR)</p><br/><p>Must be treated by a physician experienced in the treatment of haematological malignancies; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved a complete remission; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.</p> <p align=""justify"">For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.</p> <p align=""justify"">An amount of 784 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.</p> <p align=""justify"">Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18652_18625_R","First continuing treatment (until at least 6 months on optimal dose is achieved)","AUTHORITY_REQUIRED","18625","18652","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic obstructive hypertrophic cardiomyopathy</p><br/><p>First continuing treatment (until at least 6 months on optimal dose is achieved)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction; AND</p> <p>Patient must be undergoing concomitant treatment with at least one of: (i) a beta-blocker (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy; AND</p> <p>Patient must have a current left ventricular ejection fraction (LVEF) of no less than 50%; AND</p> <p>Patient must be titrating mavacamten treatment until optimal dose is achieved; or</p> <p>Patient must be continuing mavacamten treatment to reach at least 6 months on the optimal dose prior to assessing the response; AND</p> <p>Must be treated by a cardiologist; or</p> <p>Must be treated by a consultant physician with experience in the management of hypertrophic cardiomyopathy.</p> <p align=""justify"">The assessment of response must be conducted after at least 6 months on optimal dose to determine the patient&apos;s eligibility for maintenance treatment. Where an assessment is not undertaken, the patient will not be eligible for ongoing treatment. This treatment phase listing intends to provide up to 36 weeks of treatment in 3 treatment courses.</p> <p align=""justify"">For the purposes of this restriction, an adequate response to treatment is defined as: an improvement in at least one of the following: (i) symptoms, (ii) quality of life, (iii) exercise capacity, (iv) peak left ventricular outflow tract (LVOT) gradient.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Symptomatic obstructive hypertrophic cardiomyopathy</p><br/><p>First continuing treatment (until at least 6 months on optimal dose is achieved)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction; AND</p> <p>Patient must be undergoing concomitant treatment with at least one of: (i) a beta-blocker (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy; AND</p> <p>Patient must have a current left ventricular ejection fraction (LVEF) of no less than 50%; AND</p> <p>Patient must be titrating mavacamten treatment until optimal dose is achieved; or</p> <p>Patient must be continuing mavacamten treatment to reach at least 6 months on the optimal dose prior to assessing the response; AND</p> <p>Must be treated by a cardiologist; or</p> <p>Must be treated by a consultant physician with experience in the management of hypertrophic cardiomyopathy.</p> <p align=""justify"">The assessment of response must be conducted after at least 6 months on optimal dose to determine the patient&apos;s eligibility for maintenance treatment. Where an assessment is not undertaken, the patient will not be eligible for ongoing treatment. This treatment phase listing intends to provide up to 36 weeks of treatment in 3 treatment courses.</p> <p align=""justify"">For the purposes of this restriction, an adequate response to treatment is defined as: an improvement in at least one of the following: (i) symptoms, (ii) quality of life, (iii) exercise capacity, (iv) peak left ventricular outflow tract (LVOT) gradient.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18654_18587_R","Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18587","18654","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18655_18540_R","Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18540","18655","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18656_18544_R","Initial treatment - Initial 1, Whole body (new patient)","AUTHORITY_REQUIRED","18544","18656","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18657_18535_R","Initial treatment - Initial 1, Face, hand, foot (new patient)","AUTHORITY_REQUIRED","18535","18657","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">An assessment of a patient&apos;s response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18658_18596_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","18596","18658","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient&apos;s weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.</p> <p align=""justify"">Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.</p> <p align=""justify"">If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.</p> <p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient&apos;s weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.</p> <p align=""justify"">Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18660_18670_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","18670","18660","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; or</p> <p>Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Active joints are defined as:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measurements must be no more than 4 weeks old at the time of this application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; or</p> <p>Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">Active joints are defined as:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measurements must be no more than 4 weeks old at the time of this application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18663_18677_R","Initial treatment - Initial 1, Face, hand, foot (new patient)","AUTHORITY_REQUIRED","18677","18663","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Face, hand, foot (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:</p><p align=""justify"">(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or</p><p align=""justify"">(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18666_18666_R","Initial treatment in first-line therapy with acalabrutinib - Dose titration (cycle 3)","AUTHORITY_REQUIRED","18666","18666","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Initial treatment in first-line therapy with acalabrutinib - Dose titration (cycle 3)</p><br/><p>The condition must be untreated with venetoclax at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be in combination with acalabrutinib; AND</p> <p>The treatment must not be in combination with obinutuzumab.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Initial treatment in first-line therapy with acalabrutinib - Dose titration (cycle 3)</p><br/><p>The condition must be untreated with venetoclax at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be in combination with acalabrutinib; AND</p> <p>The treatment must not be in combination with obinutuzumab.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18667_18667_R","Second and final continuing treatment (treatment cycles 9 to 14 inclusive) of first-line therapy with acalabrutinib","AUTHORITY_REQUIRED","18667","18667","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Second and final continuing treatment (treatment cycles 9 to 14 inclusive) of first-line therapy with acalabrutinib</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with acalabrutinib; AND</p> <p>The treatment must not be in combination with obinutuzumab; AND</p> <p>The treatment must not exceed 12 cycles in total with this drug, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Second and final continuing treatment (treatment cycles 9 to 14 inclusive) of first-line therapy with acalabrutinib</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with acalabrutinib; AND</p> <p>The treatment must not be in combination with obinutuzumab; AND</p> <p>The treatment must not exceed 12 cycles in total with this drug, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18673_18575_R","Initial treatment - Initial 1, Whole body (new patient)","AUTHORITY_REQUIRED","18575","18673","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18674_18576_R","Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18576","18674","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""left"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18675_18715_R","Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18715","18675","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18676_18664_R","Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18664","18676","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18678_18614_R","Initial treatment - Initial 1, Whole body (new patient)","AUTHORITY_REQUIRED","18614","18678","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 1, Whole body (new patient)</p><br/><p>Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.</p> <p align=""justify"">Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align=""justify"">Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.</p> <p align=""justify"">The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:</p><p align=""justify"">(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p><p align=""justify"">(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.</p><p align=""justify"">(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.</p> <p align=""justify"">Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18679_18681_R","Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","18681","18679","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:</p><p align=""justify"">(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior biological treatment, including dosage, date and duration of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18684_18684_R","Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised supply in first-line therapy","AUTHORITY_REQUIRED","18684","18684","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised supply in first-line therapy</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 June 2026; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The condition must have been untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line treatment of CLL/SLL prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be in combination with venetoclax as continuing treatment for this condition (treatment cycles 3 to 14 inclusive); or</p> <p>The treatment must be as monotherapy for initial treatment of this condition (treatment cycles 1 to 2 inclusive); AND</p> <p>The treatment must not be in combination with obinutuzumab; AND</p> <p>The treatment must not exceed 14 cycles in total with this drug, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first.</p> <p>A patient may qualify for PBS-subsidised treatment under this restriction once only.</p> <p align=""justify"">For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the next relevant treatment phase.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised supply in first-line therapy</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 June 2026; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND</p> <p>The condition must have been untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line treatment of CLL/SLL prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be in combination with venetoclax as continuing treatment for this condition (treatment cycles 3 to 14 inclusive); or</p> <p>The treatment must be as monotherapy for initial treatment of this condition (treatment cycles 1 to 2 inclusive); AND</p> <p>The treatment must not be in combination with obinutuzumab; AND</p> <p>The treatment must not exceed 14 cycles in total with this drug, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first.</p> <p>A patient may qualify for PBS-subsidised treatment under this restriction once only.</p> <p align=""justify"">For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the next relevant treatment phase.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18689_18661_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)","AUTHORITY_REQUIRED","18661","18689","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18690_18638_R","Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)","AUTHORITY_REQUIRED","18638","18690","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.</p> <p align=""justify"">If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND</p> <p>Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.</p> <p align=""justify"">If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align=""justify"">AND either of the following:</p><p align=""justify"">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align=""justify"">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align=""justify"">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>","N","N","N","FULL","ALL","N","2026-06-01","Y","4708"
"18693_18683_R","Initial treatment in first-line therapy - Dose titration (weeks 1 to 4 of a 5-week ramp-up schedule)","AUTHORITY_REQUIRED","18683","18693","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Initial treatment in first-line therapy - Dose titration (weeks 1 to 4 of a 5-week ramp-up schedule)</p><br/><p>The condition must be untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND</p> <p>The treatment must not be in combination with acalabrutinib.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Initial treatment in first-line therapy - Dose titration (weeks 1 to 4 of a 5-week ramp-up schedule)</p><br/><p>The condition must be untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND</p> <p>The treatment must not be in combination with acalabrutinib.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18694_18686_R","First line drug treatment of this indication - in combination with obinutuzumab","AUTHORITY_REQUIRED","18686","18694","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First line drug treatment of this indication - in combination with obinutuzumab</p><br/><p>The condition must be untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be initiated as a monotherapy for 1 Cycle with treatment in combination with obinutuzumab from Cycle 2 to 7 (refer to Product Information for timing of obinutuzumab and acalabrutinib doses) after which treatment must be monotherapy; AND</p> <p>The treatment must not be in combination with venetoclax; AND</p> <p>Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; or</p> <p>Patient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First line drug treatment of this indication - in combination with obinutuzumab</p><br/><p>The condition must be untreated with drug treatment at the time of the first dose of this drug; or</p> <p>Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND</p> <p>The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND</p> <p>The treatment must be initiated as a monotherapy for 1 Cycle with treatment in combination with obinutuzumab from Cycle 2 to 7 (refer to Product Information for timing of obinutuzumab and acalabrutinib doses) after which treatment must be monotherapy; AND</p> <p>The treatment must not be in combination with venetoclax; AND</p> <p>Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; or</p> <p>Patient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18699_18644_R","Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18644","18699","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18700_18645_R","Continuing treatment, Whole body","AUTHORITY_REQUIRED","18645","18700","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18702_18646_R","Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18646","18702","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18703_18682_R","Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18682","18703","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 28 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient&apos;s condition.</p> <p align=""justify"">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-06-01","Y","4708"
"18706_18706_R","Continuing treatment (treatment cycles 3 to 14 inclusive) of first-line therapy - in combination with venetoclax","AUTHORITY_REQUIRED","18706","18706","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Continuing treatment (treatment cycles 3 to 14 inclusive) of first-line therapy - in combination with venetoclax</p><br/><p>Patient must have previously received this drug as their most recent course of PBS-subsidised treatment for this condition; AND</p> <p>The treatment must not exceed 14 cycles in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND</p> <p>The treatment must be in combination with venetoclax; AND</p> <p>The treatment must not be in combination with obinutuzumab; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Continuing treatment (treatment cycles 3 to 14 inclusive) of first-line therapy - in combination with venetoclax</p><br/><p>Patient must have previously received this drug as their most recent course of PBS-subsidised treatment for this condition; AND</p> <p>The treatment must not exceed 14 cycles in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND</p> <p>The treatment must be in combination with venetoclax; AND</p> <p>The treatment must not be in combination with obinutuzumab; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18707_18687_R","First continuing treatment (treatment cycles 2 to 6 inclusive) of first-line therapy","AUTHORITY_REQUIRED","18687","18707","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First continuing treatment (treatment cycles 2 to 6 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND</p> <p>The treatment must not be in combination with acalabrutinib; AND</p> <p>The treatment must cease upon disease progression.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>First continuing treatment (treatment cycles 2 to 6 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND</p> <p>The treatment must not be in combination with acalabrutinib; AND</p> <p>The treatment must cease upon disease progression.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18708_18624_R","null","STREAMLINED","18624","18708","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic kidney disease</p><br/><p>Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of: (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug; AND</p> <p>Patient must have an estimated glomerular filtration rate of between 20 to 90 mL/min/1.73 m2 inclusive prior to initiating treatment with this drug; AND</p> <p>Patient must have an estimated glomerular filtration rate of between 45 to 90 mL/min/1.73 m2 inclusive, with a urinary albumin to creatinine ratio of at least 200 mg/g (22.6 mg/mmol) prior to initiating treatment with this drug; or</p> <p>Patient must have an estimated glomerular filtration rate of between 20 to 45 mL/min/1.73 m2 inclusive, with any level of urinary albumin to creatinine ratio prior to initiating treatment with this drug; AND</p> <p>Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant; AND</p> <p>Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND</p> <p>Patient must be stabilised, for at least 4 weeks, on either: (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug.</p> <p align=""justify"">Patients with polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis; patients requiring or with a recent history of cytotoxic or immunosuppressive therapy for kidney disease; and patients with an organ transplant are not eligible for treatment with this drug.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic kidney disease</p><br/><p>Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of: (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug; AND</p> <p>Patient must have an estimated glomerular filtration rate of between 20 to 90 mL/min/1.73 m2 inclusive prior to initiating treatment with this drug; AND</p> <p>Patient must have an estimated glomerular filtration rate of between 45 to 90 mL/min/1.73 m2 inclusive, with a urinary albumin to creatinine ratio of at least 200 mg/g (22.6 mg/mmol) prior to initiating treatment with this drug; or</p> <p>Patient must have an estimated glomerular filtration rate of between 20 to 45 mL/min/1.73 m2 inclusive, with any level of urinary albumin to creatinine ratio prior to initiating treatment with this drug; AND</p> <p>Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant; AND</p> <p>Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND</p> <p>Patient must be stabilised, for at least 4 weeks, on either: (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug.</p> <p align=""justify"">Patients with polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis; patients requiring or with a recent history of cytotoxic or immunosuppressive therapy for kidney disease; and patients with an organ transplant are not eligible for treatment with this drug.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18710_18565_R","Balance of supply - Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)","AUTHORITY_REQUIRED","18565","18710","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Balance of supply - Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Balance of supply - Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18712_18714_R","Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18714","18712","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18716_18705_R","Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","18705","18716","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Balance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18718_18665_R","Second and final continuing treatment prescription (treatment cycles 7 to 12 inclusive) of first-line therapy","AUTHORITY_REQUIRED","18665","18718","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Second and final continuing treatment prescription (treatment cycles 7 to 12 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must cease upon disease progression; or</p> <p>The treatment must cease upon completion of 12 cycles of treatment with this drug for this condition, whichever comes first; AND</p> <p>The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND</p> <p>The treatment must not be in combination with acalabrutinib.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)</p><br/><p>Second and final continuing treatment prescription (treatment cycles 7 to 12 inclusive) of first-line therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must cease upon disease progression; or</p> <p>The treatment must cease upon completion of 12 cycles of treatment with this drug for this condition, whichever comes first; AND</p> <p>The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND</p> <p>The treatment must not be in combination with acalabrutinib.</p>","N","N","N","IMMEDIATE","ALL","N","2026-06-01","N","4708"
"18722_18898_R","First continuing treatment (Face, hand, foot)","AUTHORITY_REQUIRED","18898","18722","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment (Face, hand, foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""left"">The assessment of response to treatment must be provided in this application and documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment (Face, hand, foot)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""left"">The assessment of response to treatment must be provided in this application and documented in the patient&apos;s medical records.</p>","N","N","N","FULL","ALL","N","2026-07-01","Y","4708"
"18724_18829_R","Continuing treatment","AUTHORITY_REQUIRED","18829","18724","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be used in combination with trastuzumab; AND</p> <p>The treatment must have been initiated in combination with chemotherapy; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>The treatment must not extend beyond the following when initial and continuing therapy are combined: (i) 18 weeks (6 cycles) in the neoadjuvant setting; or (ii) 12 months (18 cycles) in total.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be used in combination with trastuzumab; AND</p> <p>The treatment must have been initiated in combination with chemotherapy; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>The treatment must not extend beyond the following when initial and continuing therapy are combined: (i) 18 weeks (6 cycles) in the neoadjuvant setting; or (ii) 12 months (18 cycles) in total.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18725_18725_R","Initial treatment","AUTHORITY_REQUIRED","18725","18725","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>Patient must not have previously received PBS-subsidised treatment with alectinib as adjuvant therapy in resected non-small cell lung cancer; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Must be treated by a medical practitioner.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial treatment</p><br/><p>Patient must not have previously received PBS-subsidised treatment with alectinib as adjuvant therapy in resected non-small cell lung cancer; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Must be treated by a medical practitioner.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18726_18726_R","Continuing treatment","AUTHORITY_REQUIRED","18726","18726","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this indication (i.e. for stage IIIB/IV NSCLC); AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this indication (i.e. for stage IIIB/IV NSCLC); AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18727_18792_R","Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)","AUTHORITY_REQUIRED","18792","18727","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; or</p> <p>Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have blood eosinophil count of at least 300 cells per microlitre in the 12 months prior to initiating treatment with this drug; or</p> <p>Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the 12 months prior to initiating treatment with this drug; or</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the 12 months prior to initiating treatment with this drug that has past or current evidence of atopy, documented by either: (i) skin prick testing; or (ii) an in vitro measure of specific IgE; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the month prior to initiating this drug, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the 12 months prior to initiating this drug, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of tezepelumab sufficient for up to 32 weeks of therapy, at a dose of 210 mg every four weeks.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and</p><p align=""justify"">(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(e) if applicable, the eosinophil count and date; and</p><p align=""justify"">(f) if applicable, the IgE result and date.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; or</p> <p>Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have blood eosinophil count of at least 300 cells per microlitre in the 12 months prior to initiating treatment with this drug; or</p> <p>Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the 12 months prior to initiating treatment with this drug; or</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the 12 months prior to initiating treatment with this drug that has past or current evidence of atopy, documented by either: (i) skin prick testing; or (ii) an in vitro measure of specific IgE; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the month prior to initiating this drug, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the 12 months prior to initiating this drug, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of tezepelumab sufficient for up to 32 weeks of therapy, at a dose of 210 mg every four weeks.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and</p><p align=""justify"">(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(e) if applicable, the eosinophil count and date; and</p><p align=""justify"">(f) if applicable, the IgE result and date.</p>","N","N","N","FULL","ALL","N","2026-07-01","Y","4708"
"18728_18731_R","Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)","AUTHORITY_REQUIRED","18731","18728","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; or</p> <p>Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have past or current evidence of atopy that is no more than 1 year old at the time of application that is documented by either: (i) skin prick testing, (ii) an in vitro measure of specific IgE; AND</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to the time of application; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for severe asthma within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines for severe asthma within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details of prior optimised asthma drug therapy (dosage, date of commencement, duration of therapy); and</p><p align=""justify"">(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) the IgE result and date; and</p><p align=""justify"">(e) Asthma Control Questionnaire (ACQ-5) score.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; or</p> <p>Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have past or current evidence of atopy that is no more than 1 year old at the time of application that is documented by either: (i) skin prick testing, (ii) an in vitro measure of specific IgE; AND</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to the time of application; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for severe asthma within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines for severe asthma within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details of prior optimised asthma drug therapy (dosage, date of commencement, duration of therapy); and</p><p align=""justify"">(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) the IgE result and date; and</p><p align=""justify"">(e) Asthma Control Questionnaire (ACQ-5) score.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the accepted toxicities, including severity, which will be accepted for the purposes of exempting a patient from the requirement of treatment with optimised asthma therapy.</p> <p align=""justify"">Formal assessment and correction of inhaler technique should be performed in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique (available at www.nationalasthma.org.au); the assessment and adherence to correct technique should be documented in the patient&apos;s medical records. Patients can obtain support with inhaler technique through their local Asthma Foundation (1800 645 130).</p>","N","N","N","FULL","ALL","N","2026-07-01","Y","4708"
"18730_18874_R","Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)","AUTHORITY_REQUIRED","18874","18730","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; or</p> <p>Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; or</p> <p>Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course of benralizumab sufficient for up to 32 weeks of therapy, at a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and</p><p align=""justify"">(b) if applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) the eosinophil count and date; and</p><p align=""justify"">(e) Asthma Control Questionnaire (ACQ-5) score.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; or</p> <p>Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; or</p> <p>Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course of benralizumab sufficient for up to 32 weeks of therapy, at a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and</p><p align=""justify"">(b) if applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) the eosinophil count and date; and</p><p align=""justify"">(e) Asthma Control Questionnaire (ACQ-5) score.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the accepted toxicities, including severity, which will be accepted for the purposes of exempting a patient from the requirement of treatment with optimised asthma therapy.</p> <p align=""justify"">Formal assessment and correction of inhaler technique should be performed in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique (available at www.nationalasthma.org.au); the assessment and adherence to correct technique should be documented in the patient&apos;s medical records. Patients can obtain support with inhaler technique through their local Asthma Foundation (1800 645 130).</p>","N","N","N","FULL","ALL","N","2026-07-01","Y","4708"
"18733_18798_R","Initial sole PBS-subsidised supply for anticipated emergency treatment","AUTHORITY_REQUIRED","18798","18733","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute allergic reaction with anaphylaxis</p><br/><p>Initial sole PBS-subsidised supply for anticipated emergency treatment</p><br/><p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a clinical immunologist; or</p> <p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with an allergist; or</p> <p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a paediatrician; or</p> <p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a respiratory physician; AND</p> <p>Patient must be aged 4 years or older; AND</p> <p>Patient must weigh 15 kg or more.</p> <p align=""justify"">The name of the specialist consulted must be provided at the time of application for initial supply.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute allergic reaction with anaphylaxis</p><br/><p>Initial sole PBS-subsidised supply for anticipated emergency treatment</p><br/><p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a clinical immunologist; or</p> <p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with an allergist; or</p> <p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a paediatrician; or</p> <p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a respiratory physician; AND</p> <p>Patient must be aged 4 years or older; AND</p> <p>Patient must weigh 15 kg or more.</p> <p align=""justify"">The name of the specialist consulted must be provided at the time of application for initial supply.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18735_18832_R","Continuing treatment","AUTHORITY_REQUIRED","18832","18735","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or chemotherapy refractory Peripheral T-cell Lymphoma</p><br/><p>Continuing treatment</p><br/><p>The condition must be relapsed or chemotherapy refractory; AND</p> <p>Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or chemotherapy refractory Peripheral T-cell Lymphoma</p><br/><p>Continuing treatment</p><br/><p>The condition must be relapsed or chemotherapy refractory; AND</p> <p>Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18739_18738_R","Initial treatment 1 - New patient","AUTHORITY_REQUIRED","18738","18739","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 1 - New patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information and no repeats.</p> <p align=""justify"">Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.</p> <p align=""justify"">If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA-approved Product Information.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 1 - New patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information and no repeats.</p> <p align=""justify"">Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.</p> <p align=""justify"">If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA-approved Product Information.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-07-01","Y","4708"
"18740_18859_R","Initial 2 - starting combination therapy that has a prostanoid in the combination (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of PAH is established through a prior PBS authority application","AUTHORITY_REQUIRED","18859","18740","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 2 - starting combination therapy that has a prostanoid in the combination (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of PAH is established through a prior PBS authority application</p><br/><p>Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND</p> <p>Patient must have failed to achieve/maintain WHO functional class II status with at least one of the following: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy, (iv) dual combination therapy with an endothelin receptor antagonist plus a phosphodiesterase-5 inhibitor; AND</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 2 - starting combination therapy that has a prostanoid in the combination (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of PAH is established through a prior PBS authority application</p><br/><p>Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND</p> <p>Patient must have failed to achieve/maintain WHO functional class II status with at least one of the following: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy, (iv) dual combination therapy with an endothelin receptor antagonist plus a phosphodiesterase-5 inhibitor; AND</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">Where a patient has had at least one PAH agent PBS-subsidised and the other(s) non-PBS-subsidised, apply under this &apos;Initial 2&apos; treatment phase for the non-PBS-subsidised agent(s). Transitioning of the non-PBS to PBS-subsidised supply will be subject to restrictions in Initial 2. For the existing PBS-subsidised agent(s), the authority application(s) are to be through the Continuing treatment phase of that agent(s).</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18742_18737_R","Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application","AUTHORITY_REQUIRED","18737","18742","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; prior monotherapy has been inadequate - the patient has at least WHO functional class III PAH; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate - the patient has WHO functional class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; prior monotherapy has been inadequate - the patient has at least WHO functional class III PAH; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate - the patient has WHO functional class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">Where a patient has had at least one PAH agent PBS-subsidised and the other(s) non-PBS-subsidised, apply under this &apos;Initial 2&apos; treatment phase for the non-PBS-subsidised agent(s). Transitioning of the non-PBS to PBS-subsidised supply will be subject to restrictions in Initial 2. For the existing PBS-subsidised agent(s), the authority application(s) are to be through the Continuing treatment phase of that agent(s).</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18744_18782_R","Initial treatment 1 - New patient","AUTHORITY_REQUIRED","18782","18744","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 1 - New patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 1 - New patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-07-01","Y","4708"
"18745_18748_R","Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient","AUTHORITY_REQUIRED","18748","18745","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; this combination therapy is treating a patient with at least class WHO functional class III PAH; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; this combination therapy is treating a patient with at least class WHO functional class III PAH; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-07-01","Y","4708"
"18746_18854_R","Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application","AUTHORITY_REQUIRED","18854","18746","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; prior monotherapy has been inadequate - the patient has at least WHO functional class III PAH; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate - the patient has WHO functional class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; prior monotherapy has been inadequate - the patient has at least WHO functional class III PAH; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate - the patient has WHO functional class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">Where a patient has had at least one PAH agent PBS-subsidised and the other(s) non-PBS-subsidised, apply under this &apos;Initial 2&apos; treatment phase for the non-PBS-subsidised agent(s). Transitioning of the non-PBS to PBS-subsidised supply will be subject to restrictions in Initial 2. For the existing PBS-subsidised agent(s), the authority application(s) are to be through the Continuing treatment phase of that agent(s).</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18747_18749_R","Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)","AUTHORITY_REQUIRED","18749","18747","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; or</p> <p>Patient must be undergoing continuing treatment with dual combination therapy consisting of endothelin receptor antagonist with phosphodiesterase-5 inhibitor where one drug was prescribed as a non-PBS benefit; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; or</p> <p>Patient must be undergoing continuing treatment with dual combination therapy consisting of endothelin receptor antagonist with phosphodiesterase-5 inhibitor where one drug was prescribed as a non-PBS benefit; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">If this authority application is to continue combination therapy, but with a change in at least one agent, the &apos;Initial 3 - change&apos; treatment phase restriction of the new drug(s) outlines the continuing eligibility of that new drug.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18750_18836_R","Initial treatment 1 - New patient","AUTHORITY_REQUIRED","18836","18750","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 1 - New patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 1 - New patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-07-01","Y","4708"
"18751_18743_R","Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)","AUTHORITY_REQUIRED","18743","18751","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; or</p> <p>Patient must be undergoing continuing treatment with dual combination therapy consisting of endothelin receptor antagonist with phosphodiesterase-5 inhibitor where one drug was prescribed as a non-PBS benefit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; or</p> <p>Patient must be undergoing continuing treatment with dual combination therapy consisting of endothelin receptor antagonist with phosphodiesterase-5 inhibitor where one drug was prescribed as a non-PBS benefit.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">If this authority application is to continue combination therapy, but with a change in at least one agent, the &apos;Initial 3 - change&apos; treatment phase restriction of the new drug(s) outlines the continuing eligibility of that new drug.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18753_6181_R","null","STREAMLINED","6181","18753","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylous ascites</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylous ascites</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18754_6135_R","null","STREAMLINED","6135","18754","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cerebrospinal fluid glucose transporter defect</p><br/><p>Patient must require a ketogenic diet.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cerebrospinal fluid glucose transporter defect</p><br/><p>Patient must require a ketogenic diet.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18755_6203_R","null","STREAMLINED","6203","18755","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperlipoproteinaemia type 1</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperlipoproteinaemia type 1</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18756_4652_R","null","RESTRICTED","4652","18756","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylous ascites</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylous ascites</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18757_4659_R","null","RESTRICTED","4659","18757","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Long chain fatty acid oxidation disorders</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Long chain fatty acid oxidation disorders</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18758_18878_R","Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)","AUTHORITY_REQUIRED","18878","18758","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of flared disease must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of flared disease must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18761_18896_R","Extended induction period (optional) from weeks 12 to 24","AUTHORITY_REQUIRED","18896","18761","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Extended induction period (optional) from weeks 12 to 24</p><br/><p>Patient must must have experienced an inadequate therapeutic benefit following the initial 12-week induction period; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Extended induction period (optional) from weeks 12 to 24</p><br/><p>Patient must must have experienced an inadequate therapeutic benefit following the initial 12-week induction period; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18762_18811_R","Continuing (maintenance) treatment","AUTHORITY_REQUIRED","18811","18762","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing (maintenance) treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing (maintenance) treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18763_18845_R","Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)","AUTHORITY_REQUIRED","18845","18763","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment; and</p><p align=""left"">(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline CDAI score and the date of assessment; and/or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.</p> <p align=""left"">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 12 weeks of treatment with upadacitinib may be requested under the Balance of supply restriction.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment; and</p><p align=""left"">(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline CDAI score and the date of assessment; and/or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.</p> <p align=""left"">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 12 weeks of treatment with upadacitinib may be requested under the Balance of supply restriction.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18764_18867_R","Balance of supply","AUTHORITY_REQUIRED","18867","18764","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial or extended induction restriction (Initial 1, Initial 2, Initial 3, or Extended induction period (optional) treatment); AND</p> <p>The treatment must provide no more than the balance of up to 12 weeks therapy available under Initial 1, 2 or 3 treatment restriction or the Extended induction period (optional) from weeks 12 to 24 treatment restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial or extended induction restriction (Initial 1, Initial 2, Initial 3, or Extended induction period (optional) treatment); AND</p> <p>The treatment must provide no more than the balance of up to 12 weeks therapy available under Initial 1, 2 or 3 treatment restriction or the Extended induction period (optional) from weeks 12 to 24 treatment restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18766_18767_R","Balance of supply","AUTHORITY_REQUIRED","18767","18766","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial or continuing restriction (Initial 1, Initial 2, Initial 3, or Continuing treatment); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial or continuing restriction (Initial 1, Initial 2, Initial 3, or Continuing treatment); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18768_18771_R","Continuing treatment","AUTHORITY_REQUIRED","18771","18768","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18769_18813_R","Initial 1 (new patient)","AUTHORITY_REQUIRED","18813","18769","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; or</p> <p>Patient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(c) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(d) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(e) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of not achieving an adequate response to prior therapy must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""justify"">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; or</p> <p>Patient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(c) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(d) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(e) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of not achieving an adequate response to prior therapy must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""justify"">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18770_18815_R","Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)","AUTHORITY_REQUIRED","18815","18770","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of flared disease must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""justify"">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of flared disease must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""justify"">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18772_18814_R","Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)","AUTHORITY_REQUIRED","18814","18772","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment; and</p><p align=""left"">(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline CDAI score and the date of assessment; and/or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.</p> <p align=""justify"">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment; and</p><p align=""left"">(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline CDAI score and the date of assessment; and/or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.</p> <p align=""justify"">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18773_18866_R","Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)","AUTHORITY_REQUIRED","18866","18773","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; AND</p> <p>The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment; and</p><p align=""left"">(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline CDAI score and the date of assessment; and/or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; AND</p> <p>The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment; and</p><p align=""left"">(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline CDAI score and the date of assessment; and/or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18775_C","null","null","null","null","null","<p align=""justify"">Severe cholestatic jaundice has been reported with this drug. Significant risk factors are age, particularly greater than 55 years, and duration of treatment longer than 14 days.</p>","N","Y","N","null","null","N","2016-06-01","N","4708"
"18778_18870_R","null","STREAMLINED","18870","18778","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe primary axillary hyperhidrosis</p><br/><p>Patient must have previously failed topical aluminium chloride after one to two months of treatment; or</p> <p>Patient must be intolerant to topical aluminium chloride treatment; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe primary axillary hyperhidrosis</p><br/><p>Patient must have previously failed topical aluminium chloride after one to two months of treatment; or</p> <p>Patient must be intolerant to topical aluminium chloride treatment; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18779_18871_R","Induction treatment of relapsed or refractory B-precursor cell ALL","AUTHORITY_REQUIRED","18871","18779","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Induction treatment of relapsed or refractory B-precursor cell ALL</p><br/><p>The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND</p> <p>The condition must not be present in the central nervous system or testis; AND</p> <p>Patient must not have received more than 1 line of salvage therapy; AND</p> <p>The condition must be one of the following: (i) untreated with this drug for Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL), (ii) treated with this drug for Pre-B-cell ALL, but the condition has not relapsed within 6 months of completing that course of treatment; AND</p> <p>The condition must have more than 5% blasts in bone marrow; or</p> <p>The condition must have measurable residual disease based on measurement in bone marrow following complete remission; AND</p> <p>The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.</p> <p align=""justify"">An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment - balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.</p> <p align=""justify"">Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Acute Lymphoblastic Leukaemia in complete haematological remission PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">(3) date of most recent chemotherapy (if applicable), and if this was the initial chemotherapy regimen or salvage therapy;</p><p align=""justify"">(4) for Philadelphia chromosome positive patients:</p><p align=""justify"">(i) the date of the most recent treatment with a TKI (in combination with chemotherapy); OR</p><p align=""justify"">(ii) if applicable the date of initial combined treatment with TKI and corticosteroids (if unable to tolerate chemotherapy).</p><p align=""justify"">(5) if applicable, the date of completion of blinatumomab treatment for Pre-B-cell ALL in CR and the date of the patient&apos;s subsequent relapse; and</p><p align=""justify"">(6) the percentage blasts in bone marrow count measured that is no more than 4 weeks old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute lymphoblastic leukaemia</p><br/><p>Induction treatment of relapsed or refractory B-precursor cell ALL</p><br/><p>The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND</p> <p>The condition must not be present in the central nervous system or testis; AND</p> <p>Patient must not have received more than 1 line of salvage therapy; AND</p> <p>The condition must be one of the following: (i) untreated with this drug for Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL), (ii) treated with this drug for Pre-B-cell ALL, but the condition has not relapsed within 6 months of completing that course of treatment; AND</p> <p>The condition must have more than 5% blasts in bone marrow; or</p> <p>The condition must have measurable residual disease based on measurement in bone marrow following complete remission; AND</p> <p>The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.</p> <p align=""justify"">According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.</p> <p align=""justify"">An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment - balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.</p> <p align=""justify"">Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed Acute Lymphoblastic Leukaemia in complete haematological remission PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">(3) date of most recent chemotherapy (if applicable), and if this was the initial chemotherapy regimen or salvage therapy;</p><p align=""justify"">(4) for Philadelphia chromosome positive patients:</p><p align=""justify"">(i) the date of the most recent treatment with a TKI (in combination with chemotherapy); OR</p><p align=""justify"">(ii) if applicable the date of initial combined treatment with TKI and corticosteroids (if unable to tolerate chemotherapy).</p><p align=""justify"">(5) if applicable, the date of completion of blinatumomab treatment for Pre-B-cell ALL in CR and the date of the patient&apos;s subsequent relapse; and</p><p align=""justify"">(6) the percentage blasts in bone marrow count measured that is no more than 4 weeks old at the time of application.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","Y","4708"
"18781_18824_R","Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient","AUTHORITY_REQUIRED","18824","18781","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; this combination therapy is treating a patient with at least class WHO functional class III PAH; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; this combination therapy is treating a patient with at least class WHO functional class III PAH; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-07-01","Y","4708"
"18783_18825_R","Initial 1 (new patient)","AUTHORITY_REQUIRED","18825","18783","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; or</p> <p>Patient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; AND</p> <p>The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(c) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(d) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(e) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of not achieving an adequate response to prior therapy must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient&apos;s weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; or</p> <p>Patient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; AND</p> <p>The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(c) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(d) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(e) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of not achieving an adequate response to prior therapy must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient&apos;s weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18784_18856_R","Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)","AUTHORITY_REQUIRED","18856","18784","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; AND</p> <p>The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment; and</p><p align=""left"">(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline CDAI score and the date of assessment; and/or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.</p> <p align=""left"">Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient&apos;s weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; AND</p> <p>The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment; and</p><p align=""left"">(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline CDAI score and the date of assessment; and/or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.</p> <p align=""left"">Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient&apos;s weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18786_18721_R","Continuing treatment","STREAMLINED","18721","18786","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18787_18785_R","Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)","AUTHORITY_REQUIRED","18785","18787","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy; AND</p> <p>The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of flared disease must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient&apos;s weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy; AND</p> <p>The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of flared disease must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient&apos;s weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18788_18899_R","Initial treatment","AUTHORITY_REQUIRED","18899","18788","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH); AND</p> <p>Patient must have locally advanced, inflammatory or early stage, high risk (tumour greater than 2 cm in diameter or lymph node positive) breast cancer; AND</p> <p>The treatment must be used in combination with trastuzumab; AND</p> <p>The treatment must be initiated in combination with chemotherapy; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 1 treatment cycle under this restriction; AND</p> <p>The treatment must not extend beyond the following when initial and continuing therapy are combined: (i) 18 weeks (6 cycles) in the neoadjuvant setting; or (ii) 12 months (18 cycles) in total.</p> <p align=""justify"">Details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification by in situ hybridisation (ISH) must be provided at the time of application.</p><p align=""justify"">The pathology report must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Early HER2 positive breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH); AND</p> <p>Patient must have locally advanced, inflammatory or early stage, high risk (tumour greater than 2 cm in diameter or lymph node positive) breast cancer; AND</p> <p>The treatment must be used in combination with trastuzumab; AND</p> <p>The treatment must be initiated in combination with chemotherapy; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND</p> <p>Patient must not receive more than 1 treatment cycle under this restriction; AND</p> <p>The treatment must not extend beyond the following when initial and continuing therapy are combined: (i) 18 weeks (6 cycles) in the neoadjuvant setting; or (ii) 12 months (18 cycles) in total.</p> <p align=""justify"">Details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification by in situ hybridisation (ISH) must be provided at the time of application.</p><p align=""justify"">The pathology report must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18790_18858_R","Initial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)","AUTHORITY_REQUIRED","18858","18790","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; or</p> <p>Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have been receiving regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; AND</p> <p>Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; or</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the last 12 months that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes:</p><p align=""justify"">(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;</p><p align=""justify"">AND</p><p align=""justify"">(ii) treatment with oral corticosteroids as outlined in the clinical criteria.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter.</p><p align=""justify"">A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and</p><p align=""justify"">(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(e) if applicable, the eosinophil count and date; and</p><p align=""justify"">(f) if applicable, the IgE result and date.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; or</p> <p>Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have been receiving regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; AND</p> <p>Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; or</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the last 12 months that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes:</p><p align=""justify"">(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;</p><p align=""justify"">AND</p><p align=""justify"">(ii) treatment with oral corticosteroids as outlined in the clinical criteria.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter.</p><p align=""justify"">A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and</p><p align=""justify"">(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(e) if applicable, the eosinophil count and date; and</p><p align=""justify"">(f) if applicable, the IgE result and date.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the accepted toxicities, including severity, which will be accepted for the purposes of exempting a patient from the requirement of treatment with optimised asthma therapy.</p> <p align=""justify"">Formal assessment and correction of inhaler technique should be performed in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique (available at www.nationalasthma.org.au); the assessment and adherence to correct technique should be documented in the patient&apos;s medical records. Patients can obtain support with inhaler technique through their local Asthma Foundation (1800 645 130).</p>","N","N","N","FULL","ALL","N","2026-07-01","Y","4708"
"18791_18830_R","Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)","AUTHORITY_REQUIRED","18830","18791","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; or</p> <p>Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; or</p> <p>Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of mepolizumab sufficient for up to 32 weeks of therapy.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and</p><p align=""justify"">(b) if applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) the eosinophil count and date; and</p><p align=""justify"">(e) Asthma Control Questionnaire (ACQ-5) score.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; or</p> <p>Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; or</p> <p>Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of mepolizumab sufficient for up to 32 weeks of therapy.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and</p><p align=""justify"">(b) if applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) the eosinophil count and date; and</p><p align=""justify"">(e) Asthma Control Questionnaire (ACQ-5) score.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the accepted toxicities, including severity, which will be accepted for the purposes of exempting a patient from the requirement of treatment with optimised asthma therapy.</p> <p align=""justify"">Formal assessment and correction of inhaler technique should be performed in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique (available at www.nationalasthma.org.au); the assessment and adherence to correct technique should be documented in the patient&apos;s medical records. Patients can obtain support with inhaler technique through their local Asthma Foundation (1800 645 130).</p>","N","N","N","FULL","ALL","N","2026-07-01","Y","4708"
"18794_18729_R","Continuing treatment","AUTHORITY_REQUIRED","18729","18794","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,</p><p align=""justify"">OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.</p> <p align=""justify"">All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.</p><p align=""justify"">The assessment should, where possible, be completed by the same physician who initiated treatment with this drug and should be conducted within 4 weeks of the last dose of biological medicine.</p><p align=""justify"">Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient&apos;s response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.</p><p align=""justify"">A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) if applicable, details of maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) a completed Asthma Control Questionnaire (ACQ-5) score.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An adequate response to this biological medicine is defined as:</p><p align=""justify"">(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,</p><p align=""justify"">OR</p><p align=""justify"">(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.</p> <p align=""justify"">All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.</p><p align=""justify"">The assessment should, where possible, be completed by the same physician who initiated treatment with this drug and should be conducted within 4 weeks of the last dose of biological medicine.</p><p align=""justify"">Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient&apos;s response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.</p><p align=""justify"">A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following information must be provided at the time of application and must be documented in the patient&apos;s medical records:</p><p align=""justify"">(a) if applicable, details of maintenance oral corticosteroid dose; and</p><p align=""justify"">(b) a completed Asthma Control Questionnaire (ACQ-5) score.</p>","N","N","N","FULL","ALL","N","2026-07-01","Y","4708"
"18797_18795_R","Initial sole PBS-subsidised supply for anticipated emergency treatment","AUTHORITY_REQUIRED","18795","18797","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute allergic reaction with anaphylaxis</p><br/><p>Initial sole PBS-subsidised supply for anticipated emergency treatment</p><br/><p>Patient must have been discharged from hospital or an emergency department after treatment with adrenaline (epinephrine) for acute allergic reaction with anaphylaxis; AND</p> <p>Patient must be aged 4 years or older; AND</p> <p>Patient must weigh 15 kg or more.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute allergic reaction with anaphylaxis</p><br/><p>Initial sole PBS-subsidised supply for anticipated emergency treatment</p><br/><p>Patient must have been discharged from hospital or an emergency department after treatment with adrenaline (epinephrine) for acute allergic reaction with anaphylaxis; AND</p> <p>Patient must be aged 4 years or older; AND</p> <p>Patient must weigh 15 kg or more.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18799_18800_R","Initial treatment","AUTHORITY_REQUIRED","18800","18799","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or chemotherapy refractory Peripheral T-cell Lymphoma</p><br/><p>Initial treatment</p><br/><p>The condition must be relapsed or chemotherapy refractory; AND</p> <p>Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or chemotherapy refractory Peripheral T-cell Lymphoma</p><br/><p>Initial treatment</p><br/><p>The condition must be relapsed or chemotherapy refractory; AND</p> <p>Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18801_18752_R","Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient","AUTHORITY_REQUIRED","18752","18801","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; this combination therapy is treating a patient with at least WHO functional class III PAH; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; this combination therapy is treating a patient with at least WHO functional class III PAH; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-07-01","Y","4708"
"18803_6164_R","null","STREAMLINED","6164","18803","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fat malabsorption</p><br/><p>The condition must be due to liver disease; or</p> <p>The condition must be due to short gut syndrome; or</p> <p>The condition must be due to cystic fibrosis; or</p> <p>The condition must be due to gastrointestinal disorders.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fat malabsorption</p><br/><p>The condition must be due to liver disease; or</p> <p>The condition must be due to short gut syndrome; or</p> <p>The condition must be due to cystic fibrosis; or</p> <p>The condition must be due to gastrointestinal disorders.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18804_4653_R","null","RESTRICTED","4653","18804","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylothorax</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylothorax</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18808_18810_R","Continuing (maintenance) treatment","AUTHORITY_REQUIRED","18810","18808","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing (maintenance) treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; or</p> <p>The condition must have not met the improvements specified above due to the prescribed dose being too low - this authority application seeks higher dosing; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing (maintenance) treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; or</p> <p>The condition must have not met the improvements specified above due to the prescribed dose being too low - this authority application seeks higher dosing; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18812_18765_R","Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)","AUTHORITY_REQUIRED","18765","18812","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of flared disease must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 12 weeks of treatment with upadacitinib may be requested under the Balance of supply restriction.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of flared disease must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 12 weeks of treatment with upadacitinib may be requested under the Balance of supply restriction.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18816_18775_R","Continuing treatment","AUTHORITY_REQUIRED","18775","18816","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""left"">A maximum quantity and number of repeats to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered every 8 weeks will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the continuing treatment period.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""left"">A maximum quantity and number of repeats to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered every 8 weeks will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the continuing treatment period.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18818_18819_R","Continuing treatment","STREAMLINED","18819","18818","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">A maximum quantity to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose will be authorised.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">A maximum quantity to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose will be authorised.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18821_18777_R","Balance of supply","AUTHORITY_REQUIRED","18777","18821","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive); AND</p> <p>The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive); AND</p> <p>The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18823_18852_R","Initial treatment 1 - New patient","AUTHORITY_REQUIRED","18852","18823","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 1 - New patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 1 - New patient</p><br/><p>Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(a) details of the proposed prescription; and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:</p><p align=""justify"">(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or</p><p align=""justify"">(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.</p><p align=""justify"">(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:</p><p align=""justify"">- RHC composite assessment; and</p><p align=""justify"">- ECHO composite assessment; and</p><p align=""justify"">- 6 Minute Walk Test (6MWT)</p><p align=""justify"">Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- RHC plus ECHO composite assessments;</p><p align=""justify"">- RHC composite assessment plus 6MWT;</p><p align=""justify"">- RHC composite assessment only.</p><p align=""justify"">In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:</p><p align=""justify"">- ECHO composite assessment plus 6MWT;</p><p align=""justify"">- ECHO composite assessment only.</p><p align=""justify"">(3) Document the findings of these tests in the patient&apos;s medical records, including, where relevant only, the reason/s:</p><p align=""justify"">(i) for why fewer than 3 tests are able to be performed on clinical grounds;</p><p align=""justify"">(ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient&apos;s medical records.</p><p align=""justify"">(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.</p><p align=""justify"">(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">The test results must not be more than 6 months old at the time of application.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p> <p align=""justify"">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-07-01","Y","4708"
"18828_18828_R","null","STREAMLINED","18828","18828","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic cholangiocarcinoma</p><br/><p>Patient must have evidence of a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement at treatment initiation; AND</p> <p>Patient must have/have had received at least one line of systemic therapy prior to treatment initiation; AND</p> <p>Patient must have/have had a World Health Organisation (WHO) performance status of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic cholangiocarcinoma</p><br/><p>Patient must have evidence of a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement at treatment initiation; AND</p> <p>Patient must have/have had received at least one line of systemic therapy prior to treatment initiation; AND</p> <p>Patient must have/have had a World Health Organisation (WHO) performance status of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18831_18732_R","Initial treatment - Initial 2 (Change of treatment)","AUTHORITY_REQUIRED","18732","18831","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND</p> <p>Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing biological medicine treatment for severe asthma; or</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing biological medicine treatment for severe asthma; or</p> <p>Patient must have each of: i) total serum human immunoglobulin E of at least 30 IU/mL measured no more than 12 months prior to initiating treatment with a biological medicine for severe asthma, ii) past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating treatment with a biological medicine for severe asthma; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of tezepelumab sufficient for up to 32 weeks of therapy, at a dose of 210 mg every four weeks.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and</p><p align=""justify"">(b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and</p><p align=""justify"">(c) if applicable, the eosinophil count and date; and</p><p align=""justify"">(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and</p><p align=""justify"">(e) if applicable, the IgE result and date; and</p><p align=""justify"">(f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment - Initial 2 (Change of treatment)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND</p> <p>Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing biological medicine treatment for severe asthma; or</p> <p>Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing biological medicine treatment for severe asthma; or</p> <p>Patient must have each of: i) total serum human immunoglobulin E of at least 30 IU/mL measured no more than 12 months prior to initiating treatment with a biological medicine for severe asthma, ii) past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating treatment with a biological medicine for severe asthma; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient&apos;s most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.</p><p align=""justify"">An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of tezepelumab sufficient for up to 32 weeks of therapy, at a dose of 210 mg every four weeks.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and</p><p align=""justify"">(b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and</p><p align=""justify"">(c) if applicable, the eosinophil count and date; and</p><p align=""justify"">(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and</p><p align=""justify"">(e) if applicable, the IgE result and date; and</p><p align=""justify"">(f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).</p>","N","N","N","FULL","ALL","N","2026-07-01","Y","4708"
"18834_18833_R","Initial treatment 2 - Change of treatment","AUTHORITY_REQUIRED","18833","18834","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 2 - Change of treatment</p><br/><p>Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Swapping between PAH agents: <br/>Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent&apos;s restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.</p><p align=""justify"">Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.</p> <p align=""justify"">If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information and no repeats.</p> <p align=""justify"">Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.</p> <p align=""justify"">If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA-approved Product Information.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 2 - Change of treatment</p><br/><p>Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Swapping between PAH agents: <br/>Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent&apos;s restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.</p><p align=""justify"">Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.</p> <p align=""justify"">If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information and no repeats.</p> <p align=""justify"">Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.</p> <p align=""justify"">If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA-approved Product Information.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18835_18802_R","Initial 3 - changing the prostanoid agent in combination therapy (dual or triple therapy)","AUTHORITY_REQUIRED","18802","18835","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 3 - changing the prostanoid agent in combination therapy (dual or triple therapy)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 3 - changing the prostanoid agent in combination therapy (dual or triple therapy)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18837_6155_R","null","STREAMLINED","6155","18837","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable childhood epilepsy</p><br/><p>Patient must require a ketogenic diet.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Intractable childhood epilepsy</p><br/><p>Patient must require a ketogenic diet.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18838_6146_R","null","STREAMLINED","6146","18838","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Long chain fatty acid oxidation disorders</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Long chain fatty acid oxidation disorders</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18839_18840_R","Initial treatment","AUTHORITY_REQUIRED","18840","18839","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Generalized convulsive status epilepticus</p><br/><p>Initial treatment</p><br/><p>Patient must have been assessed to be at significant risk of status epilepticus; AND</p> <p>Patient must have experienced at least one prolonged seizure (greater than 5 minutes duration) requiring emergency medical attention within the previous 5 years; AND</p> <p>Patient must be at least six months of age; AND</p> <p>The treatment must be initiated by a specialist physician experienced in the treatment of epilepsy.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity to cater for the patient&apos;s circumstances.</p><p align=""justify"">Up to a maximum of 10 syringes for each prescription can be authorised for patients with high frequency seizures.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Generalized convulsive status epilepticus</p><br/><p>Initial treatment</p><br/><p>Patient must have been assessed to be at significant risk of status epilepticus; AND</p> <p>Patient must have experienced at least one prolonged seizure (greater than 5 minutes duration) requiring emergency medical attention within the previous 5 years; AND</p> <p>Patient must be at least six months of age; AND</p> <p>The treatment must be initiated by a specialist physician experienced in the treatment of epilepsy.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of the authority application, medical practitioners should request the appropriate quantity to cater for the patient&apos;s circumstances.</p><p align=""justify"">Up to a maximum of 10 syringes for each prescription can be authorised for patients with high frequency seizures.</p>","N","N","N","IMMEDIATE","ALL","Y","2026-07-01","N","4708"
"18841_18877_R","Balance of supply","AUTHORITY_REQUIRED","18877","18841","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial or continuing restriction (Initial 1, Initial 2, Initial 3, Continuing, or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment) with the subcutaneous form; AND</p> <p>The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under either Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial or continuing restriction (Initial 1, Initial 2, Initial 3, Continuing, or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment) with the subcutaneous form; AND</p> <p>The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under either Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18842_18909_R","Initial 1 (new patient)","AUTHORITY_REQUIRED","18909","18842","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; or</p> <p>Patient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(c) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(d) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(e) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of not achieving an adequate response to prior therapy must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; or</p> <p>Patient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(c) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(d) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(e) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of not achieving an adequate response to prior therapy must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18843_18879_R","Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient","AUTHORITY_REQUIRED","18879","18843","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient</p><br/><p>Patient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program); AND</p> <p>Patient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition; AND</p> <p>Patient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">If fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend beyond 24 weeks.</p> <p align=""left"">A patient may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient</p><br/><p>Patient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program); AND</p> <p>Patient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition; AND</p> <p>Patient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">If fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend beyond 24 weeks.</p> <p align=""left"">A patient may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18844_18760_R","Initial 4 (additional dose at week 10)","AUTHORITY_REQUIRED","18760","18844","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 4 (additional dose at week 10)</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition in this treatment cycle; AND</p> <p>Patient must have received 3 doses of initial treatment under either: (i) Initial 1, (ii) Initial 2, (iii) Initial 3; AND</p> <p>Patient must not have achieved an adequate response to this drug after a total of 3 doses of initial treatment under either: (i) Initial 1, (ii) Initial 2, (iii) Initial 3; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an additional dose of this drug consisting of one vial of 300 mg, with one dose to be administered at week 10, will be authorised.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">Patient must be assessed as having an inadequate response to the drug after completing an initial infusion regimen at 0, 2, and 6 weeks and prior to 10 weeks.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 4 (additional dose at week 10)</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition in this treatment cycle; AND</p> <p>Patient must have received 3 doses of initial treatment under either: (i) Initial 1, (ii) Initial 2, (iii) Initial 3; AND</p> <p>Patient must not have achieved an adequate response to this drug after a total of 3 doses of initial treatment under either: (i) Initial 1, (ii) Initial 2, (iii) Initial 3; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an additional dose of this drug consisting of one vial of 300 mg, with one dose to be administered at week 10, will be authorised.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">Patient must be assessed as having an inadequate response to the drug after completing an initial infusion regimen at 0, 2, and 6 weeks and prior to 10 weeks.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18846_18774_R","Initial 1 (new patient)","AUTHORITY_REQUIRED","18774","18846","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; or</p> <p>Patient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; AND</p> <p>The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(c) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(d) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(e) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of not achieving an adequate response to prior therapy must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; or</p> <p>Patient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; AND</p> <p>The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(c) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(d) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(e) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of not achieving an adequate response to prior therapy must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18847_18776_R","Balance of supply","AUTHORITY_REQUIRED","18776","18847","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under the Initial 1, 2 or 3 restrictions to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient treatment with this drug for this condition under the Continuing restriction to complete 24 weeks of treatment (8-weekly infusion regimen); AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under the Initial 1, 2 or 3 restrictions to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient treatment with this drug for this condition under the Continuing restriction to complete 24 weeks of treatment (8-weekly infusion regimen); AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18848_18817_R","Initial 1 (induction treatment covering the first 12 weeks in a patient untreated with targeted therapy)","AUTHORITY_REQUIRED","18817","18848","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (induction treatment covering the first 12 weeks in a patient untreated with targeted therapy)</p><br/><p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; or</p> <p>Patient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(c) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(d) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(e) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of not achieving an adequate response to prior therapy must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 12 weeks of treatment with upadacitinib may be requested under the Balance of supply restriction.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (induction treatment covering the first 12 weeks in a patient untreated with targeted therapy)</p><br/><p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; or</p> <p>Patient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(c) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(d) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(e) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of not achieving an adequate response to prior therapy must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 12 weeks of treatment with upadacitinib may be requested under the Balance of supply restriction.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18850_18869_R","Continuing treatment","STREAMLINED","18869","18850","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; or</p> <p>Patient must have both: (i) a total PCDAI score of 30 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; or</p> <p>Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; or</p> <p>Patient must have both: (i) a total PCDAI score of 30 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; or</p> <p>Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18851_18780_R","Initial treatment 2 - Change of treatment","AUTHORITY_REQUIRED","18780","18851","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 2 - Change of treatment</p><br/><p>Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Swapping between PAH agents: <br/>Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent&apos;s restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.</p><p align=""justify"">Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 2 - Change of treatment</p><br/><p>Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Swapping between PAH agents: <br/>Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent&apos;s restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.</p><p align=""justify"">Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18853_18884_R","Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)","AUTHORITY_REQUIRED","18884","18853","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; or</p> <p>Patient must be undergoing continuing treatment with dual combination therapy consisting of endothelin receptor antagonist with phosphodiesterase-5 inhibitor where one drug was prescribed as a non-PBS benefit; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND</p> <p>Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; or</p> <p>Patient must be undergoing continuing treatment with dual combination therapy consisting of endothelin receptor antagonist with phosphodiesterase-5 inhibitor where one drug was prescribed as a non-PBS benefit; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">If this authority application is to continue combination therapy, but with a change in at least one agent, the &apos;Initial 3 - change&apos; treatment phase restriction of the new drug(s) outlines the continuing eligibility of that new drug.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18855_18876_R","Initial treatment 2 - Change of treatment","AUTHORITY_REQUIRED","18876","18855","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 2 - Change of treatment</p><br/><p>Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Swapping between PAH agents: <br/>Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent&apos;s restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.</p><p align=""justify"">Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 2 - Change of treatment</p><br/><p>Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Swapping between PAH agents: <br/>Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent&apos;s restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.</p><p align=""justify"">Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18857_18888_R","null","AUTHORITY_REQUIRED","18888","18857","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-small cell lung cancer (NSCLC)</p><br/><p>Patient must be each of: (i) initiating treatment with this drug; (ii) have not previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be continuing treatment with this drug for this condition, with an absence of further disease progression while being treated with this drug; AND</p> <p>Patient must have/have had a WHO performance status of no greater than 2 at treatment initiation with this drug for this condition; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material; AND</p> <p>Patient must not have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to once per lifetime at any disease stage for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p> <p align=""justify"">Prescribers must refer to this drug&apos;s approved Therapeutic Goods Administration (TGA) Product Information (PI) for the relevant dosing regimens and treatment duration for the specific stage of NSCLC.</p><p align=""justify"">For patients receiving treatment with this drug as adjuvant therapy, treatment must cease upon disease progression, or after the completion of three years from the first administered dose, whichever comes first.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-small cell lung cancer (NSCLC)</p><br/><p>Patient must be each of: (i) initiating treatment with this drug; (ii) have not previously received PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must be continuing treatment with this drug for this condition, with an absence of further disease progression while being treated with this drug; AND</p> <p>Patient must have/have had a WHO performance status of no greater than 2 at treatment initiation with this drug for this condition; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material; AND</p> <p>Patient must not have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p> <p align=""justify"">PBS-subsidised treatment with this drug is restricted to once per lifetime at any disease stage for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).</p> <p align=""justify"">Prescribers must refer to this drug&apos;s approved Therapeutic Goods Administration (TGA) Product Information (PI) for the relevant dosing regimens and treatment duration for the specific stage of NSCLC.</p><p align=""justify"">For patients receiving treatment with this drug as adjuvant therapy, treatment must cease upon disease progression, or after the completion of three years from the first administered dose, whichever comes first.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18861_18904_R","Continuing treatment","AUTHORITY_REQUIRED","18904","18861","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; or</p> <p>Patient must have demonstrated an adequate response to treatment with this drug (in any form); AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">At the time of the authority application, medical practitioners must request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""left"">If fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the continuing treatment period.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; or</p> <p>Patient must have demonstrated an adequate response to treatment with this drug (in any form); AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">At the time of the authority application, medical practitioners must request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""left"">If fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the continuing treatment period.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18862_18906_R","Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)","AUTHORITY_REQUIRED","18906","18862","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment; and</p><p align=""left"">(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline CDAI score and the date of assessment; and/or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment; and</p><p align=""left"">(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline CDAI score and the date of assessment; and/or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18864_18809_R","Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient","AUTHORITY_REQUIRED","18809","18864","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient</p><br/><p>Patient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program); AND</p> <p>Patient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition; AND</p> <p>Patient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""left"">Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend treatment beyond 24 weeks.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">A patient may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient</p><br/><p>Patient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program); AND</p> <p>Patient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition; AND</p> <p>Patient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""left"">Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend treatment beyond 24 weeks.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">A patient may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18865_18897_R","Balance of supply","AUTHORITY_REQUIRED","18897","18865","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Continuing (maintenance) treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Continuing (maintenance) treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18868_18868_R","Continuing treatment","STREAMLINED","18868","18868","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">A maximum quantity to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose will be authorised.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">A maximum quantity to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose will be authorised.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18873_18827_R","Balance of supply","AUTHORITY_REQUIRED","18827","18873","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial or continuing restriction (Initial 1, Initial 2, Initial 3, Continuing, or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial or continuing restriction (Initial 1, Initial 2, Initial 3, Continuing, or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18875_18741_R","Initial treatment 2 - Change of treatment","AUTHORITY_REQUIRED","18741","18875","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 2 - Change of treatment</p><br/><p>Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Swapping between PAH agents: <br/>Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent&apos;s restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.</p><p align=""justify"">Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment 2 - Change of treatment</p><br/><p>Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND</p> <p>The treatment must be the sole PBS-subsidised PAH agent for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align=""justify"">PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align=""justify"">Swapping between PAH agents: <br/>Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent&apos;s restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.</p><p align=""justify"">Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.</p> <p align=""justify"">The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.</p><p align=""justify"">A maximum of 5 repeats may be requested.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18880_18759_R","Continuing treatment","AUTHORITY_REQUIRED","18759","18880","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; or</p> <p>Patient must have demonstrated an adequate response to treatment with this drug (in any form); AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">A maximum quantity and number of repeats of this drug consisting of one vial of 300 mg per dose, with up to 2 repeats will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the continuing treatment period.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; or</p> <p>Patient must have demonstrated an adequate response to treatment with this drug (in any form); AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">A maximum quantity and number of repeats of this drug consisting of one vial of 300 mg per dose, with up to 2 repeats will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the continuing treatment period.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18881_18806_R","Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient","AUTHORITY_REQUIRED","18806","18881","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient</p><br/><p>Patient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program); AND</p> <p>Patient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition; AND</p> <p>Patient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">A maximum quantity and number of repeats of this drug consisting of one vial of 300 mg per dose, with up to 2 repeats will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend beyond 24 weeks.</p> <p align=""left"">A patient may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient</p><br/><p>Patient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program); AND</p> <p>Patient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition; AND</p> <p>Patient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">A maximum quantity and number of repeats of this drug consisting of one vial of 300 mg per dose, with up to 2 repeats will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend beyond 24 weeks.</p> <p align=""left"">A patient may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18882_18907_R","null","STREAMLINED","18907","18882","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe primary axillary hyperhidrosis</p><br/><p>Patient must have previously failed topical aluminium chloride after one to two months of treatment; or</p> <p>Patient must be intolerant to topical aluminium chloride treatment; AND</p> <p>Patient must be aged 12 years or older; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a paediatrician; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Maximum number of treatments per year is 3, with no less than 4 months to elapse between treatments.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe primary axillary hyperhidrosis</p><br/><p>Patient must have previously failed topical aluminium chloride after one to two months of treatment; or</p> <p>Patient must be intolerant to topical aluminium chloride treatment; AND</p> <p>Patient must be aged 12 years or older; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a paediatrician; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Maximum number of treatments per year is 3, with no less than 4 months to elapse between treatments.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18883_18908_R","null","RESTRICTED","18908","18883","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have at least one of the following prior to having the latest PBS-subsidised prescription issued: (i) a negative HIV test result no older than 4 weeks, (ii) evidence that an HIV test has been conducted, but the result is still forthcoming.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection</p><br/><p>The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND</p> <p>Patient must have at least one of the following prior to having the latest PBS-subsidised prescription issued: (i) a negative HIV test result no older than 4 weeks, (ii) evidence that an HIV test has been conducted, but the result is still forthcoming.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18885_18885_R","Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient","AUTHORITY_REQUIRED","18885","18885","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient</p><br/><p>Patient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program); AND</p> <p>Patient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition; AND</p> <p>Patient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""left"">A maximum number of repeats of this drug consisting of up to 1 repeat for patients whose dosing frequency is every 12 weeks and up to 2 repeats for patients whose dosing frequency is every 8 weeks, will be authorised.</p> <p align=""left"">Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend treatment beyond 24 weeks.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">A patient may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient</p><br/><p>Patient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program); AND</p> <p>Patient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition; AND</p> <p>Patient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""left"">A maximum number of repeats of this drug consisting of up to 1 repeat for patients whose dosing frequency is every 12 weeks and up to 2 repeats for patients whose dosing frequency is every 8 weeks, will be authorised.</p> <p align=""left"">Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend treatment beyond 24 weeks.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">A patient may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18886_18723_R","First continuing treatment (Whole body)","AUTHORITY_REQUIRED","18723","18886","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment (Whole body)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""left"">The assessment of response to treatment must be provided in this application and documented in the patient&apos;s medical records.</p> <p>The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment (Whole body)</p><br/><p>Must be treated by a dermatologist; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>The treatment must be as systemic monotherapy; or</p> <p>The treatment must be in combination with methotrexate; AND</p> <p>Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND</p> <p>Patient must have demonstrated an adequate response to treatment; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""left"">The assessment of response to treatment must be provided in this application and documented in the patient&apos;s medical records.</p> <p>The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.</p>","N","N","N","FULL","ALL","N","2026-07-01","Y","4708"
"18887_18826_R","Continuing treatment","AUTHORITY_REQUIRED","18826","18887","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">A maximum number of repeats of this drug consisting of up to 1 repeat for patients whose dosing frequency is every 12 weeks and up to 2 repeats for patients whose dosing frequency is every 8 weeks, will be authorised.</p> <p align=""left"">Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested by applying through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the continuing treatment period.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""left"">A maximum number of repeats of this drug consisting of up to 1 repeat for patients whose dosing frequency is every 12 weeks and up to 2 repeats for patients whose dosing frequency is every 8 weeks, will be authorised.</p> <p align=""left"">Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested by applying through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the continuing treatment period.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18890_18736_R","Grandfather arrangement - Transitioning from non-PBS-subsidised treatment","AUTHORITY_REQUIRED","18736","18890","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or chemotherapy refractory Peripheral T-cell Lymphoma</p><br/><p>Grandfather arrangement - Transitioning from non-PBS-subsidised treatment</p><br/><p>Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 July 2026; AND</p> <p>The condition must be relapsed or chemotherapy refractory; AND</p> <p>Patient must have undergone appropriate prior front-line curative intent chemotherapy prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed progressive disease while receiving treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or chemotherapy refractory Peripheral T-cell Lymphoma</p><br/><p>Grandfather arrangement - Transitioning from non-PBS-subsidised treatment</p><br/><p>Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 July 2026; AND</p> <p>The condition must be relapsed or chemotherapy refractory; AND</p> <p>Patient must have undergone appropriate prior front-line curative intent chemotherapy prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed progressive disease while receiving treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18891_6134_R","null","STREAMLINED","6134","18891","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylothorax</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylothorax</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18892_4651_R","null","RESTRICTED","4651","18892","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperlipoproteinaemia type 1</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperlipoproteinaemia type 1</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18893_18860_R","Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)","AUTHORITY_REQUIRED","18860","18893","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment; and</p><p align=""left"">(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline CDAI score and the date of assessment; and/or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) if applicable, the date of the most recent clinical assessment; and</p><p align=""left"">(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline CDAI score and the date of assessment; and/or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18894_18863_R","Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)","AUTHORITY_REQUIRED","18863","18894","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of flared disease must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of flared disease must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18895_18807_R","Balance of supply","AUTHORITY_REQUIRED","18807","18895","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial or continuing restriction (Initial 1, Initial 2, Initial 3, Continuing, or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment); AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial or continuing restriction (Initial 1, Initial 2, Initial 3, Continuing, or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment); AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology].</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18900_18789_R","Transitioning from non-PBS to PBS-subsidised treatment - Grandfathering treatment - Treatment refractory gMG patients","AUTHORITY_REQUIRED","18789","18900","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfathering treatment - Treatment refractory gMG patients</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 July 2026; AND</p> <p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must have had a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND</p> <p>The treatment must provide no more than 6 months of therapy under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include:</p><p align=""justify"">(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];</p><p align=""justify"">(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessment was conducted);</p><p align=""justify"">(c) the MG-ADL and MGC scores assessed from the most recent course of treatment demonstrating clinical improvement to treatment (include the date the assessment was conducted).</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A retrospective assessment for one of the MGC score or MG-ADL score after completing the 12 months remission inducing treatments can be accepted for grandfathered patients in cases where it was not conducted prior to commencing non-PBS-subsidised treatment for this indication.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Treatment refractory generalised myasthenia gravis (gMG)</p><br/><p>Transitioning from non-PBS to PBS-subsidised treatment - Grandfathering treatment - Treatment refractory gMG patients</p><br/><p>Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 July 2026; AND</p> <p>Patient must have a diagnosis of MGFA Disease Class II to IV; AND</p> <p>Patient must have a positive serology for acetylcholine receptor (AChR) binding autoantibodies; AND</p> <p>Patient must not be experiencing a myasthenic crisis; AND</p> <p>Patient must not be receiving concomitant treatment with any of the following: (i) another gMG biological agent, (ii) immunoglobulin, (iii) plasma exchange (PLEX), (iv) rituximab for this condition; AND</p> <p>Patient must be receiving concomitant treatment with a non-steroidal immunosuppressant (NS-IST); or</p> <p>Patient must have had a thymectomy; AND</p> <p>Patient must have had a MG-ADL score of 6 (or higher) and a MGC score of 10 (or higher), despite having undergone 2 of the following 3 remission inducing treatments: (i) NS-IST for a minimum of 12 months, (ii) oral corticosteroids for a minimum of 12 months, (iii) a thymectomy; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MG-ADL score of at least 2 points from baseline; AND</p> <p>Patient must have demonstrated a clinical improvement based on a decrease in MGC score of at least 3 points from baseline; AND</p> <p>The treatment must provide no more than 6 months of therapy under this restriction; AND</p> <p>Must be treated by a prescriber who is either: (i) a neurologist; (ii) a clinical immunologist with expertise in the treatment of myasthenia gravis; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with an agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.</p> <p align=""justify"">The authority application must be via the Online PBS Authorities System, or in writing and must include:</p><p align=""justify"">(a) details of remission-inducing treatments [date commencement and duration of drug therapy including drug names and dosages, and/or date of the thymectomy];</p><p align=""justify"">(b) the baseline MG-ADL and MGC scores assessed after completing the 12 months of remission-inducing treatments (include the date the assessment was conducted);</p><p align=""justify"">(c) the MG-ADL and MGC scores assessed from the most recent course of treatment demonstrating clinical improvement to treatment (include the date the assessment was conducted).</p><p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">A retrospective assessment for one of the MGC score or MG-ADL score after completing the 12 months remission inducing treatments can be accepted for grandfathered patients in cases where it was not conducted prior to commencing non-PBS-subsidised treatment for this indication.</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","Y","4708"
"18901_18901_R","Adjuvant therapy","AUTHORITY_REQUIRED","18901","18901","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected non-small cell lung cancer (NSCLC)</p><br/><p>Adjuvant therapy</p><br/><p>Patient must be both: (i) initiating treatment, (ii) untreated with an Anaplastic Lymphoma Kinase-Tyrosine Kinase Inhibitor (ALK-TKI) for non-small cell lung cancer; or</p> <p>Patient must be continuing existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS-subsidised supply of this drug, (ii) untreated with ALK-TKI at the time this drug was initiated; AND</p> <p>The condition must be/have been at least one of: (i) node positive, (ii) at least 4 cm in size; AND</p> <p>The treatment must be for the purpose of adjuvant therapy following surgical resection; AND</p> <p>The treatment must be commenced within 26 weeks of surgery; AND</p> <p>Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 24 months of combined non-PBS and PBS-subsidised treatment for this condition from the first administered dose; mark any remaining repeat prescriptions with the words ''cancelled'' where (i)/(ii) has occurred; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Resected non-small cell lung cancer (NSCLC)</p><br/><p>Adjuvant therapy</p><br/><p>Patient must be both: (i) initiating treatment, (ii) untreated with an Anaplastic Lymphoma Kinase-Tyrosine Kinase Inhibitor (ALK-TKI) for non-small cell lung cancer; or</p> <p>Patient must be continuing existing PBS-subsidised treatment with this drug; or</p> <p>Patient must be both: (i) transitioning from existing non-PBS to PBS-subsidised supply of this drug, (ii) untreated with ALK-TKI at the time this drug was initiated; AND</p> <p>The condition must be/have been at least one of: (i) node positive, (ii) at least 4 cm in size; AND</p> <p>The treatment must be for the purpose of adjuvant therapy following surgical resection; AND</p> <p>The treatment must be commenced within 26 weeks of surgery; AND</p> <p>Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND</p> <p>Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 24 months of combined non-PBS and PBS-subsidised treatment for this condition from the first administered dose; mark any remaining repeat prescriptions with the words ''cancelled'' where (i)/(ii) has occurred; AND</p> <p>Must be treated by a medical practitioner; or</p> <p>Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18902_18793_R","Grandfathering arrangements - Transitioning from non-PBS to PBS-subsidised supply","AUTHORITY_REQUIRED","18793","18902","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Grandfathering arrangements - Transitioning from non-PBS to PBS-subsidised supply</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received non-PBS-subsidised treatment with this biological medicine for this PBS indication prior to 1 July 2026; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have had a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have had a duration of asthma of at least 1 year prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have had blood eosinophil count of at least 300 cells per microlitre in the 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have had blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have had total serum human immunoglobulin E of at least 30 IU/mL, measured in the 12 months prior to initiation of non-PBS subsidised treatment with this drug for this condition that had past or current evidence of atopy, documented by either: (i) skin prick testing; or (ii) an in vitro measure of specific IgE no more than 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have documented a failure to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment with this drug if the patient has received at least 28 weeks of treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the month prior to starting treatment with this drug, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the 12 months prior to starting treatment with this drug, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of tezepelumab sufficient for up to 32 weeks of therapy, at a dose of 210 mg every four weeks.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and</p><p align=""justify"">(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(e) if applicable, the eosinophil count and date; and</p><p align=""justify"">(f) if applicable, the IgE result and date.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p>A patient may qualify for PBS-subsidised treatment under this restriction once only.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Grandfathering arrangements - Transitioning from non-PBS to PBS-subsidised supply</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must have received non-PBS-subsidised treatment with this biological medicine for this PBS indication prior to 1 July 2026; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have had a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have had a duration of asthma of at least 1 year prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have had blood eosinophil count of at least 300 cells per microlitre in the 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have had blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; or</p> <p>Patient must have had total serum human immunoglobulin E of at least 30 IU/mL, measured in the 12 months prior to initiation of non-PBS subsidised treatment with this drug for this condition that had past or current evidence of atopy, documented by either: (i) skin prick testing; or (ii) an in vitro measure of specific IgE no more than 12 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have documented a failure to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment with this drug if the patient has received at least 28 weeks of treatment with this drug for this condition; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the month prior to starting treatment with this drug, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the 12 months prior to starting treatment with this drug, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of tezepelumab sufficient for up to 32 weeks of therapy, at a dose of 210 mg every four weeks.</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and</p><p align=""justify"">(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(e) if applicable, the eosinophil count and date; and</p><p align=""justify"">(f) if applicable, the IgE result and date.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p>A patient may qualify for PBS-subsidised treatment under this restriction once only.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p>","N","N","N","FULL","ALL","N","2026-07-01","Y","4708"
"18903_18889_R","Initial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)","AUTHORITY_REQUIRED","18889","18903","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; or</p> <p>Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; or</p> <p>Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; or</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the last 12 months that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter.</p><p align=""justify"">A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and</p><p align=""justify"">(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(e) if applicable, the eosinophil count and date; and</p><p align=""justify"">(f) if applicable, the IgE result and date.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uncontrolled severe asthma</p><br/><p>Initial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)</p><br/><p>Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma; AND</p> <p>Patient must be under the care of the same physician for at least 6 months; or</p> <p>Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; or</p> <p>Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND</p> <p>Patient must have a diagnosis of asthma confirmed and documented in the patient''s medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; or</p> <p>Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient''s medical records; AND</p> <p>Patient must have a duration of asthma of at least 1 year; AND</p> <p>Patient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; or</p> <p>Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; or</p> <p>Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the last 12 months that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient''s medical records; AND</p> <p>Patient must not receive more than 32 weeks of treatment under this restriction; AND</p> <p>The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND</p> <p>Patient must be aged 12 years or older.</p> <p align=""justify"">Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.</p><p align=""justify"">If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.</p> <p align=""justify"">The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:</p><p align=""justify"">(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND</p><p align=""justify"">(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.</p><p align=""justify"">The Asthma Control Questionnaire (5 item version) assessment of the patient&apos;s response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.</p><p align=""justify"">This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.</p><p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.</p><p align=""justify"">A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">A multidisciplinary severe asthma clinic team comprises of:</p><p align=""justify"">(i) A respiratory physician; and</p><p align=""justify"">(ii) A pharmacist, nurse or asthma educator.</p><p align=""justify"">At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter.</p><p align=""justify"">A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">The following must be provided at the time of application and documented in the patient&apos;s medical records:</p><p align=""justify"">(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and</p><p align=""justify"">(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and</p><p align=""justify"">(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and</p><p align=""justify"">(d) Asthma Control Questionnaire (ACQ-5) score; and</p><p align=""justify"">(e) if applicable, the eosinophil count and date; and</p><p align=""justify"">(f) if applicable, the IgE result and date.</p> <p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the accepted toxicities, including severity, which will be accepted for the purposes of exempting a patient from the requirement of treatment with optimised asthma therapy.</p> <p align=""justify"">Formal assessment and correction of inhaler technique should be performed in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique (available at www.nationalasthma.org.au); the assessment and adherence to correct technique should be documented in the patient&apos;s medical records. Patients can obtain support with inhaler technique through their local Asthma Foundation (1800 645 130).</p>","N","N","N","FULL","ALL","N","2026-07-01","Y","4708"
"18905_18805_R","Initial 1 (new patient)","AUTHORITY_REQUIRED","18805","18905","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; or</p> <p>Patient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(c) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(d) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(e) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of not achieving an adequate response to prior therapy must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; or</p> <p>Patient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(c) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(d) if applicable, the CDAI score and the date of assessment; and</p><p align=""left"">(e) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of not achieving an adequate response to prior therapy must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18910_18849_R","Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)","AUTHORITY_REQUIRED","18849","18910","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy; AND</p> <p>The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of flared disease must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy; AND</p> <p>The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND</p> <p>Patient must be at least 18 years of age.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, current CDAI score and the date of assessment; and</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and</p><p align=""left"">(c) the date of the most recent clinical assessment.</p> <p align=""left"">Evidence of flared disease must include at least one of the following:</p><p align=""left"">(a) patient must have evidence of intestinal inflammation;</p><p align=""left"">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align=""left"">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align=""left"">Evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""justify"">A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.</p> <p align=""left"">If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p>Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align=""left"">A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <p align=""left"">A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18911_18872_R","Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application","AUTHORITY_REQUIRED","18872","18911","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; prior monotherapy has been inadequate - the patient has at least WHO functional class III PAH; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate - the patient has WHO functional class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application</p><br/><p>The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or</p> <p>The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; prior monotherapy has been inadequate - the patient has at least WHO functional class III PAH; or</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate - the patient has WHO functional class IV PAH; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.</p> <p align=""justify"">Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days.</p> <p align=""justify"">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprost</p><p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p> <p align=""justify"">Where a patient has had at least one PAH agent PBS-subsidised and the other(s) non-PBS-subsidised, apply under this &apos;Initial 2&apos; treatment phase for the non-PBS-subsidised agent(s). Transitioning of the non-PBS to PBS-subsidised supply will be subject to restrictions in Initial 2. For the existing PBS-subsidised agent(s), the authority application(s) are to be through the Continuing treatment phase of that agent(s).</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18915_18914_R","Initial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a child","AUTHORITY_REQUIRED","18914","18915","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe growth hormone deficiency</p><br/><p>Initial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a child</p><br/><p>Must be treated by an endocrinologist; AND</p> <p>Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND</p> <p>Patient must have previously received non-PBS subsidised treatment with this drug for this condition as a child; AND</p> <p>Patient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; or</p> <p>Patient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; or</p> <p>Patient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre; AND</p> <p>Patient must have a mature skeleton.</p> <p align=""justify"">Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription, specifying the active ingredient name, form and strength of the medicine, followed by the brand name; AND</p><p align=""justify"">2. A completed Severe Growth Hormone Deficiency supporting information form; AND</p><p align=""justify"">3. Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe growth hormone deficiency</p><br/><p>Initial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a child</p><br/><p>Must be treated by an endocrinologist; AND</p> <p>Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND</p> <p>Patient must have previously received non-PBS subsidised treatment with this drug for this condition as a child; AND</p> <p>Patient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; or</p> <p>Patient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; or</p> <p>Patient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre; AND</p> <p>Patient must have a mature skeleton.</p> <p align=""justify"">Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription, specifying the active ingredient name, form and strength of the medicine, followed by the brand name; AND</p><p align=""justify"">2. A completed Severe Growth Hormone Deficiency supporting information form; AND</p><p align=""justify"">3. Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-07-01","Y","4708"
"18916_18917_R","Initial treatment of late onset growth hormone deficiency","AUTHORITY_REQUIRED","18917","18916","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe growth hormone deficiency</p><br/><p>Initial treatment of late onset growth hormone deficiency</p><br/><p>Must be treated by an endocrinologist; AND</p> <p>Patient must have onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease diagnosed at chronological age of 18 years or older; or</p> <p>Patient must have onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years; AND</p> <p>Patient must have a diagnostic insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; or</p> <p>Patient must have a diagnostic arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; or</p> <p>Patient must have a diagnostic glucagon provocation test with maximum serum GH less than 3 micrograms per litre; or</p> <p>Patient must have: (a) a chronological age of 18 years or older, (b) established hypothalamic-pituitary disease, (c) at least three documented pituitary hormone deficiencies, (d) an IGF-1 concentration lower than the sex- and age-specific lower limit of normal in a patient.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription, specifying the active ingredient name, form and strength of the medicine, followed by the brand name; AND</p><p align=""justify"">2. A completed Severe Growth Hormone Deficiency supporting information form; AND</p><p align=""justify"">3. If applicable, results of the growth hormone simulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe growth hormone deficiency</p><br/><p>Initial treatment of late onset growth hormone deficiency</p><br/><p>Must be treated by an endocrinologist; AND</p> <p>Patient must have onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease diagnosed at chronological age of 18 years or older; or</p> <p>Patient must have onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years; AND</p> <p>Patient must have a diagnostic insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; or</p> <p>Patient must have a diagnostic arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; or</p> <p>Patient must have a diagnostic glucagon provocation test with maximum serum GH less than 3 micrograms per litre; or</p> <p>Patient must have: (a) a chronological age of 18 years or older, (b) established hypothalamic-pituitary disease, (c) at least three documented pituitary hormone deficiencies, (d) an IGF-1 concentration lower than the sex- and age-specific lower limit of normal in a patient.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription, specifying the active ingredient name, form and strength of the medicine, followed by the brand name; AND</p><p align=""justify"">2. A completed Severe Growth Hormone Deficiency supporting information form; AND</p><p align=""justify"">3. If applicable, results of the growth hormone simulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-07-01","Y","4708"
"18918_18920_R","Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a child","AUTHORITY_REQUIRED","18920","18918","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe growth hormone deficiency</p><br/><p>Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a child</p><br/><p>Must be treated by an endocrinologist; AND</p> <p>Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition as a child; AND</p> <p>Patient must have a mature skeleton.</p> <p align=""justify"">Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription, specifying the active ingredient name, form and strength of the medicine, followed by the brand name; AND</p><p align=""justify"">2. A completed Severe Growth Hormone Deficiency supporting information form.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe growth hormone deficiency</p><br/><p>Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a child</p><br/><p>Must be treated by an endocrinologist; AND</p> <p>Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition as a child; AND</p> <p>Patient must have a mature skeleton.</p> <p align=""justify"">Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">1. Details of the proposed prescription, specifying the active ingredient name, form and strength of the medicine, followed by the brand name; AND</p><p align=""justify"">2. A completed Severe Growth Hormone Deficiency supporting information form.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-07-01","Y","4708"
"18923_18924_R","Continuing sole PBS-subsidised supply for anticipated emergency treatment","AUTHORITY_REQUIRED","18924","18923","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute allergic reaction with anaphylaxis</p><br/><p>Continuing sole PBS-subsidised supply for anticipated emergency treatment</p><br/><p>Patient must have previously been issued with an authority prescription for any form of this drug for this indication; AND</p> <p>Patient must be aged 4 years or older; AND</p> <p>Patient must weigh 15 kg or more.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute allergic reaction with anaphylaxis</p><br/><p>Continuing sole PBS-subsidised supply for anticipated emergency treatment</p><br/><p>Patient must have previously been issued with an authority prescription for any form of this drug for this indication; AND</p> <p>Patient must be aged 4 years or older; AND</p> <p>Patient must weigh 15 kg or more.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18925_18922_R","Continuing sole PBS-subsidised supply for anticipated emergency treatment","AUTHORITY_REQUIRED","18922","18925","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute allergic reaction with anaphylaxis</p><br/><p>Continuing sole PBS-subsidised supply for anticipated emergency treatment</p><br/><p>Patient must have previously been issued with an authority prescription for any form of this drug for this indication.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute allergic reaction with anaphylaxis</p><br/><p>Continuing sole PBS-subsidised supply for anticipated emergency treatment</p><br/><p>Patient must have previously been issued with an authority prescription for any form of this drug for this indication.</p>","N","N","N","IMMEDIATE","ALL","N","2026-07-01","N","4708"
"18926_18926_R","Initial treatment - Second-line therapy","AUTHORITY_REQUIRED","18926","18926","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Initial treatment - Second-line therapy</p><br/><p>Must be treated by a consultant physician; AND</p> <p>Patient must not have received PBS-subsidised treatment with any of: (i) teriparatide, (ii) romosozumab or (iii) abaloparatide; or</p> <p>Patient must have developed intolerance to (i) teriparatide, or (ii) romosozumab of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy; AND</p> <p>Patient must be at very high risk of fracture; AND</p> <p>Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND</p> <p>Patient must have had 2 or more fractures due to minimal trauma; AND</p> <p>Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months of PBS and non-PBS-subsidised therapy with this drug for this condition.</p> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient&apos;s medical record at the time treatment with this drug is initiated.</p> <p align=""justify"">If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient&apos;s medical record at the time treatment with this drug is initiated.</p> <p align=""justify"">Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.</p> <p align=""justify"">Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Initial treatment - Second-line therapy</p><br/><p>Must be treated by a consultant physician; AND</p> <p>Patient must not have received PBS-subsidised treatment with any of: (i) teriparatide, (ii) romosozumab or (iii) abaloparatide; or</p> <p>Patient must have developed intolerance to (i) teriparatide, or (ii) romosozumab of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy; AND</p> <p>Patient must be at very high risk of fracture; AND</p> <p>Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND</p> <p>Patient must have had 2 or more fractures due to minimal trauma; AND</p> <p>Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months of PBS and non-PBS-subsidised therapy with this drug for this condition.</p> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient&apos;s medical record at the time treatment with this drug is initiated.</p> <p align=""justify"">If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient&apos;s medical record at the time treatment with this drug is initiated.</p> <p align=""justify"">Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.</p> <p align=""justify"">Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application. </p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18928_18930_R","Continuing treatment","AUTHORITY_REQUIRED","18930","18928","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).</p>","N","N","Y","IMMEDIATE","ALL","Y","2026-08-01","N","4708"
"18929_18929_R","Grandfather arrangement (transition from LSDP-funded Fabry disease therapy)","AUTHORITY_REQUIRED","18929","18929","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Grandfather arrangement (transition from LSDP-funded Fabry disease therapy)</p><br/><p>Patient must have previously received treatment with Enzyme Replacement Therapy for this condition funded under the Australian Government''s Life Saving Drugs Program (LSDP) prior to 1 August 2026; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Grandfather arrangement (transition from LSDP-funded Fabry disease therapy)</p><br/><p>Patient must have previously received treatment with Enzyme Replacement Therapy for this condition funded under the Australian Government''s Life Saving Drugs Program (LSDP) prior to 1 August 2026; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).</p>","N","N","Y","FULL","ALL","Y","2026-08-01","Y","4708"
"18931_18931_R","Initial treatment (Cycles 1 - 5 inclusive)","AUTHORITY_REQUIRED","18931","18931","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory follicular lymphoma</p><br/><p>Initial treatment (Cycles 1 - 5 inclusive)</p><br/><p>The treatment must be/have been initiated in combination with rituximab and lenalidomide; AND</p> <p>The condition must have relapsed or been refractory to at least one prior therapy prior to initiating treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 5 cycles of treatment under this restriction.</p> <p align=""justify"">The treatment must not exceed a total of 12 cycles in a lifetime for this indication measured from the initial dose, or must not extend beyond disease progression, whichever comes first.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory follicular lymphoma</p><br/><p>Initial treatment (Cycles 1 - 5 inclusive)</p><br/><p>The treatment must be/have been initiated in combination with rituximab and lenalidomide; AND</p> <p>The condition must have relapsed or been refractory to at least one prior therapy prior to initiating treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 5 cycles of treatment under this restriction.</p> <p align=""justify"">The treatment must not exceed a total of 12 cycles in a lifetime for this indication measured from the initial dose, or must not extend beyond disease progression, whichever comes first.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18932_18932_R","null","AUTHORITY_REQUIRED","18932","18932","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory follicular lymphoma</p><br/><p>The treatment must be in combination with rituximab and tafasitamab; or</p> <p>The treatment must be in combination with tafasitamab.</p> <p align=""justify"">The treatment must not exceed a total of 12 cycles in a lifetime for this indication measured from the initial dose, or must not extend beyond disease progression, whichever comes first.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory follicular lymphoma</p><br/><p>The treatment must be in combination with rituximab and tafasitamab; or</p> <p>The treatment must be in combination with tafasitamab.</p> <p align=""justify"">The treatment must not exceed a total of 12 cycles in a lifetime for this indication measured from the initial dose, or must not extend beyond disease progression, whichever comes first.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18949_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms morphine sulfate 10 mg/mL injection and morphine hydrochloride 10 mg/mL injection are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2016-08-01","N","4708"
"18950_18950_R","Continuing treatment","AUTHORITY_REQUIRED","18950","18950","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tumour-induced osteomalacia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved normalisation in serum phosphate levels; or</p> <p>The condition must have been reviewed by a second specialist physician with expertise in the management of this condition, confirming that continuing therapy is clinically required; AND</p> <p>Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tumour-induced osteomalacia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved normalisation in serum phosphate levels; or</p> <p>The condition must have been reviewed by a second specialist physician with expertise in the management of this condition, confirming that continuing therapy is clinically required; AND</p> <p>Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2026-08-01","N","4708"
"18951_18952_R","Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised supply","AUTHORITY_REQUIRED","18952","18951","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tumour-induced osteomalacia</p><br/><p>Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised supply</p><br/><p>Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2026; AND</p> <p>Patient must have, prior to initiating treatment with this drug, a confirmed diagnosis of hypophosphataemia in tumour-induced osteomalacia demonstrated by the presence of all of the following: (i) chronic clinical symptoms of fatigue, bone pain, muscle weakness and/or (pseudo) fractures; (ii) elevated (or inappropriately normal) serum or plasma FGF-23 levels above the mean of the assay-specific reference range; (iii) a serum phosphate concentration below the age adjusted lower limit of normal; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine; AND</p> <p>Patient must not have been a candidate for curative surgical resection, prior to initiating treatment with this drug, as a result of either: (i) inability to locate the causative tumour using all available functional imaging technologies; (ii) inability to completely resect the causative tumour due to size, anatomical location, or other patient contraindications or comorbidities; or</p> <p>Patient must have had demonstrated persistent hypophosphataemia despite complete surgical resection of the suspected causative tumour prior to initiating treatment with this drug; AND</p> <p>Patient must have achieved normalisation in serum phosphate levels; or</p> <p>The condition must have been reviewed by a second specialist physician with expertise in the management of this condition, confirming that continuing therapy is clinically required; AND</p> <p>Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tumour-induced osteomalacia</p><br/><p>Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised supply</p><br/><p>Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2026; AND</p> <p>Patient must have, prior to initiating treatment with this drug, a confirmed diagnosis of hypophosphataemia in tumour-induced osteomalacia demonstrated by the presence of all of the following: (i) chronic clinical symptoms of fatigue, bone pain, muscle weakness and/or (pseudo) fractures; (ii) elevated (or inappropriately normal) serum or plasma FGF-23 levels above the mean of the assay-specific reference range; (iii) a serum phosphate concentration below the age adjusted lower limit of normal; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine; AND</p> <p>Patient must not have been a candidate for curative surgical resection, prior to initiating treatment with this drug, as a result of either: (i) inability to locate the causative tumour using all available functional imaging technologies; (ii) inability to completely resect the causative tumour due to size, anatomical location, or other patient contraindications or comorbidities; or</p> <p>Patient must have had demonstrated persistent hypophosphataemia despite complete surgical resection of the suspected causative tumour prior to initiating treatment with this drug; AND</p> <p>Patient must have achieved normalisation in serum phosphate levels; or</p> <p>The condition must have been reviewed by a second specialist physician with expertise in the management of this condition, confirming that continuing therapy is clinically required; AND</p> <p>Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2026-08-01","N","4708"
"18960_18958_R","Continuing treatment","AUTHORITY_REQUIRED","18958","18960","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary tyrosinaemia type 1 (HT-1)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>The treatment must be in combination with dietary restriction of tyrosine and phenylalanine; AND</p> <p>Must be treated by a physician with expertise in the management of HT-1; AND</p> <p>Must be treated in a centre with expertise in genetic metabolic disorders.</p> <p align=""justify"">At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Liver function tests (LFT), Full blood count (FBC) and Alpha-fetoprotein (AFP) results confirming eligibility for continuing treatment must be documented in the patient&apos;s medical records.</p><p align=""justify"">Prescribers must state the patient&apos;s body weight with every authority application, and document it in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary tyrosinaemia type 1 (HT-1)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>The treatment must be in combination with dietary restriction of tyrosine and phenylalanine; AND</p> <p>Must be treated by a physician with expertise in the management of HT-1; AND</p> <p>Must be treated in a centre with expertise in genetic metabolic disorders.</p> <p align=""justify"">At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Liver function tests (LFT), Full blood count (FBC) and Alpha-fetoprotein (AFP) results confirming eligibility for continuing treatment must be documented in the patient&apos;s medical records.</p><p align=""justify"">Prescribers must state the patient&apos;s body weight with every authority application, and document it in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18961_18962_R","null","AUTHORITY_REQUIRED","18962","18961","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Malaria</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Severe thrombocytopenia has been reported with this drug.</p> <p>Malaria</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18963_18986_R","Initial treatment","AUTHORITY_REQUIRED","18986","18963","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Type III Short bowel syndrome with intestinal failure</p><br/><p>Initial treatment</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit; AND</p> <p>Patient must have short bowel syndrome with intestinal failure following major surgery; AND</p> <p>Patient must have a history of dependence on parenteral support for at least 12 months; AND</p> <p>Patient must have received a stable parenteral support regimen for at least 3 days per week in the 4 weeks prior to commencing this drug; AND</p> <p>Patient must not have active gastrointestinal malignancy or history of gastrointestinal malignancy within the last 5 years; AND</p> <p>The treatment must not exceed 12 months under this restriction; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Provide a baseline value in this authority application of the amount of parenteral support per week, expressed as either:</p><p align=""justify"">(i) for a patient of any age, the mean number of days of parenteral support per week,</p><p align=""justify"">(ii) for a patient yet to turn 18 years of age, the mean volume of parenteral support per week in mL per kg.</p><p align=""justify"">Determine the mean over any given 4 week period prior to commencing this drug. For a patient yet to turn 18 years of age, both (i) and (ii) may be supplied, but provide at least (i).</p><p align=""justify"">Assessment of treatment response/non-response in the &apos;Continuing treatment&apos; authority application will be compared against the baseline value(s) submitted in this application.</p> <p align=""justify"">A stable parenteral support regimen is defined as a minimum of 3 days of parenteral support (parenteral nutrition with or without IV fluids) per week for 4 consecutive weeks to meet caloric, fluid or electrolyte needs.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Type III Short bowel syndrome with intestinal failure</p><br/><p>Initial treatment</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit; AND</p> <p>Patient must have short bowel syndrome with intestinal failure following major surgery; AND</p> <p>Patient must have a history of dependence on parenteral support for at least 12 months; AND</p> <p>Patient must have received a stable parenteral support regimen for at least 3 days per week in the 4 weeks prior to commencing this drug; AND</p> <p>Patient must not have active gastrointestinal malignancy or history of gastrointestinal malignancy within the last 5 years; AND</p> <p>The treatment must not exceed 12 months under this restriction; AND</p> <p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Provide a baseline value in this authority application of the amount of parenteral support per week, expressed as either:</p><p align=""justify"">(i) for a patient of any age, the mean number of days of parenteral support per week,</p><p align=""justify"">(ii) for a patient yet to turn 18 years of age, the mean volume of parenteral support per week in mL per kg.</p><p align=""justify"">Determine the mean over any given 4 week period prior to commencing this drug. For a patient yet to turn 18 years of age, both (i) and (ii) may be supplied, but provide at least (i).</p><p align=""justify"">Assessment of treatment response/non-response in the &apos;Continuing treatment&apos; authority application will be compared against the baseline value(s) submitted in this application.</p> <p align=""justify"">A stable parenteral support regimen is defined as a minimum of 3 days of parenteral support (parenteral nutrition with or without IV fluids) per week for 4 consecutive weeks to meet caloric, fluid or electrolyte needs.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","N","N","N","FULL","ALL","N","2026-08-01","Y","4708"
"18964_18966_R","Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)","AUTHORITY_REQUIRED","18966","18964","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must not have previously received this drug for this condition in this treatment cycle; or</p> <p>Patient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; or</p> <p>Patient must have: (i) received this drug in this treatment cycle, (ii) not demonstrated/maintained an adequate response to this drug once in this treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the PCDAI score and the date of assessment; or</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; clinical and treatment criteria when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline PCDAI score and the date of assessment; or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must not have previously received this drug for this condition in this treatment cycle; or</p> <p>Patient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; or</p> <p>Patient must have: (i) received this drug in this treatment cycle, (ii) not demonstrated/maintained an adequate response to this drug once in this treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the PCDAI score and the date of assessment; or</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; clinical and treatment criteria when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline PCDAI score and the date of assessment; or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18965_18989_R","Balance of supply","AUTHORITY_REQUIRED","18989","18965","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial restriction (Initial 1, 2 or 3); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial restriction (Initial 1, 2 or 3); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18969_18991_R","Continuing treatment","STREAMLINED","18991","18969","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have both: (i) a total PCDAI score of 40 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; or</p> <p>Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition under this treatment phase. Patients may re-trial treatment with this drug under the &apos;Initial 2&apos; treatment phase if eligible. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have both: (i) a total PCDAI score of 40 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; or</p> <p>Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition under this treatment phase. Patients may re-trial treatment with this drug under the &apos;Initial 2&apos; treatment phase if eligible. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18970_18992_R","Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)","AUTHORITY_REQUIRED","18992","18970","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND</p> <p>Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease while off treatment with targeted therapy; AND</p> <p>Patient must not receive more than 12-14 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) current PCDAI score and the date of assessment; or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">For patients assessed as having extensive intestinal inflammation of the small intestines, such evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">If fewer than 3 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p align=""left"">Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""left"">An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight with 3 repeats will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND</p> <p>Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease while off treatment with targeted therapy; AND</p> <p>Patient must not receive more than 12-14 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) current PCDAI score and the date of assessment; or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">For patients assessed as having extensive intestinal inflammation of the small intestines, such evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">If fewer than 3 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p align=""left"">Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""left"">An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight with 3 repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2026-08-01","N","4708"
"18971_18993_R","Balance of supply","AUTHORITY_REQUIRED","18993","18971","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial restriction (Initial 1, 2 or 3); AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Patient must have received insufficient treatment with this drug for this condition under any relevant initial restriction (Initial 1, 2 or 3); AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18973_18973_R","Initial treatment - First-line therapy","AUTHORITY_REQUIRED","18973","18973","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Initial treatment - First-line therapy</p><br/><p>Must be treated by a consultant physician; AND</p> <p>Patient must not have received PBS-subsidised treatment with any of: (i) anti-resorptive therapy, (ii) teriparatide, (iii) romosozumab, or (iv) abaloparatide; or</p> <p>Patient must have developed intolerance to romosozumab of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy; AND</p> <p>Patient must be at very high risk of fracture; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must have had a symptomatic fracture due to minimal trauma; AND</p> <p>Patient must have had at least 1 hip or symptomatic vertebral fracture in the previous 24 months; or</p> <p>Patient must have had at least 2 fractures including 1 symptomatic new fracture in the previous 24 months; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months of PBS and non-PBS-subsidised therapy with this drug for this condition.</p> <p align=""justify"">Details of fracture history including the date(s), site(s), the symptoms associated with the fracture(s) and the score of the qualifying BMD measurement must be provided at the time of application.</p> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive therapies for osteoporosis include alendronate sodium, risedronate sodium, raloxifene hydrochloride, denosumab and zoledronic acid.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Initial treatment - First-line therapy</p><br/><p>Must be treated by a consultant physician; AND</p> <p>Patient must not have received PBS-subsidised treatment with any of: (i) anti-resorptive therapy, (ii) teriparatide, (iii) romosozumab, or (iv) abaloparatide; or</p> <p>Patient must have developed intolerance to romosozumab of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy; AND</p> <p>Patient must be at very high risk of fracture; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must have had a symptomatic fracture due to minimal trauma; AND</p> <p>Patient must have had at least 1 hip or symptomatic vertebral fracture in the previous 24 months; or</p> <p>Patient must have had at least 2 fractures including 1 symptomatic new fracture in the previous 24 months; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months of PBS and non-PBS-subsidised therapy with this drug for this condition.</p> <p align=""justify"">Details of fracture history including the date(s), site(s), the symptoms associated with the fracture(s) and the score of the qualifying BMD measurement must be provided at the time of application.</p> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive therapies for osteoporosis include alendronate sodium, risedronate sodium, raloxifene hydrochloride, denosumab and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18974_18927_R","Initial treatment - Second-line therapy","AUTHORITY_REQUIRED","18927","18974","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Initial treatment - Second-line therapy</p><br/><p>Patient must be at very high risk of fracture; AND</p> <p>Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND</p> <p>Patient must have had 2 or more fractures due to minimal trauma; AND</p> <p>Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND</p> <p>Patient must not have received PBS-subsidised treatment with any of: (i) teriparatide, (ii) abaloparatide, or (iii) romosozumab; or</p> <p>Patient must have developed intolerance to: (i) teriparatide, or (ii) abaloparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy; AND</p> <p>Must be treated by a consultant physician.</p> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient&apos;s medical record at the time treatment with this drug is initiated.</p> <p align=""justify"">If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient&apos;s medical record at the time treatment with this drug is initiated.</p> <p align=""justify"">Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.</p> <p align=""justify"">Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Initial treatment - Second-line therapy</p><br/><p>Patient must be at very high risk of fracture; AND</p> <p>Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND</p> <p>Patient must have had 2 or more fractures due to minimal trauma; AND</p> <p>Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND</p> <p>Patient must not have received PBS-subsidised treatment with any of: (i) teriparatide, (ii) abaloparatide, or (iii) romosozumab; or</p> <p>Patient must have developed intolerance to: (i) teriparatide, or (ii) abaloparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy; AND</p> <p>Must be treated by a consultant physician.</p> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient&apos;s medical record at the time treatment with this drug is initiated.</p> <p align=""justify"">If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient&apos;s medical record at the time treatment with this drug is initiated.</p> <p align=""justify"">Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.</p> <p align=""justify"">Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application. </p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18976_18976_R","Continuing treatment (Cycles 6 - 12 inclusive)","AUTHORITY_REQUIRED","18976","18976","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory follicular lymphoma</p><br/><p>Continuing treatment (Cycles 6 - 12 inclusive)</p><br/><p>The treatment must be in combination with lenalidomide; AND</p> <p>Patient must have previously received treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 7 cycles of treatment under this restriction; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">The treatment must not exceed a total of 12 cycles in a lifetime for this indication measured from the initial dose, or must not extend beyond disease progression, whichever comes first.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory follicular lymphoma</p><br/><p>Continuing treatment (Cycles 6 - 12 inclusive)</p><br/><p>The treatment must be in combination with lenalidomide; AND</p> <p>Patient must have previously received treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a total of 7 cycles of treatment under this restriction; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">The treatment must not exceed a total of 12 cycles in a lifetime for this indication measured from the initial dose, or must not extend beyond disease progression, whichever comes first.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18981_18982_R","Initial treatment - New patient","AUTHORITY_REQUIRED","18982","18981","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tumour-induced osteomalacia</p><br/><p>Initial treatment - New patient</p><br/><p>Patient must have a confirmed diagnosis of hypophosphataemia in tumour-induced osteomalacia demonstrated by the presence of all of the following: (i) chronic clinical symptoms of fatigue, bone pain, muscle weakness and/or (pseudo) fractures; (ii) elevated (or inappropriately normal) serum or plasma FGF-23 levels above the mean of the assay-specific reference range; (iii) a serum phosphate concentration below the age adjusted lower limit of normal; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine; AND</p> <p>Patient must not be a candidate for curative surgical resection as a result of either: (i) inability to locate the causative tumour using all available functional imaging technologies; (ii) inability to completely resect the causative tumour due to size, anatomical location, or other patient contraindications or comorbidities; or</p> <p>Patient must have demonstrated persistent hypophosphataemia despite complete surgical resection of the suspected causative tumour; AND</p> <p>Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Prescribers should, where possible, rule out all other non-hereditary forms of FGF-23 related hypophosphataemia such as Fanconi syndrome, iron-infusion associated hypophosphataemia or post renal transplantation hypophosphataemia, prior to initiating patients on burosumab treatment for this condition.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tumour-induced osteomalacia</p><br/><p>Initial treatment - New patient</p><br/><p>Patient must have a confirmed diagnosis of hypophosphataemia in tumour-induced osteomalacia demonstrated by the presence of all of the following: (i) chronic clinical symptoms of fatigue, bone pain, muscle weakness and/or (pseudo) fractures; (ii) elevated (or inappropriately normal) serum or plasma FGF-23 levels above the mean of the assay-specific reference range; (iii) a serum phosphate concentration below the age adjusted lower limit of normal; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine; AND</p> <p>Patient must not be a candidate for curative surgical resection as a result of either: (i) inability to locate the causative tumour using all available functional imaging technologies; (ii) inability to completely resect the causative tumour due to size, anatomical location, or other patient contraindications or comorbidities; or</p> <p>Patient must have demonstrated persistent hypophosphataemia despite complete surgical resection of the suspected causative tumour; AND</p> <p>Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Prescribers should, where possible, rule out all other non-hereditary forms of FGF-23 related hypophosphataemia such as Fanconi syndrome, iron-infusion associated hypophosphataemia or post renal transplantation hypophosphataemia, prior to initiating patients on burosumab treatment for this condition.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2026-08-01","N","4708"
"18983_18953_R","Continuing treatment","AUTHORITY_REQUIRED","18953","18983","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>X-linked hypophosphataemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved normalisation in serum phosphate levels; or</p> <p>The condition must have been reviewed by a second specialist physician with expertise in the management of this condition, confirming that continuing therapy is clinically required; AND</p> <p>Patient must have radiographical evidence of stabilisation/improvement in rickets in patients without growth plate fusion; AND</p> <p>Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>X-linked hypophosphataemia</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved normalisation in serum phosphate levels; or</p> <p>The condition must have been reviewed by a second specialist physician with expertise in the management of this condition, confirming that continuing therapy is clinically required; AND</p> <p>Patient must have radiographical evidence of stabilisation/improvement in rickets in patients without growth plate fusion; AND</p> <p>Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient&apos;s medical records.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2026-08-01","N","4708"
"18984_19006_R","Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply","AUTHORITY_REQUIRED","19006","18984","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the continuing treatment (whole body) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the continuing treatment (face/hand/foot) restriction to complete 24 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug under the continuing treatment (whole body) restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug under the continuing treatment (face/hand/foot) restriction to complete 24 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18988_18968_R","Initial 1 (new patient)","AUTHORITY_REQUIRED","18968","18988","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND</p> <p>Patient must not have achieved an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy with a thiopurine at a clinically optimised dose, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; or</p> <p>Patient must have a documented contraindication to each of prednisolone (or equivalent), a thiopurine, and methotrexate; or</p> <p>Patient must have features of high-risk or complicated Crohn disease defined as those with any of the following: (i) perianal disease, (ii) stricturing or penetrating behaviour, (iii) severe delayed growth (growth velocity at least 2 standard deviations below the mean for age and sex, or a drop of at least 1 major centile band); AND</p> <p>Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40; or</p> <p>Patient must have extensive intestinal inflammation of the small intestine as evidenced by radiological imaging; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) current PCDAI score and the date of assessment; or</p><p align=""left"">(c) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">For patients assessed as having extensive intestinal inflammation of the small intestines, such evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""left"">Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND</p> <p>Patient must not have achieved an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy with a thiopurine at a clinically optimised dose, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; or</p> <p>Patient must have a documented contraindication to each of prednisolone (or equivalent), a thiopurine, and methotrexate; or</p> <p>Patient must have features of high-risk or complicated Crohn disease defined as those with any of the following: (i) perianal disease, (ii) stricturing or penetrating behaviour, (iii) severe delayed growth (growth velocity at least 2 standard deviations below the mean for age and sex, or a drop of at least 1 major centile band); AND</p> <p>Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40; or</p> <p>Patient must have extensive intestinal inflammation of the small intestine as evidenced by radiological imaging; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) current PCDAI score and the date of assessment; or</p><p align=""left"">(c) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">For patients assessed as having extensive intestinal inflammation of the small intestines, such evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""left"">Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18990_18967_R","Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)","AUTHORITY_REQUIRED","18967","18990","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND</p> <p>Patient must have disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease while off treatment with targeted therapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) current PCDAI score and the date of assessment; or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">For patients assessed as having extensive intestinal inflammation of the small intestines, such evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition; AND</p> <p>Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition; AND</p> <p>Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND</p> <p>Patient must have disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40 while off treatment with targeted therapy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease while off treatment with targeted therapy; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) current PCDAI score and the date of assessment; or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">For patients assessed as having extensive intestinal inflammation of the small intestines, such evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18996_19012_R","Initial treatment","STREAMLINED","19012","18996","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist; or</p> <p>Must be treated by a consultant physician; AND</p> <p>Patient must be at very high risk of fracture; AND</p> <p>Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND</p> <p>Patient must have had 2 or more fractures due to minimal trauma; AND</p> <p>Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months therapy; AND</p> <p>Patient must not have received PBS-subsidised treatment with any of: (i) romosozumab, (ii) abaloparatide; or</p> <p>Patient must have developed intolerance to: (i) romosozumab, or (ii) abaloparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy.</p> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient&apos;s medical record at the time treatment with teriparatide is initiated. </p> <p align=""justify"">If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy<i>. </i>Details must be documented in the patient&apos;s medical record at the time treatment with teriparatide is initiated. </p> <p align=""justify"">Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.</p> <p align=""justify"">Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be documented in the patient&apos;s medical record.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Initial treatment</p><br/><p>Must be treated by a specialist; or</p> <p>Must be treated by a consultant physician; AND</p> <p>Patient must be at very high risk of fracture; AND</p> <p>Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND</p> <p>Patient must have had 2 or more fractures due to minimal trauma; AND</p> <p>Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months therapy; AND</p> <p>Patient must not have received PBS-subsidised treatment with any of: (i) romosozumab, (ii) abaloparatide; or</p> <p>Patient must have developed intolerance to: (i) romosozumab, or (ii) abaloparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy.</p> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient&apos;s medical record at the time treatment with teriparatide is initiated. </p> <p align=""justify"">If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy<i>. </i>Details must be documented in the patient&apos;s medical record at the time treatment with teriparatide is initiated. </p> <p align=""justify"">Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.</p> <p align=""justify"">Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be documented in the patient&apos;s medical record.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18997_18997_R","Continuing treatment - First-line therapy","AUTHORITY_REQUIRED","18997","18997","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Continuing treatment - First-line therapy</p><br/><p>Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition as first-line therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months of PBS and non-PBS-subsidised therapy with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Continuing treatment - First-line therapy</p><br/><p>Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition as first-line therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months of PBS and non-PBS-subsidised therapy with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"18999_18999_R","Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised treatment","STREAMLINED","18999","18999","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adult-type IDH-mutant astrocytoma or oligodendroglioma</p><br/><p>Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised treatment</p><br/><p>Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2026; AND</p> <p>Patient must have a World Health Organisation (WHO) Grade 2 astrocytoma or oligodendroglioma; AND</p> <p>Patient must have had a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation at the time of initiation of non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, at initiation of non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have had residual or recurrent disease after at least one prior surgery (biopsy, sub-total resection, or gross total resection) for this condition at the time of initiation of non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must not have been previously treated with systemic anticancer therapy prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Confirm that evidence of the presence of a susceptible IDH1 or IDH2 variant in the tumour tissue is documented/retained in the patient&apos;s medical records once only with the first PBS prescription.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adult-type IDH-mutant astrocytoma or oligodendroglioma</p><br/><p>Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised treatment</p><br/><p>Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2026; AND</p> <p>Patient must have a World Health Organisation (WHO) Grade 2 astrocytoma or oligodendroglioma; AND</p> <p>Patient must have had a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation at the time of initiation of non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, at initiation of non-PBS-subsidised treatment with this drug; AND</p> <p>Patient must have had residual or recurrent disease after at least one prior surgery (biopsy, sub-total resection, or gross total resection) for this condition at the time of initiation of non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must not have been previously treated with systemic anticancer therapy prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p> <p align=""justify"">Confirm that evidence of the presence of a susceptible IDH1 or IDH2 variant in the tumour tissue is documented/retained in the patient&apos;s medical records once only with the first PBS prescription.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p> <p/><p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Grandfathered&apos; patient must qualify under the &apos;Continuing treatment&apos; criteria. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"19001_N","null","null","null","null","null","<p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","Y","N","N","null","null","N","2016-08-01","N","4708"
"19004_N","null","null","null","null","null","<p align=""justify"">This pharmaceutical benefit is not PBS-subsidised for primary prevention of breast cancer.</p>","Y","N","N","null","null","N","2016-10-01","N","4708"
"19007_19029_R","Continuing treatment, Face, hand, foot","AUTHORITY_REQUIRED","19029","19007","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have both: (i) experienced an adequate response following the most recent course of treatment at the 100 mg dosage regimen and (ii) the treating physician determined that a more satisfactory response can be achieved at the 200 mg dosage regimen; or</p> <p>Patient must have demonstrated an adequate response to the most recent course of treatment with this drug at the 200 mg dosage regimen; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to not have responded to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient does not demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have both: (i) experienced an adequate response following the most recent course of treatment at the 100 mg dosage regimen and (ii) the treating physician determined that a more satisfactory response can be achieved at the 200 mg dosage regimen; or</p> <p>Patient must have demonstrated an adequate response to the most recent course of treatment with this drug at the 200 mg dosage regimen; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to not have responded to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient does not demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-08-01","Y","4708"
"19009_18987_R","Initial treatment","AUTHORITY_REQUIRED","18987","19009","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment</p><br/><p>Patient must have received treatment with the PBS-subsidised IV formulation of this drug for this condition; or</p> <p>Patient must have received an approved PBS authority prescription for treatment with the IV formulation of this drug for this condition; or</p> <p>Patient must not have received treatment with the IV formulation of this drug, but has met the restrictions criteria as specified in the Initial 1, 2, or 3 for the IV formulation for this condition; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p> <p align=""left"">The following information must be provided for patients who have not received the IV formulation as loading dose(s), but has met the restrictions criteria as specified in the Initial 1, 2, or 3 for the IV formulation:</p><p align=""left"">(i) reason for loading doses being omitted; and</p><p align=""left"">(ii) if applicable, details of prior systemic therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(iii) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(iv) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(v) if applicable, the PCDAI or CDAI score and the date of assessment; and</p><p align=""left"">(vi) the date of the most recent clinical assessment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment</p><br/><p>Patient must have received treatment with the PBS-subsidised IV formulation of this drug for this condition; or</p> <p>Patient must have received an approved PBS authority prescription for treatment with the IV formulation of this drug for this condition; or</p> <p>Patient must not have received treatment with the IV formulation of this drug, but has met the restrictions criteria as specified in the Initial 1, 2, or 3 for the IV formulation for this condition; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p> <p align=""left"">The following information must be provided for patients who have not received the IV formulation as loading dose(s), but has met the restrictions criteria as specified in the Initial 1, 2, or 3 for the IV formulation:</p><p align=""left"">(i) reason for loading doses being omitted; and</p><p align=""left"">(ii) if applicable, details of prior systemic therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(iii) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and</p><p align=""left"">(iv) if applicable, details of intestinal inflammation marker/s; and</p><p align=""left"">(v) if applicable, the PCDAI or CDAI score and the date of assessment; and</p><p align=""left"">(vi) the date of the most recent clinical assessment.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"19010_18995_R","Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)","AUTHORITY_REQUIRED","18995","19010","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must not have previously received this drug for this condition in this treatment cycle; or</p> <p>Patient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; or</p> <p>Patient must have: (i) received this drug in this treatment cycle, (ii) not demonstrated/maintained an adequate response to this drug once in this treatment cycle; AND</p> <p>Patient must not receive more than 12-14 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the PCDAI score and the date of assessment; or</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; clinical and treatment criteria when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline PCDAI score and the date of assessment; or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">If fewer than 3 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p align=""left"">Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""left"">An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight with 3 repeats will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Initial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; or</p> <p>Patient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; AND</p> <p>Patient must not have previously received this drug for this condition in this treatment cycle; or</p> <p>Patient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; or</p> <p>Patient must have: (i) received this drug in this treatment cycle, (ii) not demonstrated/maintained an adequate response to this drug once in this treatment cycle; AND</p> <p>Patient must not receive more than 12-14 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, the PCDAI score and the date of assessment; or</p><p align=""left"">(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all &apos;Initial 1&apos; clinical and treatment criteria when targeted therapy treatment commenced. The following information must also be provided at the time of application:</p><p align=""left"">(a) the baseline PCDAI score and the date of assessment; or</p><p align=""left"">(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">If fewer than 3 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p align=""left"">Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""left"">An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight with 3 repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2026-08-01","N","4708"
"19011_19011_R","Continuing treatment","STREAMLINED","19011","19011","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have both: (i) a total PCDAI score of 30 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; or</p> <p>Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition under this treatment phase. Patients may re-trial treatment with this drug under the &apos;Initial 2&apos; treatment phase if eligible. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""left"">An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight will be authorised.</p> <p align=""left"">An increase in maximum repeats to 5 may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have both: (i) a total PCDAI score of 30 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; or</p> <p>Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition under this treatment phase. Patients may re-trial treatment with this drug under the &apos;Initial 2&apos; treatment phase if eligible. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""left"">An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight will be authorised.</p> <p align=""left"">An increase in maximum repeats to 5 may be requested.</p>","N","N","N","IMMEDIATE","ALL","Y","2026-08-01","N","4708"
"19013_19034_R","Continuing treatment","AUTHORITY_REQUIRED","19034","19013","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by migalastat; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by migalastat; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"19014_18998_R","Grandfather arrangement (transition from LSDP-funded Fabry disease therapy)","AUTHORITY_REQUIRED","18998","19014","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Grandfather arrangement (transition from LSDP-funded Fabry disease therapy)</p><br/><p>Patient must have previously received treatment with this drug for this condition funded under the Australian Government''s Life Saving Drugs Program (LSDP) prior to 1 September 2024; or</p> <p>Patient must have previously received treatment with Enzyme Replacement Therapy for this condition funded under the Australian Government''s Life Saving Drugs Program (LSDP) prior to 1 September 2024; AND</p> <p>Patient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant prior to commencing treatment with this drug; AND</p> <p>Patient must have/have had an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2 prior to commencing treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Grandfather arrangement (transition from LSDP-funded Fabry disease therapy)</p><br/><p>Patient must have previously received treatment with this drug for this condition funded under the Australian Government''s Life Saving Drugs Program (LSDP) prior to 1 September 2024; or</p> <p>Patient must have previously received treatment with Enzyme Replacement Therapy for this condition funded under the Australian Government''s Life Saving Drugs Program (LSDP) prior to 1 September 2024; AND</p> <p>Patient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant prior to commencing treatment with this drug; AND</p> <p>Patient must have/have had an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2 prior to commencing treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-08-01","Y","4708"
"19015_19015_R","Initial treatment","AUTHORITY_REQUIRED","19015","19015","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Initial treatment</p><br/><p>Patient must have at least one of: (i) documented deficiency of alpha-galactosidase enzyme activity in blood, (ii) presence of genetic mutations known to result in deficiency of alpha-galactosidase enzyme activity; AND</p> <p>Patient must be male with Fabry-related renal disease confirmed by at least one of the following: (i) abnormal albuminuria of more than 20 mcg/min, as determined by 2 separate samples at least 24 hours apart, (ii) abnormal proteinuria of more than 150 mg/24 hours, (iii) albumin:creatinine ratio greater than upper limit of normal in 2 separate samples at least 24 hours apart, (iv) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; or</p> <p>Patient must be female with Fabry-related renal disease confirmed by at least one of the following: (i) proteinuria of more than 300 mg/24 hours with clinical evidence of progression, (ii) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; or</p> <p>Patient must have Fabry-related cardiac disease confirmed by at least one of the following: (i) left ventricular hypertrophy, as evidenced by cardiac magnetic resonance imaging (MRI) or echocardiogram data, in the absence of hypertension, (ii) significant life-threatening arrhythmia or conduction defect, (iii) late gadolinium enhancement or a low T1 on cardiac MRI; or</p> <p>Patient must have Fabry-related either: (i) ischaemic disease, (ii) cerebrovascular disease as shown on objective testing with no other cause or risk factors identified; or</p> <p>Patient must have Fabry-related uncontrolled chronic pain despite the use of recommended doses of appropriate analgesia and antiseizure medications for peripheral neuropathy; or</p> <p>Patient must have significant Fabry-related gastrointestinal symptoms despite the use of the recommended doses of appropriate pharmacological therapies; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease.</p> <p align=""justify"">If hypertension is present in patients relying their eligibility on Fabry-related cardiac disease, the prescriber must treat it optimally for at least 6 months prior to submitting the first PBS authority application.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Initial treatment</p><br/><p>Patient must have at least one of: (i) documented deficiency of alpha-galactosidase enzyme activity in blood, (ii) presence of genetic mutations known to result in deficiency of alpha-galactosidase enzyme activity; AND</p> <p>Patient must be male with Fabry-related renal disease confirmed by at least one of the following: (i) abnormal albuminuria of more than 20 mcg/min, as determined by 2 separate samples at least 24 hours apart, (ii) abnormal proteinuria of more than 150 mg/24 hours, (iii) albumin:creatinine ratio greater than upper limit of normal in 2 separate samples at least 24 hours apart, (iv) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; or</p> <p>Patient must be female with Fabry-related renal disease confirmed by at least one of the following: (i) proteinuria of more than 300 mg/24 hours with clinical evidence of progression, (ii) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; or</p> <p>Patient must have Fabry-related cardiac disease confirmed by at least one of the following: (i) left ventricular hypertrophy, as evidenced by cardiac magnetic resonance imaging (MRI) or echocardiogram data, in the absence of hypertension, (ii) significant life-threatening arrhythmia or conduction defect, (iii) late gadolinium enhancement or a low T1 on cardiac MRI; or</p> <p>Patient must have Fabry-related either: (i) ischaemic disease, (ii) cerebrovascular disease as shown on objective testing with no other cause or risk factors identified; or</p> <p>Patient must have Fabry-related uncontrolled chronic pain despite the use of recommended doses of appropriate analgesia and antiseizure medications for peripheral neuropathy; or</p> <p>Patient must have significant Fabry-related gastrointestinal symptoms despite the use of the recommended doses of appropriate pharmacological therapies; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease.</p> <p align=""justify"">If hypertension is present in patients relying their eligibility on Fabry-related cardiac disease, the prescriber must treat it optimally for at least 6 months prior to submitting the first PBS authority application.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:</p><p align=""justify"">(1) details of the proposed prescription(s); and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).</p>","N","N","Y","FULL","ALL","Y","2026-08-01","Y","4708"
"19016_19016_R","Initial treatment","STREAMLINED","19016","19016","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adult-type IDH-mutant astrocytoma or oligodendroglioma</p><br/><p>Initial treatment</p><br/><p>Patient must have a World Health Organisation (WHO) Grade 2 astrocytoma or oligodendroglioma; AND</p> <p>Patient must have a test of tumour tissue confirming the presence of a susceptible isocitrate dehydrogenase-1 (IDH1) variant or isocitrate dehydrogenase-2 (IDH2) variant; AND</p> <p>Patient must have residual or recurrent disease after at least one prior surgery (biopsy, sub-total resection, or gross total resection) for this condition; AND</p> <p>Patient must not be in immediate need of radiotherapy and/or chemotherapy for this condition; AND</p> <p>The condition must not have been previously treated with systemic anticancer therapy or radiotherapy; AND</p> <p>Patient must have either a: (i) Karnofsky Performance Score of at least 80%, (ii) Lansky Performance Score of at least 80%.</p> <p align=""justify"">Confirm that evidence of the presence of a susceptible IDH1 or IDH2 variant in the tumour tissue is documented/retained in the patient&apos;s medical records once only with the first PBS prescription.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adult-type IDH-mutant astrocytoma or oligodendroglioma</p><br/><p>Initial treatment</p><br/><p>Patient must have a World Health Organisation (WHO) Grade 2 astrocytoma or oligodendroglioma; AND</p> <p>Patient must have a test of tumour tissue confirming the presence of a susceptible isocitrate dehydrogenase-1 (IDH1) variant or isocitrate dehydrogenase-2 (IDH2) variant; AND</p> <p>Patient must have residual or recurrent disease after at least one prior surgery (biopsy, sub-total resection, or gross total resection) for this condition; AND</p> <p>Patient must not be in immediate need of radiotherapy and/or chemotherapy for this condition; AND</p> <p>The condition must not have been previously treated with systemic anticancer therapy or radiotherapy; AND</p> <p>Patient must have either a: (i) Karnofsky Performance Score of at least 80%, (ii) Lansky Performance Score of at least 80%.</p> <p align=""justify"">Confirm that evidence of the presence of a susceptible IDH1 or IDH2 variant in the tumour tissue is documented/retained in the patient&apos;s medical records once only with the first PBS prescription.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"19021_19021_R","null","STREAMLINED","19021","19021","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced or metastatic medullary thyroid cancer</p><br/><p>The condition must be unresectable with documented disease progression prior to commencing treatment with this drug; AND</p> <p>The condition must have evidence of activating RET variants in tumour material - this evidence has been obtained prior to commencing treatment with this drug; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be initiating treatment with this drug; or</p> <p>Patient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug.</p> <p align=""justify"">Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced or metastatic medullary thyroid cancer</p><br/><p>The condition must be unresectable with documented disease progression prior to commencing treatment with this drug; AND</p> <p>The condition must have evidence of activating RET variants in tumour material - this evidence has been obtained prior to commencing treatment with this drug; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be initiating treatment with this drug; or</p> <p>Patient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug.</p> <p align=""justify"">Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"19022_19042_R","Continuing treatment","STREAMLINED","19042","19022","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have both: (i) a total PCDAI score of 30 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; or</p> <p>Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition under this treatment phase. Patients may re-trial treatment with this drug under the &apos;Initial 2&apos; treatment phase if eligible. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""left"">An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight will be authorised.</p> <p align=""left"">An increase in maximum repeats to 5 may be requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND</p> <p>Patient must have both: (i) a total PCDAI score of 30 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; or</p> <p>Patient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition under this treatment phase. Patients may re-trial treatment with this drug under the &apos;Initial 2&apos; treatment phase if eligible. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""left"">An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight will be authorised.</p> <p align=""left"">An increase in maximum repeats to 5 may be requested.</p>","N","N","N","IMMEDIATE","ALL","Y","2026-08-01","N","4708"
"19023_19038_R","Initial treatment","AUTHORITY_REQUIRED","19038","19023","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Initial treatment</p><br/><p>Patient must have at least one of: (i) documented deficiency of alpha-galactosidase enzyme activity in blood, (ii) presence of genetic mutations known to result in deficiency of alpha-galactosidase enzyme activity; AND</p> <p>Patient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant; AND</p> <p>Patient must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2; AND</p> <p>Patient must be male with Fabry-related renal disease confirmed by at least one of the following: (i) abnormal albuminuria of more than 20 mcg/min, as determined by 2 separate samples at least 24 hours apart, (ii) abnormal proteinuria of more than 150 mg/24 hours, (iii) albumin:creatinine ratio greater than upper limit of normal in 2 separate samples at least 24 hours apart, (iv) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; or</p> <p>Patient must be female with Fabry-related renal disease confirmed by at least one of the following: (i) proteinuria of more than 300 mg/24 hours with clinical evidence of progression, (ii) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; or</p> <p>Patient must have Fabry-related cardiac disease confirmed by at least one of the following: (i) left ventricular hypertrophy, as evidenced by cardiac magnetic resonance imaging (MRI) or echocardiogram data, in the absence of hypertension, (ii) significant life-threatening arrhythmia or conduction defect, (iii) late gadolinium enhancement or a low T1 on cardiac MRI; or</p> <p>Patient must have Fabry-related either: (i) ischaemic disease, (ii) cerebrovascular disease as shown on objective testing with no other cause or risk factors identified; or</p> <p>Patient must have Fabry-related uncontrolled chronic pain despite the use of recommended doses of appropriate analgesia and antiseizure medications for peripheral neuropathy; or</p> <p>Patient must have significant Fabry-related gastrointestinal symptoms despite the use of the recommended doses of appropriate pharmacological therapies; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">If hypertension is present in patients relying their eligibility on Fabry-related cardiac disease, the prescriber must treat it optimally for at least 6 months prior to submitting the first PBS authority application.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Initial treatment</p><br/><p>Patient must have at least one of: (i) documented deficiency of alpha-galactosidase enzyme activity in blood, (ii) presence of genetic mutations known to result in deficiency of alpha-galactosidase enzyme activity; AND</p> <p>Patient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant; AND</p> <p>Patient must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2; AND</p> <p>Patient must be male with Fabry-related renal disease confirmed by at least one of the following: (i) abnormal albuminuria of more than 20 mcg/min, as determined by 2 separate samples at least 24 hours apart, (ii) abnormal proteinuria of more than 150 mg/24 hours, (iii) albumin:creatinine ratio greater than upper limit of normal in 2 separate samples at least 24 hours apart, (iv) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; or</p> <p>Patient must be female with Fabry-related renal disease confirmed by at least one of the following: (i) proteinuria of more than 300 mg/24 hours with clinical evidence of progression, (ii) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; or</p> <p>Patient must have Fabry-related cardiac disease confirmed by at least one of the following: (i) left ventricular hypertrophy, as evidenced by cardiac magnetic resonance imaging (MRI) or echocardiogram data, in the absence of hypertension, (ii) significant life-threatening arrhythmia or conduction defect, (iii) late gadolinium enhancement or a low T1 on cardiac MRI; or</p> <p>Patient must have Fabry-related either: (i) ischaemic disease, (ii) cerebrovascular disease as shown on objective testing with no other cause or risk factors identified; or</p> <p>Patient must have Fabry-related uncontrolled chronic pain despite the use of recommended doses of appropriate analgesia and antiseizure medications for peripheral neuropathy; or</p> <p>Patient must have significant Fabry-related gastrointestinal symptoms despite the use of the recommended doses of appropriate pharmacological therapies; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">If hypertension is present in patients relying their eligibility on Fabry-related cardiac disease, the prescriber must treat it optimally for at least 6 months prior to submitting the first PBS authority application.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) details of the proposed prescription; and</p><p align=""justify"">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-08-01","Y","4708"
"19028_19028_R","Continuing treatment, Whole body","AUTHORITY_REQUIRED","19028","19028","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have both: (i) experienced an adequate response following the most recent course of treatment at the 100 mg dosage regimen and (ii) the treating physician determined that a more satisfactory response can be achieved at the 200 mg dosage regimen; or</p> <p>Patient must have demonstrated an adequate response to the most recent course of treatment with this drug at the 200 mg dosage regimen; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to not have responded to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient does not demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have both: (i) experienced an adequate response following the most recent course of treatment at the 100 mg dosage regimen and (ii) the treating physician determined that a more satisfactory response can be achieved at the 200 mg dosage regimen; or</p> <p>Patient must have demonstrated an adequate response to the most recent course of treatment with this drug at the 200 mg dosage regimen; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be at least 18 years of age; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(a) details of the proposed prescription(s); and</p><p align=""justify"">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient&apos;s condition.</p><p align=""justify"">The most recent PASI assessment must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to not have responded to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align=""justify"">If a patient does not demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2026-08-01","Y","4708"
"19032_18959_R","Continuing treatment","AUTHORITY_REQUIRED","18959","19032","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary tyrosinaemia type 1 (HT-1)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>The treatment must be in combination with dietary restriction of tyrosine and phenylalanine; AND</p> <p>Must be treated by a physician with expertise in the management of HT-1; AND</p> <p>Must be treated in a centre with expertise in genetic metabolic disorders; AND</p> <p>Patient must be less than 18 years of age.</p> <p align=""justify"">At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Liver function tests (LFT), Full blood count (FBC) and Alpha-fetoprotein (AFP) results confirming eligibility for continuing treatment must be documented in the patient&apos;s medical records.</p><p align=""justify"">Prescribers must state the patient&apos;s body weight with every authority application, and document it in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary tyrosinaemia type 1 (HT-1)</p><br/><p>Continuing treatment</p><br/><p>Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>The treatment must be in combination with dietary restriction of tyrosine and phenylalanine; AND</p> <p>Must be treated by a physician with expertise in the management of HT-1; AND</p> <p>Must be treated in a centre with expertise in genetic metabolic disorders; AND</p> <p>Patient must be less than 18 years of age.</p> <p align=""justify"">At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Liver function tests (LFT), Full blood count (FBC) and Alpha-fetoprotein (AFP) results confirming eligibility for continuing treatment must be documented in the patient&apos;s medical records.</p><p align=""justify"">Prescribers must state the patient&apos;s body weight with every authority application, and document it in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"19033_18994_R","Initial 1 (new patient)","AUTHORITY_REQUIRED","18994","19033","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND</p> <p>Patient must not have achieved an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy with a thiopurine at a clinically optimised dose, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; or</p> <p>Patient must have a documented contraindication to each of prednisolone (or equivalent), a thiopurine, and methotrexate; or</p> <p>Patient must have features of high-risk or complicated Crohn disease defined as those with any of the following: (i) perianal disease, (ii) stricturing or penetrating behaviour, (iii) severe delayed growth (growth velocity at least 2 standard deviations below the mean for age and sex, or a drop of at least 1 major centile band); AND</p> <p>Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30; or</p> <p>Patient must have extensive intestinal inflammation of the small intestine as evidenced by radiological imaging; AND</p> <p>Patient must not receive more than 12-14 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) current PCDAI score and the date of assessment; or</p><p align=""left"">(c) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">For patients assessed as having extensive intestinal inflammation of the small intestines, such evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""left"">If fewer than 3 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p align=""left"">Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""left"">An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight with 3 repeats will be authorised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe Crohn disease</p><br/><p>Initial 1 (new patient)</p><br/><p>Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND</p> <p>Patient must not have achieved an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy with a thiopurine at a clinically optimised dose, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; or</p> <p>Patient must have a documented contraindication to each of prednisolone (or equivalent), a thiopurine, and methotrexate; or</p> <p>Patient must have features of high-risk or complicated Crohn disease defined as those with any of the following: (i) perianal disease, (ii) stricturing or penetrating behaviour, (iii) severe delayed growth (growth velocity at least 2 standard deviations below the mean for age and sex, or a drop of at least 1 major centile band); AND</p> <p>Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30; or</p> <p>Patient must have extensive intestinal inflammation of the small intestine as evidenced by radiological imaging; AND</p> <p>Patient must not receive more than 12-14 weeks of treatment under this restriction; AND</p> <p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""left"">The following information must be provided by the prescriber at the time of application and documented in the patient&apos;s medical records:</p><p align=""left"">(a) if applicable, details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and</p><p align=""left"">(b) current PCDAI score and the date of assessment; or</p><p align=""left"">(c) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.</p> <p align=""left"">For patients assessed as having extensive intestinal inflammation of the small intestines, such evidence of intestinal inflammation includes:</p><p align=""left"">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align=""left"">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align=""left"">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align=""left"">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.</p> <p align=""justify"">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.</p> <p align=""left"">If fewer than 3 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.</p> <p align=""left"">Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""left"">An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight with 3 repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","Y","2026-08-01","N","4708"
"19035_19035_R","Continuing treatment","STREAMLINED","19035","19035","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adult-type IDH-mutant astrocytoma or oligodendroglioma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adult-type IDH-mutant astrocytoma or oligodendroglioma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"19037_19037_R","Continuing treatment - Second-line therapy","AUTHORITY_REQUIRED","19037","19037","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Continuing treatment - Second-line therapy</p><br/><p>Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months of PBS and non-PBS-subsidised therapy with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Continuing treatment - Second-line therapy</p><br/><p>Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy; AND</p> <p>The treatment must not exceed a lifetime maximum of 18 months of PBS and non-PBS-subsidised therapy with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"19040_19045_R","Switching from PBS-subsidised migalastat","AUTHORITY_REQUIRED","19045","19040","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Switching from PBS-subsidised migalastat</p><br/><p>Patient must have received prior treatment with PBS-subsidised migalastat for this condition; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have failed to demonstrate clinical improvement or stabilisation of this condition with previous PBS-subsidised treatment with this drug; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient&apos;s medical records.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Switching from PBS-subsidised migalastat</p><br/><p>Patient must have received prior treatment with PBS-subsidised migalastat for this condition; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have failed to demonstrate clinical improvement or stabilisation of this condition with previous PBS-subsidised treatment with this drug; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).</p>","N","N","Y","IMMEDIATE","ALL","Y","2026-08-01","N","4708"
"19043_18972_R","Initial treatment - First-line therapy","AUTHORITY_REQUIRED","18972","19043","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Initial treatment - First-line therapy</p><br/><p>Patient must not have received PBS-subsidised treatment with any of: (i) anti-resorptive therapy, (ii) teriparatide, (iii) romosozumab, (iv) abaloparatide; or</p> <p>Patient must have developed intolerance to abaloparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy; AND</p> <p>Patient must be at very high risk of fracture; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must have had a symptomatic fracture due to minimal trauma; AND</p> <p>Patient must have had at least 1 hip or symptomatic vertebral fracture in the previous 24 months; or</p> <p>Patient must have had at least 2 fractures including 1 symptomatic new fracture in the previous 24 months; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND</p> <p>Must be treated by a consultant physician.</p> <p align=""justify"">Details of fracture history including the date(s), site(s), the symptoms associated with the fracture(s) and the score of the qualifying BMD measurement must be provided at the time of application.</p> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive therapies for osteoporosis include alendronate sodium, risedronate sodium, raloxifene hydrochloride, denosumab and zoledronic acid.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe established osteoporosis</p><br/><p>Initial treatment - First-line therapy</p><br/><p>Patient must not have received PBS-subsidised treatment with any of: (i) anti-resorptive therapy, (ii) teriparatide, (iii) romosozumab, (iv) abaloparatide; or</p> <p>Patient must have developed intolerance to abaloparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy; AND</p> <p>Patient must be at very high risk of fracture; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must have had a symptomatic fracture due to minimal trauma; AND</p> <p>Patient must have had at least 1 hip or symptomatic vertebral fracture in the previous 24 months; or</p> <p>Patient must have had at least 2 fractures including 1 symptomatic new fracture in the previous 24 months; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND</p> <p>Must be treated by a consultant physician.</p> <p align=""justify"">Details of fracture history including the date(s), site(s), the symptoms associated with the fracture(s) and the score of the qualifying BMD measurement must be provided at the time of application.</p> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive therapies for osteoporosis include alendronate sodium, risedronate sodium, raloxifene hydrochloride, denosumab and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"19044_19044_R","Switching from PBS-subsidised pegunigalsidase alfa","AUTHORITY_REQUIRED","19044","19044","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Switching from PBS-subsidised pegunigalsidase alfa</p><br/><p>Patient must have received prior treatment with PBS-subsidised pegunigalsidase alfa for this condition; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>Patient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant; AND</p> <p>Patient must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have failed to demonstrate clinical improvement or stabilisation of this condition with previous PBS-subsidised treatment with this drug; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fabry disease</p><br/><p>Switching from PBS-subsidised pegunigalsidase alfa</p><br/><p>Patient must have received prior treatment with PBS-subsidised pegunigalsidase alfa for this condition; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>Patient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant; AND</p> <p>Patient must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not have failed to demonstrate clinical improvement or stabilisation of this condition with previous PBS-subsidised treatment with this drug; AND</p> <p>Must be treated by a physician with expertise in the management of Fabry disease; AND</p> <p>Patient must be at least 12 years of age.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"19047_19048_R","null","STREAMLINED","19048","19047","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced or metastatic medullary thyroid cancer</p><br/><p>The condition must be unresectable with documented disease progression prior to commencing treatment with this drug; AND</p> <p>The condition must have evidence of activating RET variants in tumour material - this evidence has been obtained prior to commencing treatment with this drug; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be initiating treatment with this drug; or</p> <p>Patient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug.</p> <p align=""justify"">Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Medical practitioners may prescribe selpercatinib 80 mg with a quantity of up to 56 units where the dose does not exceed 120 mg twice daily (i.e., in combination with selpercatinib 40 mg). Selpercatinib 80 mg with a quantity of 112 units must be prescribed only where the dose is 160 mg twice daily to provide 28 days of treatment per dispensing. Prescribers should refer to the TGA PI for dosing and dose adjustments regimens.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced or metastatic medullary thyroid cancer</p><br/><p>The condition must be unresectable with documented disease progression prior to commencing treatment with this drug; AND</p> <p>The condition must have evidence of activating RET variants in tumour material - this evidence has been obtained prior to commencing treatment with this drug; AND</p> <p>Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND</p> <p>Patient must be initiating treatment with this drug; or</p> <p>Patient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug.</p> <p align=""justify"">Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Medical practitioners may prescribe selpercatinib 80 mg with a quantity of up to 56 units where the dose does not exceed 120 mg twice daily (i.e., in combination with selpercatinib 40 mg). Selpercatinib 80 mg with a quantity of 112 units must be prescribed only where the dose is 160 mg twice daily to provide 28 days of treatment per dispensing. Prescribers should refer to the TGA PI for dosing and dose adjustments regimens.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"19049_19055_R","Initial treatment","AUTHORITY_REQUIRED","19055","19049","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary tyrosinaemia type 1 (HT-1)</p><br/><p>Initial treatment</p><br/><p>Patient must have a confirmed diagnosis of HT-1 based on the presence of succinylacetone in either: (i) urine, (ii) blood; AND</p> <p>The treatment must be in combination with dietary restriction of tyrosine and phenylalanine; AND</p> <p>Patient must not be suffering from any other severe or life-threatening medical condition, including complications or sequelae of HT-1, that might compromise the effectiveness of treatment with this drug or where the long-term prognosis is unlikely to be altered by treatment with this drug; AND</p> <p>Must be treated by a physician with expertise in the management of HT-1; AND</p> <p>Must be treated in a centre with expertise in genetic metabolic disorders; AND</p> <p>Patient must be less than 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the blood and/or urine test results must be conducted no more than 12 months prior to the date of authority application and documented in the patient&apos;s medical records.</p><p align=""justify"">Prescribers must state the patient&apos;s body weight with every authority application, and document it in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary tyrosinaemia type 1 (HT-1)</p><br/><p>Initial treatment</p><br/><p>Patient must have a confirmed diagnosis of HT-1 based on the presence of succinylacetone in either: (i) urine, (ii) blood; AND</p> <p>The treatment must be in combination with dietary restriction of tyrosine and phenylalanine; AND</p> <p>Patient must not be suffering from any other severe or life-threatening medical condition, including complications or sequelae of HT-1, that might compromise the effectiveness of treatment with this drug or where the long-term prognosis is unlikely to be altered by treatment with this drug; AND</p> <p>Must be treated by a physician with expertise in the management of HT-1; AND</p> <p>Must be treated in a centre with expertise in genetic metabolic disorders; AND</p> <p>Patient must be less than 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the blood and/or urine test results must be conducted no more than 12 months prior to the date of authority application and documented in the patient&apos;s medical records.</p><p align=""justify"">Prescribers must state the patient&apos;s body weight with every authority application, and document it in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","IMMEDIATE","ALL","N","2026-08-01","Y","4708"
"19050_19057_R","Grandfather arrangement (transition from LSDP-funded Hereditary Tyrosinaemia type 1 therapy)","AUTHORITY_REQUIRED","19057","19050","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary tyrosinaemia type 1 (HT-1)</p><br/><p>Grandfather arrangement (transition from LSDP-funded Hereditary Tyrosinaemia type 1 therapy)</p><br/><p>Patient must have previously received treatment with this drug for this condition under the Australian Government''s Life Saving Drugs Program (LSDP) prior to 1 August 2026; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>The treatment must be in combination with dietary restriction of tyrosine and phenylalanine; AND</p> <p>Must be treated by a physician with expertise in the management of HT-1; AND</p> <p>Must be treated in a centre with expertise in genetic metabolic disorders.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the blood and/or urine test results at baseline, must be documented in the patient&apos;s medical records.<strike/></p><p align=""justify"">Prescribers must state the patient&apos;s body weight with every authority application, and document it in the patient&apos;s medical records.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary tyrosinaemia type 1 (HT-1)</p><br/><p>Grandfather arrangement (transition from LSDP-funded Hereditary Tyrosinaemia type 1 therapy)</p><br/><p>Patient must have previously received treatment with this drug for this condition under the Australian Government''s Life Saving Drugs Program (LSDP) prior to 1 August 2026; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>The treatment must be in combination with dietary restriction of tyrosine and phenylalanine; AND</p> <p>Must be treated by a physician with expertise in the management of HT-1; AND</p> <p>Must be treated in a centre with expertise in genetic metabolic disorders.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the blood and/or urine test results at baseline, must be documented in the patient&apos;s medical records.<strike/></p><p align=""justify"">Prescribers must state the patient&apos;s body weight with every authority application, and document it in the patient&apos;s medical records.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","IMMEDIATE","ALL","N","2026-08-01","Y","4708"
"19051_19058_R","Grandfather arrangement (transition from LSDP-funded Hereditary Tyrosinaemia type 1 therapy)","AUTHORITY_REQUIRED","19058","19051","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary tyrosinaemia type 1 (HT-1)</p><br/><p>Grandfather arrangement (transition from LSDP-funded Hereditary Tyrosinaemia type 1 therapy)</p><br/><p>Patient must have previously received treatment with this drug for this condition under the Australian Government''s Life Saving Drugs Program (LSDP) prior to 1 August 2026; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>The treatment must be in combination with dietary restriction of tyrosine and phenylalanine; AND</p> <p>Must be treated by a physician with expertise in the management of HT-1; AND</p> <p>Must be treated in a centre with expertise in genetic metabolic disorders; AND</p> <p>Patient must be less than 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the blood and/or urine test results at baseline, must be documented in the patient&apos;s medical records.<strike/></p><p align=""justify"">Prescribers must state the patient&apos;s body weight with every authority application, and document it in the patient&apos;s medical records.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary tyrosinaemia type 1 (HT-1)</p><br/><p>Grandfather arrangement (transition from LSDP-funded Hereditary Tyrosinaemia type 1 therapy)</p><br/><p>Patient must have previously received treatment with this drug for this condition under the Australian Government''s Life Saving Drugs Program (LSDP) prior to 1 August 2026; AND</p> <p>Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient''s record; AND</p> <p>Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug; AND</p> <p>The treatment must be in combination with dietary restriction of tyrosine and phenylalanine; AND</p> <p>Must be treated by a physician with expertise in the management of HT-1; AND</p> <p>Must be treated in a centre with expertise in genetic metabolic disorders; AND</p> <p>Patient must be less than 18 years of age.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the blood and/or urine test results at baseline, must be documented in the patient&apos;s medical records.<strike/></p><p align=""justify"">Prescribers must state the patient&apos;s body weight with every authority application, and document it in the patient&apos;s medical records.</p> <p align=""justify"">A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.</p> <p align=""justify"">This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","IMMEDIATE","ALL","N","2026-08-01","Y","4708"
"19054_19053_R","Initial treatment","AUTHORITY_REQUIRED","19053","19054","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary tyrosinaemia type 1 (HT-1)</p><br/><p>Initial treatment</p><br/><p>Patient must have a confirmed diagnosis of HT-1 based on the presence of succinylacetone in either: (i) urine, (ii) blood; AND</p> <p>The treatment must be in combination with dietary restriction of tyrosine and phenylalanine; AND</p> <p>Patient must not be suffering from any other severe or life-threatening medical condition, including complications or sequelae of HT-1, that might compromise the effectiveness of treatment with this drug or where the long-term prognosis is unlikely to be altered by treatment with this drug; AND</p> <p>Must be treated by a physician with expertise in the management of HT-1; AND</p> <p>Must be treated in a centre with expertise in genetic metabolic disorders.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the blood and/or urine test results must be conducted no more than 12 months prior to the date of authority application and documented in the patient&apos;s medical records.</p><p align=""justify"">Prescribers must state the patient&apos;s body weight with every authority application, and document it in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hereditary tyrosinaemia type 1 (HT-1)</p><br/><p>Initial treatment</p><br/><p>Patient must have a confirmed diagnosis of HT-1 based on the presence of succinylacetone in either: (i) urine, (ii) blood; AND</p> <p>The treatment must be in combination with dietary restriction of tyrosine and phenylalanine; AND</p> <p>Patient must not be suffering from any other severe or life-threatening medical condition, including complications or sequelae of HT-1, that might compromise the effectiveness of treatment with this drug or where the long-term prognosis is unlikely to be altered by treatment with this drug; AND</p> <p>Must be treated by a physician with expertise in the management of HT-1; AND</p> <p>Must be treated in a centre with expertise in genetic metabolic disorders.</p> <p align=""justify"">The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.</p> <p align=""justify"">If the application is submitted through HPOS form upload or mail, it must include:</p><p align=""justify"">(i) details of the proposed prescription; and</p><p align=""justify"">(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align=""justify"">At the time of authority application, the prescriber must request the appropriate quantity units of appropriate strength(s), based on the weight of the patient, to provide sufficient drug for up to 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI). Up to 5 repeats will be authorised to provide for a total of 24 weeks of treatment.</p><p align=""justify"">A separate authority prescription form must be completed for each strength requested.</p> <p align=""justify"">Confirmation of eligibility for treatment with diagnostic reports including the blood and/or urine test results must be conducted no more than 12 months prior to the date of authority application and documented in the patient&apos;s medical records.</p><p align=""justify"">Prescribers must state the patient&apos;s body weight with every authority application, and document it in the patient&apos;s medical records.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","IMMEDIATE","ALL","N","2026-08-01","Y","4708"
"19056_19052_R","Induction treatment","AUTHORITY_REQUIRED","19052","19056","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Induction treatment</p><br/><p>The condition must have relapsed, or be refractory to, at least two prior systemic therapies; AND</p> <p>Patient must have a WHO performance status of no higher than 2; AND</p> <p>Patient must have previously received treatment with chimeric antigen receptor-T (CAR-T) cell therapy for this condition; or</p> <p>Patient must be currently unable to receive treatment with CAR-T cell therapy for this condition; AND</p> <p>Patient must not be eligible for stem cell transplantation; AND</p> <p>Patient must not have received prior treatment with a PBS-subsidised CD20xCD3 bispecific monoclonal antibody (unless this is for a re-priming cycle with epcoritamab due to missed or delayed dose); AND</p> <p>The treatment must be discontinued in patients who experience disease progression whilst on treatment.</p> <p align=""justify"">Prior systemic therapy may include autologous stem cell transplant.</p> <p align=""justify"">Definition of patients unable to receive treatment with CAR-T cell therapy for this condition include geographical, psychosocial, clinical ineligibility or urgency.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)</p><br/><p>Induction treatment</p><br/><p>The condition must have relapsed, or be refractory to, at least two prior systemic therapies; AND</p> <p>Patient must have a WHO performance status of no higher than 2; AND</p> <p>Patient must have previously received treatment with chimeric antigen receptor-T (CAR-T) cell therapy for this condition; or</p> <p>Patient must be currently unable to receive treatment with CAR-T cell therapy for this condition; AND</p> <p>Patient must not be eligible for stem cell transplantation; AND</p> <p>Patient must not have received prior treatment with a PBS-subsidised CD20xCD3 bispecific monoclonal antibody (unless this is for a re-priming cycle with epcoritamab due to missed or delayed dose); AND</p> <p>The treatment must be discontinued in patients who experience disease progression whilst on treatment.</p> <p align=""justify"">Prior systemic therapy may include autologous stem cell transplant.</p> <p align=""justify"">Definition of patients unable to receive treatment with CAR-T cell therapy for this condition include geographical, psychosocial, clinical ineligibility or urgency.</p> <p align=""justify"">A dose of 0.16 mg to be administered on Day 1 with initial 4 mg vial. A dose of 0.8 mg to be administered on Day 8 with the repeat 4 mg vial. Refer to the epcoritamab Therapeutic Goods Administration (TGA) approved Product Information.</p>","N","N","N","IMMEDIATE","ALL","N","2026-08-01","N","4708"
"19191_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form imatinib tablet 100 mg and imatinib capsule 100 mg are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2016-11-01","N","4708"
"19258_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form imatinib tablet 400 mg and imatinib capsule 400 mg are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2016-11-01","N","4708"
"19273_N","null","null","null","null","null","<p align=""justify"">Allogeneic stem cell transplantation is the preferred therapy for eligible patients achieving a complete remission of Philadelphia positive acute lymphoblastic leukaemia.</p>","Y","N","N","null","null","N","2016-11-01","N","4708"
"19403_N","null","null","null","null","null","<p align=""justify"">Patient dosage is to be determined as per the dose transition table in the Product Information based on the maintenance dose of paliperidone once monthly injection.</p>","Y","N","N","null","null","N","2017-04-01","N","4708"
"19700_C","null","null","null","null","null","<p align=""justify"">This is a category X drug and must not be given to pregnant women. Pregnancy must be avoided during treatment and for at least 1 month following cessation of therapy, as recommended by the TGA-approved Product Information.</p>","N","Y","N","null","null","N","2017-01-01","N","4708"
"19808_N","null","null","null","null","null","<p align=""justify"">WARNING: Eculizumab increases the risk of meningococcal infections (septicaemia and/or meningitis).</p><p align=""justify"">Please consult the approved PI for information about vaccination against meningococcal infection.</p>","Y","N","N","null","null","N","2017-01-01","N","4708"
"19809_N","null","null","null","null","null","<p align=""justify"">For copies of the ACQ, please contact GlaxoSmithKline Medical Information on 1800 033 109.</p>","Y","N","N","null","null","N","2017-01-01","N","4708"
"19891_N","null","null","null","null","null","<p align=""justify"">For copies of the ACQ and the calculation sheets please contact Novartis Medical Information on 1800 671 203 or medinfo.phauno@novartis.com</p>","Y","N","N","null","null","N","2017-01-01","N","4708"
"19967_C","null","null","null","null","null","<p align=""justify"">This drug is a category X drug and must not be given to pregnant women. If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans cannot be ruled out.</p>","N","Y","N","null","null","N","2017-02-01","N","4708"
"20354_C","null","null","null","null","null","<p align=""justify"">Vismodegib is a category X drug and must not be given to pregnant women. Pregnancy in female patients or in the partners of male patients must be avoided during treatment and during the 24 months and 2 months period after cessation of treatment for female and male patients respectively, as according to the TGA approved Product Information.</p>","N","Y","N","null","null","N","2017-04-01","N","4708"
"20383_N","null","null","null","null","null","<p align=""justify"">A patient who has had progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.</p>","Y","N","N","null","null","N","2017-04-01","N","4708"
"20473_N","null","null","null","null","null","<p align=""justify"">A complete remission is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a full recovery of peripheral blood counts with platelets of greater than 100,000 per microliter, and absolute neutrophil count (ANC) of greater than 1,000 per microliter.</p>","Y","N","N","null","null","N","2017-05-01","N","4708"
"20549_C","null","null","null","null","null","<p align=""justify"">Careful monitoring of patients is required due to risk of developing life-threatening Cytokine Release Syndrome, neurological toxicities and reactivation of John Cunningham virus (JC) viral infection.</p>","N","Y","N","null","null","N","2017-05-01","N","4708"
"20652_N","null","null","null","null","null","<p align=""justify"">Applications for treatment with this drug where the dosing frequency exceeds 40 mg per fortnight will not be approved.</p>","Y","N","N","null","null","N","2017-06-01","N","4708"
"20735_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form baclofen 10 mg/5 mL intrathecal injection, 5 mL ampoule and pharmaceutical benefits that have the form baclofen 10 mg/5 mL intrathecal injection, 10 x 5 mL ampoules are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2017-06-01","N","4708"
"20811_C","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits containing gemcitabine may have different concentrations.</p>","N","Y","N","null","null","N","2017-06-01","N","4708"
"20995_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms tenofovir disoproxil phosphate 291 mg tablet, tenofovir disoproxil maleate 300 mg tablet, and tenofovir disoproxil fumarate 300 mg tablet are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2017-08-01","N","4708"
"21169_N","null","null","null","null","null","<p align=""justify"">Increase in the maximum number of repeats of up to 2 may be authorised in patients whose dosing frequency is every 8 weeks.</p>","Y","N","N","null","null","N","2017-09-01","N","4708"
"21279_C","null","null","null","null","null","<p align=""justify"">Sonidegib is a category X drug and must not be given to pregnant women. Pregnancy in female patients or in the partners of male patients must be avoided during treatment and during the 20 months and 6 months period after cessation of treatment for female and male patients respectively, as according to the TGA approved Product Information.</p>","N","Y","N","null","null","N","2018-04-01","N","4708"
"21334_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form darunavir tablet 800 mg and pharmaceutical benefits that have the form darunavir tablet 800 mg (as ethanolate) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2017-12-01","N","4708"
"21501_N","null","null","null","null","null","<p align=""justify"">No increase in the maximum amount or number of units may be authorised.</p>","Y","N","N","null","null","N","2018-01-01","N","4708"
"21822_N","null","null","null","null","null","<p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p>","Y","N","N","null","null","N","2018-04-01","N","4708"
"21824_N","null","null","null","null","null","<p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p>","Y","N","N","null","null","N","2018-04-01","N","4708"
"21825_N","null","null","null","null","null","<p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","Y","N","N","null","null","N","2018-04-01","N","4708"
"21971_N","null","null","null","null","null","<p align=""justify"">The in-use shelf life of Novatears is 6 months from the date of opening.</p>","Y","N","N","null","null","N","2018-09-01","N","4708"
"21974_N","null","null","null","null","null","<p align=""justify"">Formal assessment and correction of inhaler technique should be performed in accordance with the COPD-X Plan (available at http://copdx.org.au/); the assessment and adherence to correct technique should be documented in the patient&apos;s medical records.</p>","Y","N","N","null","null","N","2018-06-01","N","4708"
"21976_N","null","null","null","null","null","<p align=""justify"">The treatment must not be used in combination with an ICS/LABA, LABA/LAMA or LAMA, LABA or ICS monotherapy.</p>","Y","N","N","null","null","N","2018-06-01","N","4708"
"21977_N","null","null","null","null","null","<p align=""justify"">An ICS includes fluticasone propionate, fluticasone furoate, budesonide, beclometasone or ciclesonide.</p>","Y","N","N","null","null","N","2018-06-01","N","4708"
"22191_N","null","null","null","null","null","<p align=""justify"">If the wound has not healed during this period, further use is to be discontinued after initial pack, no repeats. Where wounds remain unresponsive to standard treatment, patient should be referred on to a specialist.</p>","Y","N","N","null","null","N","2018-07-01","N","4708"
"22202_C","null","null","null","null","null","<p align=""justify"">QT interval monitoring is required for patients treated with this drug.</p>","N","Y","N","null","null","N","2018-07-01","N","4708"
"22301_N","null","null","null","null","null","<p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p>","Y","N","N","null","null","N","2018-08-01","N","4708"
"22302_N","null","null","null","null","null","<p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p>","Y","N","N","null","null","N","2018-08-01","N","4708"
"22404_N","null","null","null","null","null","<p align=""justify"">Authority applications for increased repeats up to a maximum of 5 may be authorised for patients requiring dose optimisation for this condition not adequately provided by other strengths of this drug.</p>","Y","N","N","null","null","N","2018-09-01","N","4708"
"22470_N","null","null","null","null","null","<p align=""justify"">Not for use in vulvovaginal candida infections.</p>","Y","N","N","null","null","N","2018-09-01","N","4708"
"22509_C","null","null","null","null","null","<p align=""justify"">Tolvaptan has been associated with idiosyncratic hepatic toxicity. Liver function monitoring is required.</p>","N","Y","N","null","null","N","2019-01-01","N","4708"
"22551_N","null","null","null","null","null","<p align=""justify"">An acute event may be a clinical or external event that leads to upper motor neuron lesions resulting in spasticity for example stroke, traumatic brain injury, spinal cord injury, infection or hypoxia.</p>","Y","N","N","null","null","N","2019-09-01","N","4708"
"22579_N","null","null","null","null","null","<p align=""justify"">For copies of the ACQ, please contact AstraZeneca Medical Information on 1800 805 342.</p>","Y","N","N","null","null","N","2018-12-01","N","4708"
"22705_N","null","null","null","null","null","<p align=""justify"">Patient must be aged 18 years or older.</p>","Y","N","N","null","null","N","2018-10-01","N","4708"
"22706_N","null","null","null","null","null","<p align=""justify"">Patient must be aged 12 years or over.</p>","Y","N","N","null","null","N","2018-10-01","N","4708"
"23025_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have form pack size clonazepam 500 microgram tablet, 100 and clonazepam 500 microgram tablet, 50 are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2018-12-01","N","4708"
"23291_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have form pack size isotretinoin 20 mg capsule, 60 and isotretinoin 20 mg capsule, 30 are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2019-01-01","N","4708"
"23717_N","null","null","null","null","null","<p align=""justify"">Check patient adherence to lower dose proton pump inhibitor before &quot;stepping-up&quot; therapy.</p>","Y","N","N","null","null","N","2019-05-01","N","4708"
"23718_N","null","null","null","null","null","<p align=""justify"">Standard dose proton pump inhibitors are appropriate step-down therapy from high dose proton pump inhibitors.</p>","Y","N","N","null","null","N","2019-05-01","N","4708"
"23729_N","null","null","null","null","null","<p align=""justify"">Low dose proton pump inhibitors are appropriate step-down therapy from standard dose proton pump inhibitors.</p>","Y","N","N","null","null","N","2019-05-01","N","4708"
"23730_N","null","null","null","null","null","<p align=""justify"">A low dose proton pump inhibitor includes: lansoprazole 15mg, omeprazole 10mg, pantoprazole 20mg and rabeprazole 10mg.</p>","Y","N","N","null","null","N","2019-05-01","N","4708"
"23761_N","null","null","null","null","null","<p align=""justify"">This drug is not PBS-subsidised when used in combination with PBS-subsidised dexamfetamine sulfate or modafinil.</p>","Y","N","N","null","null","N","2019-04-01","N","4708"
"23767_N","null","null","null","null","null","<p align=""justify"">This drug is not PBS-subsidised when used in combination with PBS-subsidised dexamfetamine sulfate or armodafinil.</p>","Y","N","N","null","null","N","2019-04-01","N","4708"
"23865_N","null","null","null","null","null","<p align=""justify"">Treatment should be initiated by a specialist knowledgeable in the use of potent opioids for the management of chronic breathlessness.</p>","Y","N","N","null","null","N","2019-09-01","N","4708"
"23866_N","null","null","null","null","null","<p align=""justify"">Applications for an increased maximum quantity to provide for 1 month&apos;s supply of this drug will be authorised.</p>","Y","N","N","null","null","N","2019-09-01","N","4708"
"23951_N","null","null","null","null","null","<p align=""justify"">Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib or ponatinib at any one time and must not be receiving concomitant interferon alfa therapy.</p>","Y","N","N","null","null","N","2019-05-01","N","4708"
"23973_N","null","null","null","null","null","<p align=""justify"">Authority applications for increased quantities/ repeats (where relevant) may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","Y","N","Y","null","null","N","2019-05-01","N","4708"
"24113_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form apomorphine injection 30 mg/3 mL pen device and pharmaceutical benefits that have the form apomorphine injection 30 mg/3 mL cartridge are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2019-06-01","N","4708"
"24133_N","null","null","null","null","null","<p align=""justify"">The listing is intended to provide treatment for syphilis in Aboriginal and Torres Strait Islander patients in non-remote areas.</p>","Y","N","N","null","null","N","2019-09-01","N","4708"
"24186_C","null","null","null","null","null","<p align=""justify"">Morphine sulfate pentahydrate 10 and 20 mg modified release capsules must not be co-prescribed with immediate release oral morphine, when it has been prescribed for the reduction of chronic breathlessness.</p>","N","Y","N","null","null","N","2019-09-01","N","4708"
"24211_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form tiotropium 18 microgram powder for inhalation and pharmaceutical benefits that have the form tiotropium 13 microgram powder for inhalation are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2020-02-01","N","4708"
"24626_N","null","null","null","null","null","<p align=""justify"">Increased maximum quantity will be authorised where a patient&apos;s weight is greater than 125 kg.</p>","Y","N","N","null","null","N","2019-10-01","N","4708"
"24661_N","null","null","null","null","null","<p align=""justify"">Increased maximum quantity will be authorised where a patient requires a new loading dose due to a break in therapy of more than 1 week but less than 6 weeks from the last dose or a patient&apos;s weight is greater than 125 kg.</p>","Y","N","N","null","null","N","2019-10-01","N","4708"
"24951_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms sevelamer hydrochloride 800 mg and sevelamer carbonate 800 mg tablet are equivalent for the purposes of substitution</p>","Y","N","N","null","null","N","2019-12-01","N","4708"
"24978_N","null","null","null","null","null","<p align=""justify"">This product does not contain any vitamins, minerals or trace elements and is not intended as a sole source of nutrition</p>","Y","N","N","null","null","N","2019-12-01","N","4708"
"25071_N","null","null","null","null","null","<p align=""justify"">Patient should be treated with the recommended dose of pembrolizumab according to the TGA-approved Product Information.</p>","Y","N","N","null","null","N","2019-12-01","N","4708"
"25574_N","null","null","null","null","null","<p align=""justify"">Real time online applications for increased maximum quantities/repeats may be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/organisations/health-professionals/services/medicare/hpos/services/request-authority-using-online-pbs-authorities-hpos).</p><p align=""justify"">Phone applications for increased maximum quantities/repeats may be made by calling 1800 888 333.</p><p align=""justify"">Written authority applications for increased maximum quantities/repeats can be uploaded online through HPOS form upload or mailed to:</p><p align=""justify"">Pharmaceutical Benefits Scheme</p><p align=""justify"">Reply Paid 9857</p><p align=""justify"">[Your capital city]</p>","Y","N","N","null","null","N","2020-06-01","N","4708"
"25598_N","null","null","null","null","null","<p align=""justify"">Consider consultation with a multidisciplinary pain service prior to, or after commencement of this medication.</p>","Y","N","N","null","null","N","2020-06-01","N","4708"
"25651_N","null","null","null","null","null","<p align=""justify"">This treatment is not suitable for &apos;as-required&apos; pain relief.</p>","Y","N","N","null","null","N","2020-06-01","N","4708"
"25698_N","null","null","null","null","null","<p align=""justify"">This treatment is not recommended for use in ambulant patients.</p>","Y","N","N","null","null","N","2020-06-01","N","4708"
"25744_N","null","null","null","null","null","<p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","Y","N","Y","null","null","N","2020-04-01","N","4708"
"25745_N","null","null","null","null","null","<p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","Y","N","Y","null","null","N","2020-04-01","N","4708"
"25746_C","null","null","null","null","null","<p align=""justify"">Careful monitoring of patients is required due to risk of developing pulmonary adverse events observed in patients within the first seven days of treatment with this drug. Patients must be instructed to report any new or worsening respiratory symptoms.</p>","N","Y","N","null","null","N","2020-05-01","N","4708"
"25796_N","null","null","null","null","null","<p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 888 333.</p>","Y","N","N","null","null","N","2020-05-01","N","4708"
"26165_C","null","null","null","null","null","<p align=""justify"">Inadvertent muscular injection in patients aged less than 12 years may occur with the pen device.</p>","N","Y","N","null","null","N","2020-08-01","N","4708"
"26291_C","null","null","null","null","null","<p align=""justify"">This drug is a potent teratogen - pregnancy should be avoided during therapy and for at least three years after cessation of therapy.</p>","N","Y","N","null","null","N","2020-09-01","N","4708"
"26292_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form imipramine hydrochloride 25 mg tablet in a pack size of 50 can be substituted for a pack size of 100 in the case of a shortage.</p>","Y","N","N","null","null","N","2020-09-01","N","4708"
"26357_N","null","null","null","null","null","<p align=""justify"">No increase in the maximum quantity or number of units may be authorised for applications for treatment of one eye.</p>","Y","N","N","null","null","N","2020-10-01","N","4708"
"26437_C","null","null","null","null","null","<p align=""justify"">The safety of atezolizumab in combination with bevacizumab has not been established in patients who have incompletely treated varices, variceal bleeding within the previous 6 months or who are at high risk of bleeding. Patients should be assessed for risk of variceal bleeding prior to treatment with this combination.</p>","N","Y","N","null","null","N","2020-11-01","N","4708"
"26443_N","null","null","null","null","null","<p align=""justify"">Increased repeats of up to 11 may be requested for doses of 840 mg administered every 2 weeks</p>","Y","N","N","null","null","N","2020-11-01","N","4708"
"26476_C","null","null","null","null","null","<p align=""justify"">This drug is for ex vivo administration and must not to be injected directly into the patient.</p>","N","Y","N","null","null","N","2020-11-01","N","4708"
"26477_N","null","null","null","null","null","<p align=""justify"">The maximum quantity and maximum number of repeats are based on the following treatment protocol: one day of treatment per week for six weeks, then every two weeks for 12 weeks, then monthly thereafter. This differs from the Product Information. Requests for increased maximum quantities/maximum repeats will not be considered.</p>","Y","N","N","null","null","N","2020-11-01","N","4708"
"26492_N","null","null","null","null","null","<p align=""justify"">Treatment may be continued by a non-specialist prescriber without need for consultation with a specialist.</p>","Y","N","N","null","null","N","2020-11-01","N","4708"
"26570_N","null","null","null","null","null","<p align=""justify"">This product is not PBS-subsidised for use as &apos;maintenance and reliever&apos; therapy.</p>","Y","N","N","null","null","N","2020-12-01","N","4708"
"26571_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms mebendazole 100 mg tablet and mebendazole 100 mg chewable tablet are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2020-12-01","N","4708"
"26572_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the following forms are equivalent for the purposes of substitution: </p><ul><li>sodium bicarbonate 1.76 g + sodium citrate 630 mg + citric acid 720 mg + tartaric acid 890 mg powder for oral liquid; and</li><li>sodium bicarbonate 1.76 g + citric acid 720 mg + sodium citrate 630 mg + tartaric acid 890 mg effervescent granules.</li></ul>","Y","N","N","null","null","N","2020-12-01","N","4708"
"26576_N","null","null","null","null","null","<p align=""justify"">An outcome on the authority application is not immediate, but will follow in due course. Electronic upload is encouraged to reduce processing time.</p>","Y","N","N","null","null","N","2020-12-01","N","4708"
"26584_N","null","null","null","null","null","<p align=""justify"">This product is not PBS-subsidised for use as &apos;anti-inflammatory reliever&apos; therapy for mild asthma.</p>","Y","N","N","null","null","N","2020-12-01","N","4708"
"26589_N","null","null","null","null","null","<p align=""left"">Obinutuzumab is not to be used as monotherapy or in combination with anti-cancer drugs other than chlorambucil under this restriction. For use with venetoclax, refer to the separate listing for this purpose.</p>","Y","N","N","null","null","N","2020-12-01","N","4708"
"26624_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form norethisterone 1 mg + ethinylestradiol 35 microgram tablet in a 4 pack of 28 tablets can be substituted for a 3 pack of 28 tablets in the case of a shortage.</p>","Y","N","N","null","null","N","2020-12-01","N","4708"
"26672_N","null","null","null","null","null","<p align=""justify"">This drug is not PBS-subsidised for use in patients with multiple myeloma who have received two or more prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent, or, who are refractory to both a PI and an immunomodulatory agent, as monotherapy.</p>","Y","N","N","null","null","N","2021-01-01","N","4708"
"26710_N","null","null","null","null","null","<p align=""justify"">Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as &apos;combination therapy&apos;.</p>","Y","N","N","null","null","N","2021-02-01","N","4708"
"26832_N","null","null","null","null","null","<p align=""justify"">The treatment must not be prescribed under this restriction for any of the following PBS-indications: (i) gastro-oesophageal reflux disease (where the word &apos;complex&apos; is absent), (ii) scleroderma oesophagus, (iii) pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion, (iv) peptic ulcer, (v) eradication of <i>Helicobacter pylori.</i></p>","Y","N","N","null","null","N","2021-03-01","N","4708"
"26833_N","null","null","null","null","null","<p align=""justify"">A standard dose proton pump inhibitor is one of: esomeprazole 20 mg, lansoprazole 30 mg, omeprazole 20 mg, pantoprazole 40 mg, rabeprazole 20 mg.</p>","Y","N","N","null","null","N","2021-03-01","N","4708"
"26856_N","null","null","null","null","null","<p align=""justify"">The initiation pack is intended for use at the commencement of treatment and for re-initiation of therapy following treatment interruption. The first prescription for the 920 microgram capsules should occur under the Initial treatment restriction. Subsequent prescriptions should then occur under the Continuing treatment restriction. If treatment interruption of more than 14 consecutive days occurs for reasons other than lack of efficacy, apply under the Continuing treatment restriction for each of the Initiation pack and 920 microgram capsules. If treatment interruption occurs within the first 14 days, or, for more than 7 consecutive doses between treatment Days 15 to 28, re-apply for an initiation pack under the &apos;Initial treatment&apos; treatment phase.</p>","Y","N","N","null","null","N","2021-03-01","N","4708"
"26898_N","null","null","null","null","null","<p align=""justify"">A high dose proton pump inhibitor is: esomeprazole 40 mg.</p>","Y","N","N","null","null","N","2021-03-01","N","4708"
"26912_N","null","null","null","null","null","<p align=""justify"">Instructions on the use of the Eczema Area and Severity Index and copyright details can be found here:</p><p align=""justify"">https://www.dupixent.co.uk/-/media/EMS/Conditions/Dermatology/Brands/Dupixent-UK/global/1051-EASI-Leaflet-v6-webready.pdf</p>","Y","N","N","null","null","N","2021-03-01","N","4708"
"26913_N","null","null","null","null","null","<p align=""justify"">Instructions on the use of the Dermatology Life Quality Index and copyright details can be found here:</p><p align=""justify"">https://www.cardiff.ac.uk/medicine/resources/quality-of-life-questionnaires/dermatology-life-quality-index</p>","Y","N","N","null","null","N","2021-03-01","N","4708"
"26994_N","null","null","null","null","null","<p align=""justify"">For copies of the ACQ and the calculation sheets please contact Sanofi Medical Information on 1800 818 806 or MedInfo.Australia@sanofi.com</p>","Y","N","N","null","null","N","2021-04-01","N","4708"
"27030_N","null","null","null","null","null","<p align=""justify"">Formal assessment and correction of inhaler technique should be performed in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique (available at www.nationalasthma.org.au); the assessment and adherence to correct technique should be documented in the patient&apos;s medical records. Patients can obtain support with inhaler technique through their local Asthma Foundation (1800 645 130).</p>","Y","N","N","null","null","N","2021-04-01","N","4708"
"27047_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form adalimumab 20 mg/0.2 mL syringes and pharmaceutical benefits that have the form adalimumab 20 mg/0.4 mL syringes are equivalent for the purposes of substitution</p>","Y","N","N","null","null","N","2021-04-01","N","4708"
"27048_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form adalimumab 40 mg/0.4 mL pen devices and pharmaceutical benefits that have the form adalimumab 40 mg/0.8 mL pen devices are equivalent for the purposes of substitution</p>","Y","N","N","null","null","N","2021-04-01","N","4708"
"27049_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form adalimumab 40 mg/0.4 mL syringes and pharmaceutical benefits that have the form adalimumab 40 mg/0.8 mL syringes are equivalent for the purposes of substitution</p>","Y","N","N","null","null","N","2021-04-01","N","4708"
"27130_N","null","null","null","null","null","<p align=""justify""><b>Prescribing the 80 mg presentation:</b></p><p align=""justify"">Two completed authority prescriptions may be submitted with every initial application for this biological medicine. One prescription for an induction dose of 80 mg and no repeats and the second prescription for 2 doses of 40 mg and 3 repeats.</p>","Y","N","N","null","null","N","2021-04-01","N","4708"
"27134_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have a pack size of 1 may be substituted for pharmaceutical benefits that have a pack size of 2, in combinations equivalent to the maximum quantity number of units.</p>","Y","N","N","null","null","N","2021-04-01","N","4708"
"27162_N","null","null","null","null","null","<p align=""justify"">Authorisation for an increased maximum quantity, up to double the stated &apos;Max qty packs&apos; value, may be sought.</p>","Y","N","N","null","null","N","2021-05-01","N","4708"
"27176_N","null","null","null","null","null","<p align=""justify"">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p>","Y","N","N","null","null","N","2021-06-01","N","4708"
"27179_N","null","null","null","null","null","<p align=""justify"">Requests for increased quantities may be sought based on daily doses not exceeding 20 mg/kg/day (in line with the Product Information) for up to 4 weeks per dispensing.</p>","Y","N","N","null","null","N","2021-05-01","N","4708"
"27199_N","null","null","null","null","null","<p align=""justify"">Real time online applications for increased maximum quantities/repeats may be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/organisations/health-professionals/services/medicare/hpos/services/request-authority-using-online-pbs-authorities-hpos).</p><p align=""justify"">Written authority applications for increased maximum quantities/repeats can be uploaded online through HPOS form upload or mailed to:</p><p align=""justify"">Pharmaceutical Benefits Scheme</p><p align=""justify"">Reply Paid 9857</p><p align=""justify"">[Your capital city]</p>","Y","N","N","null","null","N","2021-06-01","N","4708"
"27235_N","null","null","null","null","null","<p align=""justify"">Request an appropriate maximum quantity based on testing response to treatment for 7 days, with the number of packs being a whole number, based on dosing no greater than 20 mg/kg per day. Combinations of the sachets and tablets are permitted to reduce high tablet burden.</p>","Y","N","N","null","null","N","2021-07-01","N","4708"
"27279_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF PAEDIATRIC PATIENTS WITH REFRACTORY CROHN DISEASE </b></p><p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) for paediatric patients with adalimumab for severe refractory Crohn disease and infliximab for moderate to severe refractory Crohn disease. Where the term &quot;biological medicines&quot; appears in the following notes and restrictions, it refers to adalimumab and infliximab only.</p><p align=""justify"">A patient is eligible for PBS-subsidised treatment with only one PBS-subsidised biological medicine at any one time.</p><p align=""justify"">From 1 August 2015, under the PBS, patients will be able to commence a treatment cycle where they may trial a PBS-subsidised biological medicine without having to experience a disease flare when swapping to the alternate agent. Under these arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with a biological medicine while they continue to show a response to therapy.</p><p align=""justify"">A patient who received PBS-subsidised biological medicine treatment prior to 1 August 2015 is considered to have started their treatment cycle as of 1 August 2015.</p><p align=""justify"">Within the same treatment cycle, a paediatric patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than twice.</p><p align=""justify"">Once a patient has either failed, or ceased to respond to treatment for this condition 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy for this condition before they are eligible to commence the next cycle. The 5-year break is measured from the date of the last approval for PBS-subsidised biological medicine treatment in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">A patient who has failed fewer than 3 trials of biological medicine therapy in a treatment cycle and who has a break in therapy of less than 5 years may commence a further course of treatment within the same treatment cycle.</p><p align=""justify"">A patient who has failed 3 trials or fewer of biological medicine therapy in a treatment cycle and who has a break in therapy of more than 5 years may commence a new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""justify"">How to prescribe PBS-subsidised biological medicine therapy after 1 August 2015.</p><p align=""justify"">(1) Initial treatment.</p><p align=""justify"">Applications for initial treatment should be made where:</p><p align=""justify"">(i) a patient has received no prior PBS-subsidised biological medicine therapy in this treatment cycle and wishes to commence such therapy - Initial 1 (new patient); or</p><p align=""justify"">(ii) a patient has received prior PBS-subsidised (initial or continuing) biological medicine therapy and wishes to trial an alternate agent - Initial 2 (Change or Re-commencement of treatment after a break in therapy of less than 5 years ) [further details are under &apos;Swapping therapy&apos; below]; or</p><p align=""justify"">(iii) a patient wishes to re-commence treatment with a specific biological medicine following a break in PBS-subsidised therapy with that agent - Initial 2 (Change or Re-commencement of treatment after a break in therapy of less than 5 years ); or</p><p align=""justify"">(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years).</p><p align=""justify"">Initial treatment authorisations will be limited to provide for a maximum of 16 weeks of therapy for adalimumab and 14 weeks of therapy for infliximab.</p><p align=""justify"">From 1 August 2015, a patient must be assessed for response to any course of initial PBS-subsidised biological therapy following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab, and this assessment must be conducted no later than 4 weeks from the date that course was ceased.</p><p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p><p align=""justify"">(2) Continuing treatment.</p><p align=""justify"">Following the completion of an initial treatment course with a specific biological medicine, a patient remains eligible to receive up to 24 weeks per course of continuing treatment under the First continuing treatment and Subsequent continuing treatment restrictions with that drug providing they continue to sustain the response.</p><p align=""justify"">It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.</p><p align=""justify"">(3) Swapping therapy.</p><p align=""justify"">Once initial treatment with the first PBS-subsidised biological medicine therapy is approved, a patient with severe disease may swap if eligible to the alternate biological medicine within the same treatment cycle without having to requalify with respect to the indices of disease severity (i.e. Paediatric Crohn Disease Activity Index (PCDAI) Score, confirmation of Crohn disease), or the prior conventional therapies of corticosteroid therapy, immunosuppressive therapy or enteral nutrition.</p><p align=""justify"">A patient cannot swap to a biological medicine if they have failed to respond to prior treatment with that drug twice within the same treatment cycle.</p><p align=""justify"">To ensure a patient receives the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment within the timeframes specified in the relevant restriction.</p><p align=""justify"">A patient who is not able to complete an initial treatment course for a biological medicine will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p><p align=""justify"">(4) Baseline measurements to determine response.</p><p align=""justify"">A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements submitted with the first authority application for a biological medicine. However, prescribers may provide new baseline measurements any time that an initial treatment authority application is submitted within a treatment cycle and eligibility for continuing treatment must be assessed according to these revised baseline measurements.</p><p align=""justify"">(5) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.</p><p align=""justify"">A patient who wishes to recommence treatment following a break in PBS-subsidised biological medicine therapy of at least 5 years, must requalify for initial treatment with respect to the indices of disease severity under the Initial 3 restriction. A retrial of conventional therapies is not required.</p>","Y","N","N","null","null","N","2021-06-01","N","4708"
"27335_N","null","null","null","null","null","<p align=""justify"">The application should indicate which formulation eg. pre-filled pen or pre-filled syringe to ensure appropriate item is approved.</p>","Y","N","N","null","null","N","2021-07-01","N","4708"
"27391_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF PAEDIATRIC PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS</b></p><p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) for paediatric patients with infliximab or adalimumab for moderate to severe ulcerative colitis; and infliximab for acute severe ulcerative colitis. Where the term &apos;biological medicine&apos; appears in the following notes and restrictions, it refers to infliximab and adalimumab only.</p><p align=""justify"">A patient is eligible for PBS-subsidised treatment with only 1 of the 2 biological medicines at any one time.</p><p align=""justify"">From 1 June 2017, under the PBS, all paediatric patients will be able to commence a treatment cycle where they may trial each PBS-subsidised biological medicine without having to experience a disease flare when swapping to the alternate agent. Under these arrangements, within a single treatment cycle and depending on the disease severity, a patient may continue to receive long-term treatment with a biological medicine while they continue to show a response to therapy. A patient who received PBS-subsidised biological medicine treatment prior to 1 June 2017 is considered to have started their treatment cycle as of 1 June 2017. Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than twice. Once a patient has either failed or ceased to respond to treatment 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy before they are eligible to commence the next cycle. The 5-year break is measured from the date of the last approval for PBS-subsidised biological medicine treatment in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven&apos;s Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.</p><p align=""justify"">A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of less than 5 years may commence a further course of treatment within the same treatment cycle under the Initial 2 treatment restriction.</p><p align=""justify"">A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of more than 5 years may commence a new treatment cycle under the Initial 3 treatment restriction.</p><p align=""justify"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""justify"">How to prescribe PBS-subsidised biological medicine therapy after 1 June 2017.</p><p align=""justify"">(1) Initial treatment.</p><p align=""justify"">Applications for initial treatment should be made where:</p><p align=""justify"">(i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy - Initial 1 treatment (new patient); or,</p><p align=""justify"">(ii) a patient has received prior PBS-subsidised biological medicine therapy (initial or continuing) and wishes to trial an alternate agent - Initial 2 treatment (Change or Recommencement of treatment after a break in biological medicine therapy of less than 5 years ) [further details are under &apos;Swapping treatment&apos; below]; or</p><p align=""justify"">(iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy with the same agent - Initial 2 treatment (Change or Recommencement of treatment after a break in therapy of less than 5 years ); or</p><p align=""justify"">(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 3 - recommencement of treatment after a break in biological medicine of more than 5 years).</p><p align=""justify"">Treatment authorisations under Initial 1, Initial 2 and Initial 3 will be limited to provide for a maximum of 16 weeks of treatment for adalimumab and 14 weeks of treatment for infliximab. From 1 June 2017, a patient must be assessed for response to a course of initial PBS-subsidised treatment following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab, and this assessment must be conducted no later than 4 weeks from the date that course was ceased.</p><p align=""justify"">(2) Continuing treatment.</p><p align=""justify"">Following the completion of an initial treatment course with a specific biological medicine, a patient remains eligible to receive up to 24 weeks per course of continuing treatment with that drug under the First continuing treatment and Subsequent continuing treatment restrictions providing they continue to sustain the response.</p><p align=""justify"">For the first continuing treatment course of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment under the Initial 1, Initial 2 or Initial 3 treatment restrictions.</p><p align=""justify"">For the second and subsequent continuing courses of PBS-subsidised biological medicine treatment, it is recommended that an assessment of a patient&apos;s response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.</p><p align=""justify"">(3) Swapping therapy.</p><p align=""justify"">Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine within the same treatment cycle without having to requalify with respect to the indices of disease severity (i.e. Paediatric Ulcerative Colitis Activity Index (PUCAI) Score, confirmation of ulcerative colitis disease), or the prior conventional therapies of corticosteroids or immunosuppressives.</p><p align=""justify"">A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving treatment (initial or continuing) at the time of the application. However, a patient cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug twice within the same treatment cycle. To ensure a patient receives the maximum treatment opportunities allowed under these swapping arrangements, it is important that they are assessed for response to every course of treatment.</p><p align=""justify"">(4) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.</p><p align=""justify"">A patient who wishes to recommence treatment following a break in PBS-subsidised biological medicine therapy of at least 5 years, must requalify under Initial 3 treatment restriction and meet the relevant criteria with respect to the indices of disease severity.</p>","Y","N","N","null","null","N","2021-07-01","N","4708"
"27499_C","null","null","null","null","null","<p align=""justify"">Hepatic decompensation and failure, in some cases fatal, have been reported in post-marketing reports in patients with moderate to severe hepatic impairment when dosed incorrectly.</p>","N","Y","N","null","null","N","2021-09-01","N","4708"
"27500_N","null","null","null","null","null","<p align=""justify"">Laboratory readings requested in this authority application must be no older than 52 weeks.</p>","Y","N","N","null","null","N","2021-09-01","N","4708"
"27501_N","null","null","null","null","null","<p align=""justify"">In accordance with the dosing directions in the approved Product Information, the 10 mg presentation is not PBS listed for initiation of treatment.</p>","Y","N","N","null","null","N","2021-09-01","N","4708"
"27533_N","null","null","null","null","null","<p align=""justify"">For dose titration involving the 100 mg or 150 mg strength, refer to the dose titration listing for these strengths with pack sizes of 14 units. Avoid prescribing a &apos;broken&apos; quantity under this listing<b>.</b></p>","Y","N","N","null","null","N","2021-09-01","N","4708"
"27544_N","null","null","null","null","null","<p align=""justify"">Requests for increases in the maximum quantity (packs) up to 3 times that stated may be authorised.</p>","Y","N","N","null","null","N","2021-09-01","N","4708"
"27581_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form adrenaline 1 mg/mL ampoules for injection in a pack size of 10 can be substituted for a pack size of 5 in the case of a shortage.</p>","Y","N","N","null","null","N","2021-08-01","N","4708"
"27656_N","null","null","null","null","null","<p align=""justify"">This product is not PBS-subsidised for the treatment of previously untreated CD30 positive cutaneous T-cell lymphoma.</p>","Y","N","N","null","null","N","2021-09-01","N","4708"
"27706_N","null","null","null","null","null","<p align=""justify"">TREATMENT OF ADULT PATIENTS WITH A HISTORY OF JUVENILE IDIOPATHIC ARTHRITIS</p><p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, etanercept and tocilizumab for a patient over 18 years who has a history of juvenile idiopathic arthritis with onset prior to the age of 18 years. Where the term &apos;biological medicine&apos; appears in notes and restrictions, it refers to adalimumab, etanercept and tocilizumab only.</p><p align=""justify"">A patient is eligible for PBS-subsidised treatment with only 1 of the 3 biological medicines at any one time.</p><p align=""justify"">From 1 April 2014, a patient receiving PBS-subsidised biological medicine therapy is considered to be in a treatment cycle where they may swap to an alternate biological medicine without having to experience a disease flare. Under these interchangeability arrangements, within a single treatment cycle, a patient may:</p><p align=""justify"">(i) continue to receive long-term treatment with a PBS-subsidised biological medicine while they continue to show a response to therapy; and</p><p align=""justify"">(ii) fail to respond or to sustain a response to each PBS-subsidised biological medicine once only. Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment.</p><p align=""justify"">Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven&apos;s Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.</p><p align=""justify"">Once a patient has either failed or ceased to sustain a response to treatment 3 times, they are deemed to have completed a single treatment cycle and they must have, at a minimum, a 5 year break in PBS-subsidised biological medicine therapy before they are eligible to receive further PBS-subsidised biological medicine therapy.</p><p align=""justify"">The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised biological medicine was approved to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">A patient who received PBS-subsidised biological medicine treatment immediately prior to 1 April 2014 is considered to be in their first cycle as of 1 April 2014. A patient who has had a break in biological medicine treatment of at least 24 months immediately prior to making a new application, on or after 1 April 2014, will commence a new treatment cycle under the Initial 3 treatment restriction</p><p align=""justify"">A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of less than 24 months may commence a further course of treatment within the same treatment cycle under the Initial 2 treatment restriction.</p><p align=""justify"">A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of more than 24 months must commence a new treatment cycle under the Initial 3 treatment restriction.</p><p align=""justify"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""justify"">How to prescribe PBS-subsidised biological medicine therapy after 1 April 2014.</p><p align=""justify"">(1) Initial treatment.</p><p align=""justify"">Applications for initial treatment should be made where:</p><p align=""justify"">(i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy (Initial 1 - New patient); or</p><p align=""justify"">(ii) a patient has received prior PBS-subsidised biological medicine therapy (initial or continuing) and wishes to trial an alternate medicine (Initial 2 - Change or recommencement of treatment after a break in biological medicine of less than 24 months) [further details are under &apos;Swapping therapy&apos; below]; or</p><p align=""justify"">(iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 24 months with the same medicine (Initial 2 - Change or recommencement of treatment after a break in biological medicine therapy of less than 24 months); or</p><p align=""justify"">(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 24 months (Initial 3 - recommencement of treatment after a break in biological medicine of more than 24 months).</p><p align=""justify"">Initial treatment authorisations will be limited to provide for a maximum of 16 weeks of therapy.</p><p align=""justify"">A patient must be assessed for response to any course of initial PBS-subsidised treatment following a minimum of 12 weeks of therapy and conducted no later than 4 weeks from the cessation of the treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment.</p><p align=""justify"">(2) Continuing treatment.</p><p align=""justify"">Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response.</p><p align=""justify"">It is recommended that a patient be reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.</p><p align=""justify"">A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to Services Australia where applicable. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p><p align=""justify"">Adalimumab and infliximab only:</p><p align=""justify"">Following the completion of an initial treatment course with a specific biological medicine, a patient remains eligible to receive up to 24 weeks per course of continuing treatment under the First continuing treatment and Subsequent continuing treatment restrictions with that drug providing they continue to sustain the response.</p><p align=""justify"">It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.</p><p align=""justify"">(3) Swapping therapy.</p><p align=""justify"">Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine without having to requalify with respect to the indices of disease severity (joint count and ESR/CRP) or the prior non-biological medicine therapy requirements, except if the patient has had a break in therapy of more than 24 months who would then need to requalify under the Initial 3 restrictions with respect to the indices of disease severity.</p><p align=""justify"">A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug within the same treatment cycle.</p><p align=""justify"">To ensure a patient receives the maximum treatment opportunities allowed under the interchangeability arrangements, it is important that they are assessed for response to every course of treatment approved, within the timeframes specified in the relevant restriction.</p><p align=""justify"">(4) Baseline measurements to determine response.</p><p align=""justify"">A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements of the joint count submitted with the first authority application for a biological medicine. However, prescribers may provide a new baseline measurement any time that an initial treatment authority application is submitted within a treatment cycle and the eligibility for continuing treatment must be assessed according to these revised baseline measurements.</p><p align=""justify"">(5) Recommencement of treatment after 24 months break in PBS-subsidised therapy.</p><p align=""justify"">A patient who wishes to trial a second or subsequent treatment cycle following a break in PBS-subsidised biological medicine therapy of at least 24 months, must qualify under the Initial 3 restriction and meet the relevant criteria and index of disease severity.</p>","Y","N","N","null","null","N","2021-09-01","N","4708"
"27713_N","null","null","null","null","null","<p align=""justify"">The intent of this listing is to provide doses at weeks 0, 1 and 2. For treatment at week 4 and beyond, see the &apos;Continuing treatment&apos; listing.</p>","Y","N","N","null","null","N","2021-09-01","N","4708"
"27741_N","null","null","null","null","null","<p align=""justify"">Authority approval for an increased maximum quantity, up to 3 times the stated quantity (in packs), may be sought.</p>","Y","N","N","null","null","N","2021-09-01","N","4708"
"27780_C","null","null","null","null","null","<p align=""justify"">It is recommended that the potential for immunosuppression with long term use of this drug be clinically reviewed after at least 24 months of treatment, if not already reviewed.</p>","N","Y","N","null","null","N","2021-10-01","N","4708"
"27801_N","null","null","null","null","null","<p align=""justify"">Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors for the purposes of this restriction are abemaciclib, palbociclib and ribociclib.</p>","Y","N","N","null","null","N","2021-11-01","N","4708"
"27898_N","null","null","null","null","null","<p align=""justify"">For the next authority approval following this one, aim to conduct and submit the PASI assessment at approximately 4 weeks prior to when a new authority application is due to ensure uninterrupted supply.</p>","Y","N","N","null","null","N","2021-10-01","N","4708"
"28006_N","null","null","null","null","null","<p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, and etanercept for patients who have severe active juvenile idiopathic arthritis.</p><p align=""justify"">This listing is a temporary listing and is only to be used to transfer patients currently receiving PBS subsidised treatment with tocilizumab to another biological medicine, where tocilizumab is not available due to the current critical medicines shortage.</p><p align=""justify"">Alternative biological medicine refers to adalimumab and etanercept.</p><p align=""justify"">Should it be necessary to continue treatment with the alternative biological medicine, applications must be made under the relevant &apos;First continuing - Temporary listing&apos; PBS listing.</p>","Y","N","N","null","null","N","2021-11-01","N","4708"
"28008_N","null","null","null","null","null","<p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, and etanercept for patients over 18 years who have a history of juvenile idiopathic arthritis with onset prior to the age of 18 years.</p><p align=""justify"">This listing is a temporary listing and is only to be used to transfer patients currently receiving PBS-subsidised treatment with tocilizumab to another biological medicine, where tocilizumab is not available due to the current critical medicines shortage.</p><p align=""justify"">Alternative biological medicine refers to adalimumab and etanercept.</p><p align=""justify"">Should it be necessary to continue treatment with the alternative biological medicine, applications must be made under the relevant &apos;First continuing - Temporary listing&apos; PBS listing.</p>","Y","N","N","null","null","N","2021-11-01","N","4708"
"28024_N","null","null","null","null","null","<p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines for adults with severe active rheumatoid arthritis. This listing is a temporary listing and is only to be used to transfer patients back to tocilizumab from another biological medicine, where treatment was changed due to unavailability of tocilizumab due to the critical medicines shortage.</p><p align=""justify"">The term biological medicine refers to the tumour necrosis factor (TNF) alfa antagonists (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), the chimeric anti-CD20 monoclonal antibody (rituximab), the interleukin-6 inhibitor (tocilizumab), the T-cell co-stimulation modulator (abatacept) and the Janus kinase (JAK) inhibitors (baricitinib, tofacitinib, upadacitinib).</p>","Y","N","N","null","null","N","2021-12-01","N","4708"
"28088_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form follitropin alfa cartridge (Ovaleap) and pharmaceutical benefits that have the form follitropin alfa single pen device (Gonal-f Pen), in the same corresponding strength, are equivalent for the purposes of substitution.</p><p align=""justify"">Where the Ovaleap brand is supplied, the separate pen device is to be supplied to the patient where required as it is not packaged with the cartridges. The pen device for the Ovaleap brand can be obtained by contacting the pharmaceutical wholesaler, or, the sponsor directly.</p>","Y","N","N","null","null","N","2021-12-01","N","4708"
"28091_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the brand Hydromorphone hydrochloride oral solution, USP (Medsurge) and pharmaceutical benefits that have the brand Hikma are equivalent for the purposes of substitution in the case of a shortage.</p>","Y","N","N","null","null","N","2024-01-01","N","4708"
"28245_N","null","null","null","null","null","<p align=""justify"">The Eczema Area and Severity Index (EASI) referenced in this restriction is that described in the following literature publications:</p><p align=""justify"">Chalmers JR et al. Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME).<i> British Journal of Dermatology</i> 2014 December;171(6):1318-25.</p><p align=""justify"">Schmitt J et al. HOME initiative collaborators. The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials. <i>The Journal of Allergy and Clinical Immunology </i>2014 October;134(4):800-7</p>","Y","N","N","null","null","N","2022-02-01","N","4708"
"28246_N","null","null","null","null","null","<p align=""justify"">The Physician&apos;s Global Assessment (5-point scale) referenced in this restriction is that described in the following literature publication:</p><p align=""justify"">Fatumura M et al. <i>Journal of the American Academy of Dermatology</i> 2016; 64(2): 288-94</p><p align=""justify"">The overall appearance of dermatitis lesions is rated as 4 (severe) if the lesions are best described as featuring: deep/dark red erythema, with marked and extensive induration/papulation; excoriation and oozing/crusting are present.</p>","Y","N","N","null","null","N","2022-02-01","N","4708"
"28247_N","null","null","null","null","null","<p align=""justify"">Dose changes subsequent to this authority application, whether they occur during an initial treatment or continuing treatment phase, may occur under the &apos;Dose change&apos; treatment phase listing.</p>","Y","N","N","null","null","N","2022-02-01","N","4708"
"28301_N","null","null","null","null","null","<p align=""justify"">Current Medicare Benefits Schedule item numbers for extracorporeal photopheresis for the treatment of chronic graft-versus host disease are: 13761 and 13762.</p>","Y","N","N","null","null","N","2022-03-01","N","4708"
"28302_N","null","null","null","null","null","<p align=""justify"">A new treatment episode is considered to have begun when treatment with this drug/extracorporeal photopheresis follows a relapse of the condition. There is no limit on the number of new treatment cycles that may be commenced, but re-treatment following a relapse must not commence under &apos;Continuing treatment&apos;.</p>","Y","N","N","null","null","N","2022-03-01","N","4708"
"28316_N","null","null","null","null","null","<p align=""justify"">A maximum quantity (vials) of 12 with 1 repeat prescription provides 24 doses of this drug. An additional 25<sup>th</sup> dose can be prescribed under this treatment phase by issuance of a further prescription made out for one vial with nil repeats. Alternatively, the 25<sup>th</sup> dose can be sought under the &apos;Continuing treatment&apos; restriction<i>.</i> The 26<sup>th</sup> dose and onwards must be requested under the &apos;Continuing treatment&apos; restriction.</p>","Y","N","N","null","null","N","2022-03-01","N","4708"
"28323_N","null","null","null","null","null","<p align=""justify"">Up to 2 additional repeats to that stated in this listing may be sought.</p>","Y","N","N","null","null","N","2022-03-01","N","4708"
"28339_N","null","null","null","null","null","<p align=""justify"">For the purposes of administering this restriction, current Bruton&apos;s tyrosine kinase inhibitors are: acalabrutinib, ibrutinib, zanubrutinib</p>","Y","N","N","null","null","N","2022-03-01","N","4708"
"28449_N","null","null","null","null","null","<p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a &apos;Balance of Supply&apos; patient must qualify under the &apos;First Continuing Treatment&apos; criteria.</p>","Y","N","N","null","null","N","2022-03-01","N","4708"
"28450_N","null","null","null","null","null","<p align=""justify"">This Balance of Supply restriction will cease to operate from 5 years after the date specified in the clinical criteria.</p>","Y","N","N","null","null","N","2022-03-01","N","4708"
"28482_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF PATIENTS WITH CHRONIC MYELOID LEUKAEMIA - FIRST-LINE THERAPY</b></p><p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of tyrosine kinase inhibitors (TKI) agents for the chronic phase of chronic myeloid leukaemia (CML) in the first line treatment setting.</p><p align=""justify"">Where the term TKI agent appears in the following notes and restrictions it refers to imatinib mesilate, dasatinib or nilotinib.</p><p align=""justify"">Patients are eligible for PBS-subsidised treatment with only one TKI agent at any one time and must not be receiving concomitant interferon alfa therapy. Eligible patients may only swap between TKI agents if they have not failed prior PBS-subsidised treatment with that agent.</p><p align=""justify"">1. Initial First-line treatment</p><p align=""justify"">A patient will be able to be prescribed any of imatinib mesilate, dasatinib or nilotinib within the initial 18 month treatment period, as long as only one agent is used at a time and providing the patient has not failed to respond to any one of these TKIs.</p><p align=""justify"">During the initial 18 month treatment period, switching between approved first-line agents may only occur for reasons of intolerance, not failure to respond.</p><p align=""justify"">2. Continuing First-line treatment</p><p align=""justify"">Patients must maintain a major cytogenetic response or have a peripheral blood BCR-ABL of less than 1% on the international scale (Blood 108:28-37,2006) to receive continuing therapy.</p><p align=""justify"">For continuing applications patients must demonstrate a response to PBS-subsidised treatment and a pathology report demonstrating the patient has responded to the initial course of treatment must be documented in the patient&apos;s medical records.</p><p align=""justify"">During continuing therapy beyond the initial 18 month treatment period, switching between approved first-line agents may only occur for reason of intolerance. Where there is failure to respond, switching may only occur through application for prescription of second-line agents.</p><p align=""justify"">Where a patient has previously received PBS-subsidised treatment with imatinib mesilate, dasatinib or nilotinib no approval will be granted for PBS-subsidised re-treatment in the chronic phase of chronic myeloid leukaemia, where that patient has at any time failed to meet the response criteria whilst on that TKI agent.</p><p align=""justify"">3. Authority approval requirements</p><p align=""justify"">Response criteria to initial first-line treatment with imatinib mesilate, dasatinib or nilotinib:<br/> For the purposes of assessing response to PBS-subsidised treatment with imatinib mesilate, dasatinib or nilotinib either cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale, must be conducted and the results must be documented in the patient&apos;s medical records. For bone marrow analyses, where the standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be conducted and the results must be documented in the patient&apos;s medical records. The cytogenetic or peripheral blood quantitative PCR analyses must be conducted and the results must be documented in the patient&apos;s medical records within 18 months of the commencement of treatment with imatinib, dasatinib or nilotinib (patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% is demonstrable by 18 months are eligible to receive continuing treatment with that agent).</p><p align=""justify"">4. Definitions of response</p><p align=""justify"">A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells.<br/> A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response.</p><p align=""justify"">5. Definitions of loss of response</p><p align=""justify"">Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy.<br/> Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor therapy.</p>","Y","N","Y","null","null","N","2022-03-01","N","4708"
"28496_N","null","null","null","null","null","<p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","Y","N","Y","null","null","N","2022-03-01","N","4708"
"28500_N","null","null","null","null","null","<p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","Y","N","Y","null","null","N","2022-03-01","N","4708"
"28501_N","null","null","null","null","null","<p align=""justify"">Authority applications for increased quantities/ repeats (where relevant) may be made by telephone to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","Y","N","Y","null","null","N","2022-03-01","N","4708"
"28546_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF PATIENTS WITH CHRONIC MYELOID LEUKAEMIA - SECOND-LINE THERAPY</b></p><p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of tyrosine kinase inhibitors (TKI) agents for all phases of chronic myeloid leukaemia (CML) in the second-line treatment setting.</p><p align=""justify"">Where the term TKI agent appears in the following notes and restrictions it refers to dasatinib or nilotinib.</p><p align=""justify"">Patients are eligible for PBS-subsidised second-line treatment of CML if they have experienced treatment failure in the first-line treatment setting.</p><p align=""justify"">Patients are eligible for PBS-subsidised treatment with either dasatinib or nilotinib if they have not failed prior PBS-subsidised treatment with either dasatinib or nilotinib in the first-line treatment setting. Patients are eligible for PBS-subsidised treatment with either dasatinib or nilotinib at any one time and must not be receiving concomitant interferon alfa therapy. Eligible patients may only swap between these agents if they have not failed prior PBS-subsidised treatment with that agent and may only occur for reasons of intolerance.</p><p align=""justify"">Dasatinib is PBS-subsidised for all phases of CML (chronic, accelerated and blast phase) in the second-line treatment setting.</p><p align=""justify"">Nilotinib is PBS-subsidised for chronic and accelerated phase CML in the second-line setting. Nilotinib is not approved for patients in blast crisis in any (first, second, third-line) treatment setting.</p><p align=""justify"">Imatinib is not approved for second-line treatment of CML.</p><p align=""justify"">1. Initial second-line treatment</p><p align=""justify"">A patient will be able to be prescribed either dasatinib or nilotinib within the initial 18 month treatment period as second-line therapy, as long as only one agent is approved at a time and providing the patient did not fail that drug as first-line therapy.<br/> During the initial 18 month treatment period, switching between approved second-line agents may only occur for reasons of intolerance, not failure of response.</p><p align=""justify"">2. Continuing treatment for second-line treatment</p><p align=""justify"">For continuing applications, patients must demonstrate response to PBS-subsidised treatment as follows:</p><p align=""justify"">(i) within 18 months of the commencement of treatment, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108:28-37,2006) has been demonstrated may receive authorisation for a further 12 months of treatment; and</p><p align=""justify"">(ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained.</p><p align=""justify"">All pathology reports must be documented in the patient&apos;s medical records.</p><p align=""justify"">During second line continuing treatment beyond the initial 18 month treatment period, switching between approved second line TKI agents may only occur for reason of intolerance. Where there is failure of response, switching may only occur through application for prescription of a third line agent.</p><p align=""justify"">3. Authority approval requirements</p><p align=""justify"">Response criteria to initial treatment with dasatinib or nilotinib:</p><p align=""justify"">For the purposes of assessing response to PBS-subsidised treatment with dasatinib or nilotinib, either cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale, must be conducted and the results must be documented in the patient&apos;s medical records. For bone marrow analyses, where the standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be conducted and the results must be documented in the patient&apos;s medical records. The cytogenetic or peripheral blood quantitative PCR analyses must be conducted and the results must be documented in the patient&apos;s medical records within 18 months of the commencement of treatment with dasatinib or nilotinib (patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% is demonstrable by 18 months are eligible to receive continuing treatment with that agent).</p><p align=""justify"">4. Definitions of response</p><p align=""justify"">A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells.<br/> A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response.</p><p align=""justify"">5. Definitions of loss of response</p><p align=""justify"">Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy.<br/> Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor therapy.</p>","Y","N","Y","null","null","N","2022-03-01","N","4708"
"28563_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF PATIENTS WITH CHRONIC MYELOID LEUKAEMIA - THIRD-LINE THERAPY</b></p><p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of tyrosine kinase inhibitors (TKI) agents for all phases of chronic myeloid leukaemia (CML) in the third-line treatment setting.</p><p align=""justify"">Where the term TKI agent appears in the following notes and restrictions it refers to dasatinib or nilotinib.</p><p align=""justify"">Patients are eligible for PBS-subsidised third-line treatment of CML if they have experienced treatment failure in the second-line treatment setting.</p><p align=""justify"">Patients are eligible for PBS-subsidised treatment with either dasatinib or nilotinib if they have not failed prior PBS-subsidised treatment with either dasatinib or nilotinib in the first-line or second-line treatment setting. Patients are eligible for PBS-subsidised treatment with either dasatinib or nilotinib at any one time and must not be receiving concomitant interferon alfa therapy. Eligible patients may only swap between these agents if they have not failed prior PBS-subsidised treatment with that agent and may only occur for reasons of intolerance.</p><p align=""justify"">Dasatinib is PBS-subsidised for all phases of CML (chronic, accelerated and blast phase) in the third-line treatment setting.</p><p align=""justify"">Nilotinib is PBS-subsidised for chronic and accelerated phase CML in the third-line setting. Nilotinib is not approved for patients in blast crisis in any (first, second, third-line) treatment setting.</p><p align=""justify"">Imatinib is not approved for third-line treatment of CML.</p><p align=""justify"">1. Initial third-line treatment</p><p align=""justify"">Third-line treatment with a TKI can only be approved when imatinib has been used for first-line treatment. Patients will only be approved for PBS-subsidised treatment with one third-line agent.</p><p align=""justify"">2. Continuing treatment for third-line treatment</p><p align=""justify"">For continuing applications, patients must demonstrate response to PBS-subsidised treatment as follows:</p><p align=""justify"">(i) within 18 months of the commencement of treatment, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) has been demonstrated may receive authorisation for a further 12 months of treatment; and</p><p align=""justify"">(ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained.</p><p align=""justify"">All pathology reports must be documented in the patient&apos;s medical records.</p><p align=""justify"">3. Authority approval requirements</p><p align=""justify"">Response criteria to initial treatment with dasatinib or nilotinib:</p><p align=""justify"">For the purposes of assessing response to PBS-subsidised treatment with dasatinib or nilotinib, either cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale, must be conducted and the result must be documented in the patient&apos;s medical records. For bone marrow analyses, where the standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be conducted and the results must be documented in the patient&apos;s medical records. The cytogenetic or peripheral blood quantitative PCR analyses must be conducted and the results must be documented in the patient&apos;s medical records within 18 months of the commencement of treatment with dasatinib or nilotinib (patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% is demonstrable by 18 months are eligible to receive continuing treatment with that agent).</p><p align=""justify"">4. Definitions of response</p><p align=""justify"">A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells.<br/> A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response.</p><p align=""justify"">5. Definitions of loss of response</p><p align=""justify"">Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor therapy.</p>","Y","N","Y","null","null","N","2022-03-01","N","4708"
"28584_N","null","null","null","null","null","<p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","Y","N","Y","null","null","N","2022-03-01","N","4708"
"28585_N","null","null","null","null","null","<p align=""justify"">1. Continuing treatment.</p><p align=""justify"">For first continuing applications patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated may receive authorisation for a further 12 months of treatment.</p><p align=""justify"">2. Authority approval requirements.</p><p align=""justify"">Response criteria to treatment with ponatinib:</p><p align=""justify"">For the purposes of assessing response to PBS-subsidised treatment with ponatinib, either cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale, must be conducted. For bone marrow analyses, where the standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be conducted. The cytogenetic or peripheral blood quantitative PCR analyses must be conducted within 18 months of the commencement of treatment with ponatinib (patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% is demonstrable by 18 months are eligible to receive first continuing treatment with this drug).</p><p align=""justify"">Thereafter, at no greater than 12 month intervals a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% must be sustained to receive subsequent continuing treatments with this drug.</p><p align=""justify"">3. Definitions of response.</p><p align=""justify"">A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells.</p><p align=""justify"">A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006).</p><p align=""justify"">4. Definitions of loss of response.</p><p align=""justify"">Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor therapy.</p><p align=""justify"">Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor therapy.</p>","Y","N","Y","null","null","N","2022-03-01","N","4708"
"28601_N","null","null","null","null","null","<p align=""justify"">WARNING: Ravulizumab increases the risk of meningococcal infections (septicaemia and/or meningitis).</p><p align=""justify"">Please consult the approved PI for information about vaccination against meningococcal infection.</p>","Y","N","N","null","null","N","2022-03-01","N","4708"
"28663_N","null","null","null","null","null","<p align=""justify"">It is recommended that patients have previously received 4 weeks of PBS-subsidised initial oral lead-in treatment with cabotegravir and rilpivirine.</p>","Y","N","N","null","null","N","2022-04-01","N","4708"
"28664_N","null","null","null","null","null","<p align=""justify"">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","Y","N","N","null","null","N","2022-04-01","N","4708"
"28690_N","null","null","null","null","null","<p align=""justify"">This pharmaceutical benefit is not for the treatment of chronic obstructive pulmonary disease (COPD).</p>","Y","N","N","null","null","N","2022-04-01","N","4708"
"28755_N","null","null","null","null","null","<p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","Y","N","Y","null","null","N","2022-07-01","N","4708"
"28785_N","null","null","null","null","null","<p align=""justify"">Other disease modifying therapies for this condition are: (i) nusinersen, (ii) risdiplam.</p>","Y","N","N","null","null","N","2022-05-01","N","4708"
"28786_N","null","null","null","null","null","<p align=""justify"">Recognised hospitals in the management of SMA are Queensland Children&apos;s Hospital (Brisbane), Royal Children&apos;s Hospital Melbourne, Monash Children&apos;s Hospital (Melbourne), John Hunter Hospital (Newcastle), Sydney Children&apos;s Hospital Randwick, Children&apos;s Hospital at Westmead, Adelaide Women and Children&apos;s Hospital and Perth Children&apos;s Hospital.</p>","Y","N","N","null","null","N","2022-05-01","N","4708"
"28787_N","null","null","null","null","null","<p align=""justify"">Accredited treatment centres and suppliers are those organisations accredited by the Gene Technology Regulator under section 92 of the <i>Gene Technology Act 2000</i>.</p><p align=""justify"">The following website provides a list of accredited organisations and may update without notice:</p><p align=""justify"">https://www.ogtr.gov.au/what-weve-approved/accredited-organisations</p>","Y","N","N","null","null","N","2022-05-01","N","4708"
"28790_N","null","null","null","null","null","<p align=""justify"">A developmental specialist is a medical practitioner who is a member of the Neurodevelopmental and Behavioural Paediatric Society of Australasia.</p>","Y","N","N","null","null","N","2024-07-01","N","4708"
"28812_N","null","null","null","null","null","<p align=""justify"">Increases in the maximum quantity to provide sufficient treatment duration for 30 days treatment per dispensing at the maximum recommended dose as per the approved Product Information, may be sought.</p>","Y","N","N","null","null","N","2024-07-01","N","4708"
"28834_N","null","null","null","null","null","<p align=""justify"">For the next authority application after this application, continue treatment through the &apos;Treatment phase: Continuing/maintenance treatment of either symptomatic Type I, II or IIIa SMA, or of a patient commenced on this drug under the pre-symptomatic SMA listing&apos; under the indication: &apos;Spinal muscular atrophy (SMA)&apos;.</p>","Y","N","N","null","null","N","2022-05-01","N","4708"
"28835_N","null","null","null","null","null","<p align=""justify"">For the next authority application after this application, continue treatment through the &apos;Treatment phase: Continuing treatment&apos; under the indication: &apos;Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)&apos;.</p>","Y","N","N","null","null","N","2022-05-01","N","4708"
"28846_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms darunavir tablet 600 mg, 2 x 30 and darunavir tablet 600 mg (as ethanolate), 60 are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2022-05-01","N","4708"
"28881_C","null","null","null","null","null","<p align=""justify"">This medicine contains a cytotoxic component and causes chemotherapy-like toxicity, in particular, it can cause severe or life-threatening neutropenia and severe diarrhoea. For further information, refer to the Product Information.</p>","N","Y","N","null","null","N","2022-05-01","N","4708"
"28912_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form etanercept injection 50 mg/mL, 4 x 1 mL syringes and pharmaceutical benefits that have the form etanercept injection 50 mg/mL, 4 x 1 mL pen devices are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2022-05-01","N","4708"
"28927_N","null","null","null","null","null","<p align=""justify"">Use with caution if arterial disease present and avoid if severe arterial disease.</p>","Y","N","N","null","null","N","2022-05-01","N","4708"
"28943_C","null","null","null","null","null","<p align=""justify"">Nirmatrelvir with ritonavir has significant drug-drug interactions. Please refer to the TGA approved Paxlovid Product Information. Prescribers and dispensers should carefully review a patient&apos;s concomitant medications including over-the-counter medications, herbal supplements, and recreational drugs.</p>","N","Y","N","null","null","N","2022-05-01","N","4708"
"28962_N","null","null","null","null","null","<p align=""justify"">This authority approval must be sought by the specified specialist prescriber.</p>","Y","N","N","null","null","N","2022-06-01","N","4708"
"28979_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form rituximab 100 mg/10 mL injection, 2 x 10 mL vials and pharmaceutical benefits that have the form rituximab 100 mg/10 mL injection, 10 mL vial are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2022-06-01","N","4708"
"29000_N","null","null","null","null","null","<p align=""justify"">For a patient who has received non-PBS-subsidised supply of this drug, apply under an &apos;Initial treatment&apos; phase listing provided that they meet all stated PBS eligibility criteria.</p>","Y","N","N","null","null","N","2022-07-01","N","4708"
"29041_C","null","null","null","null","null","<p align=""justify"">In the first few months after starting immunotherapy, a transient tumour flare may occur that may be mistaken as disease progression despite an overall positive response to treatment.</p>","N","Y","N","null","null","N","2022-10-01","N","4708"
"29061_N","null","null","null","null","null","<p align=""justify"">Where there is already an approved authority prescription for the IV formulation, an authority application for this subcutaneously administered form can be made under one of:</p><p align=""justify"">(1) The Balance of Supply listing - apply under this listing if the treatment phase (Initial treatment, First Continuing treatment, Subsequent Continuing treatment) is yet to be completed; the following authority application is to be under a Continuing treatment listing.</p><p align=""justify"">(2) A Continuing treatment listing - apply under one of these types of listings where a treatment phase is concluding/has concluded; this typically occurs for the dose due at treatment week 16, 40, 64, 88 etc.</p>","Y","N","N","null","null","N","2022-08-01","N","4708"
"29102_N","null","null","null","null","null","<p align=""justify"">Non-steroidal aromatase inhibitors for the purposes of this restriction are anastrozole and letrozole.</p>","Y","N","N","null","null","N","2022-08-01","N","4708"
"29190_N","null","null","null","null","null","<p align=""justify"">Authority applications for increased quantities/repeats (where relevant) may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","Y","N","Y","null","null","N","2022-07-01","N","4708"
"29247_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF ADULT PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS</b></p><p align=""justify"">The following information applies to Pharmaceutical Benefits Scheme (PBS) benefits for the indication of moderate to severe ulcerative colitis (MSUC). Patients are eligible for one PBS-subsidised drug treatment indicated for MSUC at any one time.</p><p align=""justify"">Where the term &apos;biological medicine&apos; appears in this note and restrictions, it refers to any PBS benefit indicated for MSUC.</p><p align=""justify"">Some benefits are not biological medicines, but are small molecules. However, for practical purposes, these benefits are included within the term &apos;biological medicine&apos;.</p><p align=""justify"">From 1 July 2021, under the PBS, all adult patients will be able to commence a treatment cycle where they may trial PBS-subsidised biological medicine without having to experience a disease flare when swapping to one of the alternate agents. Under these arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with a PBS-subsidised biological medicine while they continue to show a response to therapy.</p><p align=""justify"">A patient who received PBS-subsidised biological medicine treatment prior to 1 July 2021 is considered to have started their first cycle as of 1 July 2021. Within the same treatment cycle, the same biological medicine cannot be trialled twice. Where 3 biological medicines have failed to provide the patient with an adequate response a treatment cycle is considered complete. There must be a 5-year break in PBS-subsidised therapy before starting the next cycle. The 5-year break is measured from the date of the last approval for PBS-subsidised biological medicine treatment in the most recent cycle to the date of the first application for Initial treatment with a PBS-subsidised biological medicine under the new treatment cycle.</p><p align=""justify"">A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven&apos;s Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.</p><p align=""justify"">Selecting the correct treatment phase listing when applying for authority approval:</p><p align=""justify"">(1) Initial treatment.</p><p align=""justify"">Apply under an Initial 1 treatment listing where the patient has never received a biological medicine.</p><p align=""justify"">(2) Continuing treatment.</p><p align=""justify"">Under no circumstance is Continuing treatment to precede Initial treatment. An authority application for Continuing treatment is not to be made on the same day as Initial treatment.</p><p align=""justify"">(3) Changing therapy.</p><p align=""justify"">Apply under an Initial 2 treatment listing. The indices of disease severity (i.e. Mayo clinic score or partial Mayo clinic score), or the prior corticosteroid therapy and immunosuppressive therapy will not need to be restated. A patient may trial an alternate biological medicine treatment at any time, regardless of whether they are receiving therapy (initial or continuing) at the time of the application. However, they cannot change to a particular biological medicine if they have failed to respond to prior treatment with that drug once within the same treatment cycle. A response assessment to the preceding supply of biological medicine must accompany this Initial 2 treatment authority application.</p><p align=""justify"">(4) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.</p><p align=""justify"">Apply under an Initial 3 treatment listing. Prior corticosteroid and immunosuppressive therapies need not be re-trialled.</p><p align=""justify"">(5) Balance of supply.</p><p align=""justify"">Where the full number of repeat prescriptions have not been requested under any initial or continuing listing, apply for the balance of the supply of the repeats under any treatment phase listing containing the words &quot;balance of supply&quot;.</p>","Y","N","N","null","null","N","2023-05-01","N","4708"
"29271_N","null","null","null","null","null","<p align=""justify"">This drug belongs to the poly (ADP-ribose) polymerase (PARP) inhibitor drug class. The restriction refers to the following PARP inhibitors: olaparib, niraparib</p>","Y","N","N","null","null","N","2022-09-01","N","4708"
"29324_N","null","null","null","null","null","<p align=""justify"">Prescribing/pharmacy claiming: prescribe/claim this benefit through the Section 100 Highly Specialised Drugs Program PBS item code(s) when administered for non-oncology indications. Prescribe/claim this benefit through the Efficient Funding of Chemotherapy PBS item code(s) when administered for oncology indications.</p>","Y","N","N","null","null","N","2022-09-01","N","4708"
"29338_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form glatiramer acetate 40 mg/mL syringes and pharmaceutical benefits that have the form glatiramer acetate 40 mg/mL pen devices are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2022-09-01","N","4708"
"29441_C","null","null","null","null","null","<p align=""justify"">This drug is a category X drug and must not be given to pregnant women. Pregnancy in female patients must be avoided during treatment and for the 6-month period after cessation of treatment. Pregnancy in partners of male patients must be avoided during treatment and for the 3-month period after cessation of treatment.</p>","N","Y","N","null","null","N","2022-09-01","N","4708"
"29447_N","null","null","null","null","null","<p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 888 333.</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">PBS Authorities</p><p align=""justify"">GPO Box 9826</p><p align=""justify"">[Your capital city]</p>","Y","N","N","null","null","N","2022-09-01","N","4708"
"29448_N","null","null","null","null","null","<p align=""justify"">An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Note that the 60 mg pen is limited to dose increments of 0.5 mg and a maximum delivered dose of 30 mg, while the 24 mg pen is limited to 0.2 mg increments and a maximum delivered dose of 12 mg. Rounding (up or down) the weekly dose in mg is permitted to the nearest multiple of 0.5 or 0.2. Note that once opened, a pen is to be discarded after 28 days. Give consideration to strengths and combinations that minimise drug wastage.</p>","Y","N","N","null","null","N","2022-10-01","N","4708"
"29458_N","null","null","null","null","null","<p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) that facilitates approximately 16 weeks of treatment per dispensing based on the Product Information recommended dosing of 0.66 mg/kg/week. Request up to 1 repeat prescription. With 1 repeat prescription, this treatment phase listing intends to provide approximately 32 weeks of treatment.</p><p align=""justify"">See the table located on the following webpage which lists a range of patient weights (kg) and the corresponding number of units and combination of strengths to be sought in an authority application:</p><p align=""justify"">https://www.pbs.gov.au/browse/section100-gh</p>","Y","N","N","null","null","N","2022-10-01","N","4708"
"29469_N","null","null","null","null","null","<p align=""justify"">Prescribe an appropriate amount of drug (maximum quantity in units) that facilitates approximately 13 weeks of treatment per dispensing based on the Product Information recommended dosing of 0.66 mg/kg/week. Request up to 1 repeat prescription. With 1 repeat prescription, this treatment phase listing intends to provide approximately 26 weeks of treatment.</p><p align=""justify"">See the table located on the following webpage which lists a range of patient weights (kg) and the corresponding number of units and combination of strengths to be sought in an authority application:</p><p align=""justify"">https://www.pbs.gov.au/browse/section100-gh</p>","Y","N","N","null","null","N","2022-10-01","N","4708"
"29528_N","null","null","null","null","null","<p align=""justify"">Literature references for various instruments measuring motor function and quality of life in the context of spinal muscular atrophy are:</p><p align=""justify"">Revised Upper Limb Module</p><p align=""justify"">Mazzone et al. 2017. Revised upper limb module for spinal muscular atrophy: Development of a new module. <i>Muscle &amp; Nerve</i> 55(6):869-874</p><p align=""justify"">Hammersmith Functional Motor Scale - Expanded</p><p align=""justify"">Ramsey et al. 2017. Revised Hammersmith Scale for spinal muscular atrophy: A SMA specific clinical outcome assessment tool. <i>PLoS ONE</i> 12(2): e0172346. doi:10.1371/journal.pone.0172346.</p><p align=""justify"">6-Minute Walk Test (6MWT)</p><p align=""justify"">American Thoracic Society. 2002. ATS statement: Guidelines for the six-minute walk test. <i>American Journal of Respiratory and Critical Care Medicine</i> 166(1), pp 111-117</p><p align=""justify"">The National Hearth Foundation of Australia has 6MWT test standardised instructions and recording forms located at: https://www.heartonline.org.au/resources/documents-and-links#exercise</p><p align=""justify"">SMA Health Index</p><p align=""justify"">Zizzi et al. 2021. The Spinal Muscular Atrophy Health Index (SMA-HI): A Novel Outcome for Measuring How a Patient Feels and Functions. <i>Muscle &amp; Nerve</i> 63(10), pp 837-844</p><p align=""justify"">SMA Functional Rating Scale</p><p align=""justify"">Elsheikh et al. 2018. Reliability of Spinal Muscular Atrophy Functional Rating Scale (SMAFRS) in Ambulatory Adults with Spinal Muscular Atrophy. <i>Neurology</i> April (15 Supplement) P4.452</p>","Y","N","N","null","null","N","2022-09-01","N","4708"
"29560_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form fremanezumab 225 mg/1.5 mL syringes and pharmaceutical benefits that have the form fremanezumab 225 mg/1.5 mL pen devices are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2022-10-01","N","4708"
"29634_N","null","null","null","null","null","<p align=""justify"">The intravenously administered presentation of this drug is not PBS listed for this indication at the request of the sponsor.</p>","Y","N","N","null","null","N","2022-10-01","N","4708"
"29646_N","null","null","null","null","null","<p align=""justify"">A patient may only receive PBS-subsidised treatment with one form of long-acting methylphenidate at any one time.</p>","Y","N","N","null","null","N","2022-10-01","N","4708"
"29786_N","null","null","null","null","null","<p align=""justify"">Where both eyes are affected by the condition, a quantity of 2 units can be requested through the same authority application.</p>","Y","N","N","null","null","N","2022-11-01","N","4708"
"29791_N","null","null","null","null","null","<p align=""justify"">Encouraging biosimilar prescribing for treatment naive patients is Government policy. A viable biosimilar market is expected to result in reduced costs for biological medicines, allowing the Government to reinvest in new treatments. Further information can be found on the Medicines webpage (www.health.gov.au/health-topics/medicines).</p>","Y","N","N","null","null","N","2022-11-01","N","4708"
"29914_N","null","null","null","null","null","<p align=""justify"">The date of the decompensation event and date of initiation of treatment with this drug must be documented in the patient&apos;s medical records when PBS-subsidised treatment is initiated.</p>","Y","N","N","null","null","N","2022-12-01","N","4708"
"29959_C","null","null","null","null","null","<p align=""justify"">This drug increases the risk of encapsulated bacterial infections.</p><p align=""justify"">Consult the approved Product Information for information about vaccination against meningococcal, pneumococcal and Haemophilus influenzae type B (Hib) infection.</p>","N","Y","N","null","null","N","2022-12-01","N","4708"
"29960_N","null","null","null","null","null","<p align=""justify"">Complement 5 (C5) inhibitors are defined as eculizumab or ravulizumab</p>","Y","N","N","null","null","N","2022-12-01","N","4708"
"30047_N","null","null","null","null","null","<p align=""justify"">Prior to prescribing this drug, the prescriber must contact the pharmaceutical company to confirm that the patient has received all relevant vaccinations. The prescriber will then be provided with a Controlled Distribution Reference Number (CDRN) and information about the pumps and consumables for use.</p>","Y","N","N","null","null","N","2022-12-01","N","4708"
"30080_C","null","null","null","null","null","<p align=""justify"">Oral azacitidine should not be used interchangeably with injectable azacitidine due to differences in the exposure, dose and schedule of treatment.</p>","N","Y","N","null","null","N","2023-09-01","N","4708"
"30081_C","null","null","null","null","null","<p align=""justify"">This is a category X drug and must not be given to pregnant women. Pregnancy must be avoided during treatment and for at least 6 months following cessation of therapy.</p>","N","Y","N","null","null","N","2023-09-01","N","4708"
"30126_N","null","null","null","null","null","<p align=""justify"">Where an increase in maximum quantity is sought, under no circumstances will a quantity beyond 2 times the listed quantity be approved.</p>","Y","N","N","null","null","N","2023-02-01","N","4708"
"30266_N","null","null","null","null","null","<p align=""justify"">Up to an additional 2 repeat prescriptions (7 in total) may be sought only where dosing is on a 2-weekly schedule in the first 16 weeks of treatment. This listing&apos;s stated number of repeat prescriptions is based on 4-weekly dosing.</p>","Y","N","N","null","null","N","2023-03-01","N","4708"
"30335_N","null","null","null","null","null","<p align=""justify"">The length of a break in therapy is measured from the date that the relevant PBS-subsidised medicine listed for this PBS indication is ceased during the most recent treatment cycle, until the date of the subsequent application for treatment under a new treatment cycle.</p>","Y","N","N","null","null","N","2023-04-01","N","4708"
"30360_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have form pack size mesalazine 1.2 g modified release tablet, 60 and mesalazine 1.2 g modified release tablet, 120 are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2023-04-01","N","4708"
"30379_N","null","null","null","null","null","<p align=""justify"">One capsule of itraconazole 50 mg (Lozanoc) is therapeutically equivalent to one 100 mg capsule of conventional itraconazole capsules. The recommended dose for Lozanoc is therefore half the recommended dose for conventional itraconazole capsules. Lozanoc 50 mg capsules and conventional itraconazole 100 mg capsules are not interchangeable.</p>","Y","N","N","null","null","N","2023-04-01","N","4708"
"30447_C","null","null","null","null","null","<p align=""justify"">The bioavailability on a mg to mg basis of abiraterone combination product and abiraterone single drug product is not equivalent. When changing between abiraterone products, exercise caution in explaining correct dosing directions to the patient.</p>","N","Y","N","null","null","N","2023-05-01","N","4708"
"30459_N","null","null","null","null","null","<p align=""justify"">Ensure that PBS-subsidy is approved for the 920 mcg strength prior to supply of this titration pack. It is advisable to only have the titration pack prescription dispensed at the same time as a prescription for the 920 mcg capsules, or where a supply of the 920 mcg capsules is already in existence (in the case of mid treatment dose interruption).</p>","Y","N","N","null","null","N","2023-05-01","N","4708"
"30561_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form levothyroxine sodium 100 microgram tablet, 200 (Eltroxin and Levothox brands) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2023-06-01","N","4708"
"30562_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form levothyroxine sodium 75 microgram tablet, 200 (Eltroxin and Levothox brands) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2023-06-01","N","4708"
"30563_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form levothyroxine sodium 50 microgram tablet, 200 (Eltroxin and Levothox brands) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2023-06-01","N","4708"
"30564_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form levothyroxine sodium 200 microgram tablet, 200 (Eltroxin and Levothox brands) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2023-06-01","N","4708"
"30594_C","null","null","null","null","null","<p align=""justify"">This drug is a Category D drug and must not be given to pregnant women. If this drug is taken during pregnancy, a teratogenic effect in humans cannot be ruled out. </p>","N","Y","N","null","null","N","2023-06-01","N","4708"
"30624_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF PATIENTS WITH SEVERE ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS</b></p><p align=""justify"">The following information applies to Pharmaceutical Benefits Scheme (PBS) benefits listed with the indication of severe active systemic juvenile idiopathic arthritis (sJIA).</p><p align=""justify""><b>Treatment cycles</b></p><p align=""justify"">From 1 May 2012, a patient receiving PBS-subsidised tocilizumab therapy is considered to be in a treatment cycle. Under these arrangements, within a single treatment cycle, a patient may:</p><ol><li>continue to receive long-term treatment with PBS-subsidised tocilizumab while they continue to show an adequate response to therapy; and</li><li>fail to respond, or to sustain a response, to PBS-subsidised tocilizumab twice.</li></ol><p align=""justify"">A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven&apos;s Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, will not be considered as a treatment failure.</p><p align=""justify"">Where treatment has resulted in an inadequate response on 2 occasions, a treatment cycle is considered to have been completed and there must be a 12-month break in PBS-subsidy from all biological medicines with the PBS indication &apos;severe active systemic juvenile idiopathic arthritis&apos; before starting a new treatment cycle. The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised tocilizumab treatment was prescribed to the date of the first application for initial treatment with tocilizumab under the new treatment cycle.</p><p align=""justify""><b>Prescribing under the correct &apos;Treatment Phase&apos; listing for the authority application</b></p><p align=""justify""><u>Initial treatment</u></p><p align=""justify"">Apply under the &apos;Initial 1&apos; treatment listing where the patient has never received a biological medicine for &apos;severe active systemic juvenile idiopathic arthritis&apos;.</p><p align=""justify""><u>Continuing treatment</u></p><p align=""justify"">Apply under the &apos;Continuing treatment&apos; listing where the patient is experiencing an adequate response as defined in the restriction where there has been no change in prescribed biological medicine. Under no circumstance is continuing treatment to precede initial treatment. An authority prescription for continuing treatment is not to be written on the same day as initial treatment.</p><p align=""justify""><u>Recommencement of treatment after a break of less than 12-months in PBS-subsidised therapy, within the same treatment cycle</u></p><p align=""justify"">Apply under the &apos;Initial 2&apos; treatment listing. The indices of disease severity (joint count, fever and/or CRP level and platelet count) will not need to be restated, except if the patient has had a break in therapy of more than 12 months.</p><p align=""justify""><u>Baseline measurements to determine response</u></p><p align=""justify"">Whether an adequate response to treatment has been demonstrated or not will be based on the relative change from relevant baseline measurements of the joint count, fever and/or CRP level and platelet count provided with the first authority application for a biological medicine. However, prescribers may provide a new baseline measurement any time that an initial authority application is provided with a treatment cycle and the eligibility for continuing treatment should be assessed according to the revised baseline measurement.</p><p align=""justify""><u>Recommencement of treatment after a 12-month break in PBS-subsidised therapy</u></p><p align=""justify"">Apply under the &apos;Initial 3&apos; treatment listing.</p><p align=""justify""><u>Withdrawal of treatment after sustained remission</u></p><p align=""justify"">Withdrawal of treatment with a biological medicine should be considered in a patient who has achieved and sustained complete remission of disease for 12 months. A demonstration of response to the current treatment should be documented in the patient&apos;s medical records at the time treatment is ceased. These results must be provided to Services Australia if subsequent authority applications are required.</p>","Y","N","N","null","null","N","2023-07-01","N","4708"
"30627_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form disopyramide 100 mg capsule in a pack size of 84 can be substituted for a pack size of 100 in the case of a shortage.</p>","Y","N","N","null","null","N","2023-06-01","N","4708"
"30680_N","null","null","null","null","null","<p align=""justify"">Any queries concerning the arrangements to prescribe infliximab, or requests for forms, may be directed to the Veterans&apos; Affairs Pharmaceutical Advisory Centre (VAPAC) on 1800 552 580.</p><p align=""justify"">Written applications for authority to prescribe infliximab should be forwarded to:</p><p align=""justify"">Reply Paid 9998</p><p align=""justify"">Veterans&apos; Affairs Pharmaceutical Advisory Centre (VAPAC)</p><p align=""justify"">Department of Veterans&apos; Affairs</p><p align=""justify"">GPO Box 9998</p><p align=""justify"">BRISBANE QLD 4001</p>","Y","N","N","null","null","N","2023-06-01","N","4708"
"30707_N","null","null","null","null","null","<p align=""justify"">Eptinezumab at a dose of 300 mg, once every twelve weeks, is not subsidised on the PBS.</p>","Y","N","N","null","null","N","2023-08-01","N","4708"
"30760_N","null","null","null","null","null","<p align=""justify"">A Combined Positive Score (CPS) is determined by:</p><p align=""justify"">The number of PD-L1-stained cells (tumour cells, lymphocytes, macrophages) divided by the number of all viable tumour cells (i.e. the total number of: PD-L1-positive tumour cells plus PD-L1-negative tumour cells).</p><p align=""justify"">Although the result of the CPS calculation can exceed 100, the maximum score is defined as CPS 100.</p><p align=""justify"">A minimum of 100 viable tumour cells in the PD-L1-stained slide is required for the specimen to be considered adequate for PD-L1 evaluation.</p>","Y","N","N","null","null","N","2023-09-01","N","4708"
"30819_N","null","null","null","null","null","<p align=""justify"">This product does not contain any vitamins, is low in mineral content and is not intended as a sole source of nutrition.</p>","Y","N","N","null","null","N","2024-11-01","N","4708"
"30913_N","null","null","null","null","null","<p align=""justify"">Somatuline Autogel and Mytolac products are equivalent for the purpose of substitution. Pharmacists should ensure that patients are educated regarding the product differences upon dispensing.</p>","Y","N","N","null","null","N","2023-08-01","N","4708"
"30935_N","null","null","null","null","null","<p align=""justify"">The latest International Workshop on CLL (iwCLL) provides guidance on various aspects of management of CLL/SLL. Notably, two of these are:</p><p align=""justify"">(1) when to treat versus when to monitor the patient without therapy - see &apos;Indications for treatment&apos; section; and</p><p align=""justify"">(2) recognising progressive disease - see &apos;Definition of response, relapse, and refractory disease&apos; section.</p><p align=""justify"">See the following literature reference for details:</p><p align=""justify"">Hallek, M et al. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. <i>Blood</i> vol. 131, 25 (2018): 2745-2760.</p>","Y","N","N","null","null","N","2023-09-01","N","4708"
"30971_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form furosemide 20 mg tablet, 50 and pharmaceutical benefits that have the form furosemide 20 mg tablet, 100 are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2023-09-01","N","4708"
"30999_N","null","null","null","null","null","<p align=""justify"">Various sources of information outline the emetic risk associated with cancer treatment. Examples include the National Comprehensive Cancer Network guidelines (USA), eviQ guidelines and approved Product Information of individual drugs. These examples are not a comprehensive list of which anti-cancer drugs that have moderate to high emesis risk.</p>","Y","N","N","null","null","N","2023-10-01","N","4708"
"31027_N","null","null","null","null","null","<p align=""justify"">For prescriptions written for the Maximum Quantity of 2 inhalers (units), item code 11301T (2x60 pack) and item code 13258T (1x60 pack) are substitutable when dispensing 2 inhalers.</p>","Y","N","N","null","null","N","2023-09-01","N","4708"
"31028_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form budesonide 400 microgram/actuation + formoterol (eformoterol) fumarate dihydrate 12 microgram/actuation powder for inhalation, 2 x 60 actuations and pharmaceutical benefits that have the form budesonide 400 microgram/actuation + formoterol (eformoterol) fumarate dihydrate 12 microgram/actuation powder for inhalation, 60 actuations are equivalent for the purposes of substitution when dispensing 2 inhalers at one time.</p>","Y","N","N","null","null","N","2023-09-01","N","4708"
"31110_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF ADULT PATIENTS WITH SEVERE CHRONIC PLAQUE PSORIASIS</b></p><p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines adalimumab, bimekizumab, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab and ustekinumab for adult patients with severe chronic plaque psoriasis. Therefore, where the term &apos;biological medicines&apos; appears in notes and restrictions, it refers to adalimumab, bimekizumab, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab only.</p><p align=""justify"">A patient is eligible for PBS-subsidised treatment with only 1 of the above biological medicines at any 1 time.</p><p align=""justify"">A patient who received PBS-subsidised adalimumab, bimekizumab, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab treatment prior to 1 February 2019 is considered to start their first cycle as of 1 February 2019.</p><p align=""justify"">A patient receiving PBS-subsidised treatment for chronic plaque psoriasis is able to commence a &apos;treatment cycle&apos;, where they may trial biological medicines without having to experience a disease flare, when swapping to an alternate biological medicine. Under these arrangements, within a single cycle, a patient may receive long-term treatment with a biological medicine as long as they sustain a response to therapy.</p><p align=""justify"">Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once. Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment.</p><p align=""justify"">Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven&apos;s Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.</p><p align=""justify"">A patient must be assessed for response to each course of treatment according to the criteria included in the relevant continuing treatment restriction.</p><p align=""justify"">Once a patient has either failed or ceased to sustain a response to treatment 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy before they are eligible to commence the next cycle.</p><p align=""justify"">The duration of the break in therapy will be measured from the date the last prescription for PBS-subsidised treatment was approved in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new cycle.</p><p align=""justify"">A patient who has failed fewer than 3 biological medicines in a treatment cycle and who has a break in therapy of more than 5 years may commence a new treatment cycle under Initial 3 treatment restriction.</p><p align=""justify"">A patient who has failed fewer than 3 biological medicines in a treatment cycle and who has a break in therapy of less than 5 years may commence a further course of treatment within the same treatment cycle under Initial 2 treatment restriction.</p><p align=""justify"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""justify"">How to prescribe PBS-subsidised biological medicine treatment for severe chronic plaque psoriasis.</p><p align=""justify"">There are separate restrictions for both the initial and continuing treatment for psoriasis affecting the whole body, versus psoriasis affecting the face, hands and feet.</p><p align=""justify"">(1) Initial treatment.</p><p align=""justify"">An application for initial treatment should be made where:</p><p align=""justify"">(i) a patient has not received prior PBS-subsidised biological medicine treatment for this condition and wishes to commence such therapy (Initial 1 - New patient); or</p><p align=""justify"">(ii) a patient who has received prior PBS-subsidised biological medicine therapy for this condition (initial or continuing) and wishes to trial an alternate biological medicine (Initial 2 - Change or Recommencement of treatment after a break in biological medicine of less than 5 years) [further details are under (4) &apos;Swapping therapy&apos; below]; or</p><p align=""justify"">(iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 5 years with the same medicine (Initial 2 - Change or Recommencement of treatment after a break in biological medicine of less than 5 years).</p><p align=""justify"">(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 3 - Recommencement of treatment after a break in biological medicine of more than 5 years).</p><p align=""justify"">An application for initial treatment will be limited to provide for a maximum of 16 weeks of therapy for adalimumab, etanercept, ixekizumab, and secukinumab, 20 weeks of therapy for guselkumab, 22 weeks of therapy for infliximab, 24 weeks of therapy for bimekizumab and 28 weeks of therapy for risankizumab, tildrakizumab and ustekinumab.</p><p align=""justify"">It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of their course of initial treatment to ensure uninterrupted biological medicine supply.</p><p align=""justify"">(2) Assessment of response to initial treatment.</p><p align=""justify"">When prescribing initial treatment with a biological medicine, it is recommended that a PASI assessment is conducted after at least 12 weeks of treatment and no later than 4 weeks from the completion of this initial treatment course.</p><p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p><p align=""justify"">(3) Continuing treatment.</p><p align=""justify"">Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response. It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.</p><p align=""justify"">A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to Services Australia where applicable. Where a response assessment is not submitted where applicable, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p><p align=""justify"">Infliximab, adalimumab and etanercept only:</p><p align=""justify"">For the first continuing treatment course of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy under the Initial 1 or Initial 2 treatment restrictions.</p><p align=""justify"">For second and subsequent continuing courses of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.</p><p align=""justify"">(4) Swapping therapy.</p><p align=""justify"">Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine without having to requalify with respect to the indices of disease severity (i.e. a PASI score of greater than 15), or the prior non-biological therapy requirements, except if the patient has had a break in therapy of more than 5 years who would need to requalify with respect to the indices of disease severity.</p><p align=""justify"">A patient who is not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p><p align=""justify"">A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that particular biological medicine within the same cycle or have experienced treatment failure with that particular biological medicine that required permanent treatment withdrawal.</p><p align=""justify"">To ensure a patient receives the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment.</p><p align=""justify"">(5) Baseline measurements to determine response.</p><p align=""justify"">A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline PASI assessment submitted with the first authority application for a biological medicine. However, prescribers may provide new baseline PASI assessments any time that an initial or change or recommencement treatment application is submitted within a treatment cycle and this revised baseline PASI score will be used to assess the patient&apos;s response to the PBS-subsidised treatment.</p><p align=""justify"">To ensure consistency in determining response, the same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of all continuing treatments.</p><p align=""justify"">(6) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.</p><p align=""justify"">A patient who wishes to trial a second or subsequent treatment cycle following a break in PBS-subsidised biological therapy of at least 5 years, must qualify under Initial 3 treatment according to the criteria of the relevant restriction and index of disease severity. A PASI assessment must be conducted prior to application and patient must have a PASI score of greater than 15 for whole body. For the face, hand, foot at least 2 of the 3 PASI symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or the skin area affected is 30% or more of the face, palm of a hand or sole of a foot. The PASI assessment must be no older than 4 weeks at the time of application.</p>","Y","N","N","null","null","N","2023-10-01","N","4708"
"31118_N","null","null","null","null","null","<p align=""justify"">The maximum quantity of drug to be subsidised per dispensing, as well as the number of repeat prescriptions is to be as follows:</p><p align=""justify"">Patient weight greater than 19 kg: up to 3 units per dispensing, with up to 5 repeat prescriptions</p><p align=""justify"">Patient weight between 17 kg to 19 kg: up to 3 units per dispensing, with up to 4 repeat prescriptions</p><p align=""justify"">Patient weight between 13 kg to 17 kg: up to 2 units per dispensing, with up to 5 repeat prescriptions</p><p align=""justify"">Patient weight between 10 kg up to 13 kg: up to 2 units per dispensing, with up to 4 repeat prescriptions</p><p align=""justify"">Patient weight less than 10 kg: up to 1 unit per dispensing, with up to 5 repeat prescriptions</p>","Y","N","N","null","null","N","2023-10-01","N","4708"
"31186_N","null","null","null","null","null","<p align=""justify"">To complete a 24-week course of treatment beyond this authority application, the next authority application (apart from supplies obtained under &apos;Balance of Supply&apos;) is to be under the &apos;completion of course&apos; treatment phase.</p><p align=""justify"">Document the patient&apos;s baseline disease severity indices scores in their medical record, in addition to providing them in this authority application, to ensure:</p><p align=""justify"">(i) the patient&apos;s response to treatment can be quantified from week 12; and</p><p align=""justify"">(ii) in the case of the patient switching therapy for this condition, the baseline scores for the initial application will be available.</p>","Y","N","N","null","null","N","2023-11-01","N","4708"
"31195_C","null","null","null","null","null","<p align=""justify"">Etanercept 50 mg/mL 1ml pen devices and prefilled syringes are intended for use in children and adolescents weighting 62.5kg or more.</p>","N","Y","N","null","null","N","2023-11-01","N","4708"
"31211_N","null","null","null","null","null","<p align=""justify"">The 28-weeks of treatment provided by this listing is intended to cover doses occurring at week 0, week 4 and week 16. Based on body weight, request an amount of biological medicine sufficient to cover a dose occurring at these timepoints. The original prescription is intended to cover a dose at week 0 and the 2 repeat prescriptions available are intended to cover doses at week 4 and week 16.</p><p align=""justify"">The dose due at week 28 is obtained with the first prescription obtained under the &apos;Continuing treatment&apos; phase. Remind the patient to return for clinical review at approximately week 24 of treatment to enable ample time to obtain the authority application enabling dosing from week 28 and onwards.</p><p align=""justify"">Document the patient&apos;s baseline disease severity indices scores in their medical record, in addition to providing them in this authority application, to ensure:</p><p align=""justify"">(i) the patient&apos;s response to treatment can be quantified; and</p><p align=""justify"">(ii) in the case of the patient switching therapy for this condition, the baseline scores for the initial application will be available.</p>","Y","N","N","null","null","N","2023-11-01","N","4708"
"31231_N","null","null","null","null","null","<p align=""justify""><b>PBS AUTHORITY APPLICATIONS FOR SEVERE ACTIVE RHEUMATOID ARTHRITIS</b></p><p align=""justify"">The following information applies to Pharmaceutical Benefits Scheme (PBS) subsidy of the biological medicines for adults with severe active rheumatoid arthritis. Where the term biological medicine appears in the following notes and restrictions it refers to all PBS benefits with the specific PBS indication of: &apos;severe active rheumatoid arthritis&apos;.</p><p align=""justify"">Some benefits are not biological medicines, but are small molecules. However, for practical purposes, these benefits are included within the term &apos;biological medicine&apos;.</p><p align=""justify"">Only one biological medicine is to be PBS-subsidised at any one time for rheumatoid arthritis.</p><p align=""justify"">Upon 5 inadequate responses to biological medicines with the specific PBS indication of &apos;severe active rheumatoid arthritis&apos;, further subsidy is to cease. Where a particular biological medicine has provided an inadequate response, it must not be subsidised again.</p><p align=""justify"">A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Stevens Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered a treatment failure.</p><p align=""justify"">(1) Selecting the correct &apos;Treatment phase&apos; listing to apply under</p><p align=""justify"">Initiating subsidy:</p><p align=""justify"">(i) Apply through &apos;Initial 1 treatment&apos; where a patient has received no prior PBS-subsidised biological medicine treatment; or</p><p align=""justify"">(ii) Apply through &apos;Initial 2 treatment&apos; where one of the following occurs: (a) PBS-subsidised treatment has at least been initiated through any Initial 1 listing, but the prescribed biological medicine is changing, (b) there has been a break in biological medicine of less than 24 months, but resumption of treatment is with the same biological medicine last prescribed, (c) there has been a break in biological medicine of less than 24 months and resumption of treatment is with a different biological medicine to that last prescribed, (d) treatment with rituximab has occurred within the past 24 months and is the most recent therapy prescribed leading up to this authority application, irrespective of the length in time elapsed between the 2 non-rituximab bDMARDs administered before and after rituximab.</p><p align=""justify"">Initial 2 does not require markers of inflammation/joint count to be re-established - those recorded in the first Initial 1 application can remain as baseline measures. Prerequisite DMARD treatments need not be re-proven to be inadequate.</p><p align=""justify"">The prescribed biological medicine may be changed at any time, regardless of whether the current prescribed biological medicine has been obtained through Initial treatment or Continuing treatment. However, the change in biological medicine cannot be back to the same biological medicine where that medicine has provided an inadequate response.</p><p align=""justify"">(iii) Apply through &apos;Initial 3 treatment&apos; where treatment is recommencing following a break in PBS-subsidised therapy of at least 24 months. Initial 3 requires current markers of inflammation/joint count to be re-established. Prerequisite DMARD treatments need not be re-proven to be inadequate. PBS-subsidised therapy in this instance can include rituximab where prescribed as the most recent treatment - the 24 month break in therapy is from the second dose of the prior rituximab course.</p><p align=""justify"">Response assessment to any course of PBS-subsidised biological therapy must follow a minimum of 12 weeks of therapy. Applications made on the same day for Initial treatment and Continuing treatment clearly do reflect this requirement.</p><p align=""justify"">Where a response assessment is not conducted with a &apos;Continuing treatment&apos; application, the biological medicine will be assumed to have failed, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Authority applications for patients who experienced adverse reaction necessitating permanent treatment withdrawal should be submitted through &apos;Initial 2 treatment&apos; or &apos;Initial 3 treatment&apos;. Indicate where the adverse reaction has occurred in the authority application.</p><p align=""justify"">Continuing subsidy:</p><p align=""justify"">Apply under a &apos;Continuing treatment&apos; phase listing only where treatment has initiated through an &apos;Initial treatment&apos; listing and measures of disease control (i.e. ESR/CRP/joint count) demonstrate response following at least 12 weeks of treatment. Continuing treatment should never precede Initial treatment where the same biological medicine is being prescribed.</p><p align=""justify"">The description of &apos;Continuing treatment&apos; means &apos;Continuing treatment of severe rheumatoid arthritis with the same biological medicine&apos;. Where treatment of severe rheumatoid arthritis is continuing with a different biological medicine, &apos;Continuing treatment&apos; is not to be interpreted as meaning &apos;Continuing treatment of severe rheumatoid arthritis with a different biological medicine&apos; - see &apos;Initial 2 treatment&apos; where continuing treatment is with a different biological medicine.</p><p align=""justify"">&apos;Continuing treatment&apos; is to be accessed repeatedly until the prescribed biological medicine is either changed, stops providing an adequate response, or the patient takes a break in treatment.</p><p align=""justify"">Where continuing treatment is divided into &apos;First continuing&apos; and &apos;Subsequent continuing&apos;, the next authority application following immediately after any &apos;Initial treatment&apos; authority application is to be through &apos;First continuing&apos;. Following this, the next authority application is to occur under the &apos;Subsequent continuing&apos; treatment phase. Assuming the drug continues to provide an adequate response, &apos;Subsequent continuing&apos; is to be accessed repeatedly until the prescribed biological medicine is either changed, stops providing an adequate response, or the patient takes a break in treatment.</p><p align=""justify"">Balance of Supply listings:</p><p align=""justify"">Maximum quantities and the number of repeats stated in a PBS-listing are values that prescribers may seek up to, but are not obligated to prescribe. From time to time, there may be particular reasons why a prescriber may elect not to request the full maximum quantity listed, or, the full number of repeat prescriptions. Where this occurs, the intent of Balance of Supply treatment phase listings is to circumvent the need for another written-only authority application to be completed, as a written-only authority application may not be practical in terms of providing timely access to continued treatment.</p><p align=""justify"">Apply under a &apos;Balance of Supply&apos; treatment phase (where available) when either the full maximum quantity or repeat prescriptions available under a particular treatment phase, was not requested and where the biological medicine has had insufficient time to demonstrate an adequate response. Where the preceding supply has been adequate to provide at least 12 weeks of treatment and has resulted in an adequate response, it may be more practical to access further treatment under &apos;Continuing treatment&apos;.</p><p align=""justify"">(2) Baseline measurements to determine response.</p><p align=""justify"">Determination of response to treatment must be based on baseline measurements of the joint count, ESR and/or CRP provided with the first authority application for a biological medicine. However, prescribers may provide new baseline measurements demonstrating elevation of both joint count and markers of inflammation any time that an initial treatment authority application is provided and the eligibility for continuing treatment must be assessed according to these revised baseline measurements.</p><p align=""justify"">To ensure consistency in determining response, the same indices of disease severity used to establish baseline must be used for all subsequent continuing treatment applications. Therefore, where an ESR or CRP level is provided at baseline, an ESR or CRP level respectively must be used to determine response. Similarly, where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints.</p><p align=""justify"">Applications under the Initial 1 treatment restriction for a new patient must include a joint count and ESR and/or CRP measured at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. The results must be no more than 4 weeks old at the time of application.</p><p align=""justify"">Applications under the Initial 3 treatment restriction for recommencement of treatment after a break in biological medicine of more than 24 months must include a joint count and ESR and/or CRP measurement that is no more than 4 weeks old at the time of application.</p>","Y","N","N","null","null","N","2023-11-01","N","4708"
"31253_N","null","null","null","null","null","<p align=""justify"">Eltroxin and Levothox are not interchangeable with Oroxine, Eutroxsig, Levoxine, Levothyroxine Lup, APO-Levothyroxine, Thyrox or Levothyroxine Sandoz on a dose to dose basis, and dose titration may be required.</p>","Y","N","N","null","null","N","2023-11-01","N","4708"
"31254_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form levothyroxine sodium 100 microgram tablet, 200 (Eutroxsig, Oroxine, Levothyroxine Lup, APO-Levothyroxine and Levothyroxine Sandoz brands) and pharmaceutical benefits that have the form levothyroxine sodium 100 microgram tablet, 2 x 100 (Levoxine and Thyrox brands) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2023-11-01","N","4708"
"31255_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form levothyroxine sodium 200 microgram tablet, 200 (Eutroxsig, Oroxine, Levothyroxine Lup, APO-Levothyroxine and Levothyroxine Sandoz brands) and pharmaceutical benefits that have the form levothyroxine sodium 200 microgram tablet, 2 x 100 (Levoxine and Thyrox brands) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2023-11-01","N","4708"
"31256_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form levothyroxine sodium 50 microgram tablet, 200 (Eutroxsig, Oroxine, Levothyroxine Lup, APO-Levothyroxine and Levothyroxine Sandoz brands) and pharmaceutical benefits that have the form levothyroxine sodium 50 microgram tablet, 2 x 100 (Levoxine and Thyrox brands) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2023-11-01","N","4708"
"31257_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form levothyroxine sodium 75 microgram tablet, 200 (Eutroxsig, Oroxine, Levothyroxine Lup, APO-Levothyroxine and Levothyroxine Sandoz brands) and pharmaceutical benefits that have the form levothyroxine sodium 75 microgram tablet, 2 x 100 (Levoxine and Thyrox brands) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2023-11-01","N","4708"
"31279_N","null","null","null","null","null","<p align=""justify"">Definitions:</p><p align=""justify"">Class 5 - Pathogenic</p><p align=""justify"">Class 4 - Likely pathogenic</p><p align=""justify"">Tier I - variants of strong clinical significance</p><p align=""justify"">Tier II - variants of potential clinical significance</p>","Y","N","N","null","null","N","2024-01-01","N","4708"
"31329_N","null","null","null","null","null","<p align=""justify""><b>SEVERE CROHN DISEASE - TREATMENT PHASES AND CYCLES</b></p><p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of benefits that contain the words: &apos;severe Crohn disease&apos; in the stated PBS indication. Some of these benefits are not biological medicines, but are small molecules (e.g. a Janus-kinase inhibitor). Where the term &apos;biological medicine&apos; appears in the restriction, it includes such benefits for PBS administrative purposes.</p><p align=""justify"">A patient is eligible for PBS-subsidised treatment with only one PBS-subsidised biological medicine at any one time.</p><p align=""justify"">Treatment cycle:</p><p align=""justify"">A treatment cycle begins when an authority application is approved under an Initial 1 or Initial 3 type restriction. Once commenced, where biological medicine fails to provide the patient with an adequate response on 3 occasions, the current treatment cycle ends and there must be an absence of PBS-subsidy for a period of 5 years. The 5 year break is measured from the date of the last approval for PBS-subsidised biological medicine treatment in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">An exception to this 5 year break clause applies where:</p><p align=""justify"">(i) since the commencement of the break, an additional biological medicine has since become PBS-listed with a different pharmacological mechanism of action (i.e. the newly listed biological medicine) relative to those available on the PBS at the time of commencing the 5 year break; and</p><p align=""justify"">(ii) the patient has never been prescribed the newly listed biological medicine; and</p><p align=""justify"">(iii) the prescribed biological medicine is the newly listed biological medicine.</p><p align=""justify"">Prescribing of the newly listed biological medicine is to occur through the &apos;Initial 2&apos; treatment phase listing and the patient will not be in a new treatment cycle (i.e. where this newly listed biological medicine fails to provide an adequate response, the current treatment cycle ends and there must be an absence of PBS-subsidised biological medicine for a period of 5 years unless the exception outlined above is triggered again).</p><p align=""justify"">Within the same treatment cycle, the same PBS-subsidised biological medicine cannot continue to be subsidised where it has resulted in an inadequate response. An inadequate response is one which does not meet the minimum improvements in disease measures stated in the Continuing treatment restriction. A serious adverse reaction leading to treatment discontinuation will be exempted from being counted as an inadequate response.</p><p align=""justify"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""justify"">Treatment phases:</p><p align=""justify"">(a) Initial 1</p><p align=""justify"">Apply through this treatment phase where the patient has never been treated with PBS-subsidised biological medicine for this indication.</p><p align=""justify"">(b) Initial 2</p><p align=""justify"">Apply through this treatment phase where the prescribed treatment is changing (other than dose/form), or, where there has been a break in therapy of less than 5 years and treatment is resuming; authority applications through this treatment phase do not require prior response to conventional therapies to be re-established and do not require baseline disease activity to be re-demonstrated. An assessment of response to the preceding supply must be provided - where it is not, it will be assumed that the preceding supply provided an inadequate response.</p><p align=""justify"">(c) Initial 3</p><p align=""justify"">Apply through this treatment phase where treatment is resuming after an absence of PBS-subsidy for at least 5 years; authority applications through this treatment phase do not require a re-trial of conventional therapies.</p><p align=""justify"">(d) Continuing treatment</p><p align=""justify"">Apply through this treatment phase where an adequate response to the preceding supply is observed (or where the dose is increasing where multiple strengths exist). It is recommended that a patient be reviewed in the 4 weeks prior to exhausting the current supply to ensure uninterrupted supply. Continuing treatment authority applications are not to be made on the same day as Initial treatment authority applications.</p><p align=""justify"">(e) Balance of supply</p><p align=""justify"">Apply through this type of treatment phase only where the benefit was not requested in the full amount available in the preceding supply - this may be because the maximum quantity was not prescribed and/or the full number of repeat prescriptions was not prescribed. The intent of this treatment phase listing is to: (i) provide the balance of what could have been obtained had the full quantity and number of repeats been prescribed in the preceding authority application, (ii) allow further time for an adequate response to treatment to be demonstrated where it may not have already, and (iii) provide more immediate access to PBS-subsidy via a telephone/online authority application relative to an &apos;in-writing only&apos; application where the preceding supply was obtained through such.</p>","Y","N","N","null","null","N","2023-12-01","N","4708"
"31333_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form ceftriaxone 2 g injection, 5 vials and pharmaceutical benefits that have the form ceftriaxone 2 g injection, 10 vials are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2023-12-01","N","4708"
"31402_C","null","null","null","null","null","<p align=""justify"">Careful monitoring of patients is required due to risk of developing life-threatening Cytokine Release Syndrome (CRS).</p>","N","Y","N","null","null","N","2024-02-01","N","4708"
"31407_N","null","null","null","null","null","<p align=""justify"">TREATMENT OF COMPLEX REFRACTORY FISTULISING CROHN DISEASE</p><p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines for patients with complex refractory fistulising Crohn disease. Where the term &apos;biological medicine&apos; appears in the following notes and restrictions, it refers to adalimumab, infliximab and ustekinumab only.</p><p align=""justify"">A patient is eligible for PBS-subsidised treatment with only 1 of the PBS-subsidised biological medicines for this condition at any one time.</p><p align=""justify"">From 1 April 2011, under the PBS, all patients will be able to commence a treatment cycle where they may trial PBS-subsidised adalimumab, infliximab or ustekinumab without having to experience a disease flare when swapping to the alternate agent. Under these arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with adalimumab, infliximab or ustekinumab while they continue to show a response to therapy.</p><p align=""justify"">A patient who received PBS-subsidised adalimumab, infliximab or ustekinumab treatment prior to 1 April 2011 is considered to have started their treatment cycle as of 1 April 2011.</p><p align=""justify"">Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised adalimumab, infliximab or ustekinumab more than twice.</p><p align=""justify"">Once a patient has either failed or ceased to respond to treatment for this condition 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy for this condition before they are eligible to commence the next cycle. The 5-year break is measured from the date of the last approval for PBS-subsidised adalimumab, infliximab or ustekinumab treatment in the most recent cycle to the date of the first application for initial treatment with adalimumab, infliximab or ustekinumab under the new treatment cycle.</p><p align=""justify"">A patient who has failed fewer than 3 trials of biological medicine therapy in a treatment cycle and who has a break in therapy of less than 5 years, may commence a further course of treatment within the same treatment cycle.</p><p align=""justify"">A patient who has failed 3 trials or fewer of biological medicine therapy in a treatment cycle and who has a break in therapy of more than 5 years, may commence a new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""justify"">(1) How to prescribe PBS-subsidised adalimumab, infliximab or ustekinumab therapy after 1 April 2011.</p><p align=""justify"">(a) Initial treatment.</p><p align=""justify"">Applications for initial treatment should be made where:</p><p align=""justify"">(i) a patient has received no prior PBS-subsidised adalimumab, infliximab or ustekinumab therapy in this treatment cycle and wishes to commence such therapy (Initial 1- new patient or recommencement of treatment after a break in biological medicine of more than 5 years); or</p><p align=""justify"">(ii) a patient has received prior PBS-subsidised (initial or continuing) adalimumab, infliximab or ustekinumab therapy and wishes to trial an alternate agent (Initial 2 - change or recommencement of treatment after a break in biological medicine of less than 5 years) [further details are under &apos;Swapping therapy&apos; below]; or</p><p align=""justify"">(iii) a patient wishes to recommence treatment with adalimumab, infliximab or ustekinumab following a break in PBS-subsidised therapy with that agent (Initial 2 - change or recommencement of treatment after a break in biological medicine of less than 5 years).</p><p align=""justify"">Initial treatment authorisations will be limited to provide for a maximum of 16 weeks of therapy for adalimumab and ustekinumab and 14 weeks of therapy for infliximab.</p><p align=""justify"">From 1 April 2011, a patient must be assessed for response to any course of initial PBS-subsidised treatment following a minimum of 12 weeks of therapy for adalimumab and ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab, and this assessment must be conducted no later than 4 weeks from the date that course was ceased.</p><p align=""justify"">Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p><p align=""justify"">(b) Continuing treatment.</p><p align=""justify"">Following the completion of an initial treatment course with a biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response.</p><p align=""justify"">For the first continuing treatment course of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment under the Initial 1, or Initial 2 treatment restrictions.</p><p align=""justify"">For the second and subsequent continuing courses of PBS-subsidised biological medicine treatment, it is recommended that an assessment of a patient&apos;s response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.</p><p align=""justify"">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p><p align=""justify"">(2) Swapping therapy.</p><p align=""justify"">Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap if eligible to the alternate biological medicine within the same treatment cycle.</p><p align=""justify"">A patient may trial the alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with adalimumab, infliximab or ustekinumab at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug two times within the same treatment cycle.</p><p align=""justify"">To ensure a patient receives the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment within the timeframes specified in the relevant restriction.</p><p align=""justify"">A patient who is not able to complete an initial treatment course for a biological medicine will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p><p align=""justify"">(3) Baseline measurements to determine response.</p><p align=""justify"">A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements submitted with the first authority application for adalimumab, infliximab or ustekinumab. However, prescribers may provide new baseline measurements any time that an initial treatment authority application is submitted within a treatment cycle and the eligibility for continuing treatment must be assessed according to these revised baseline measurements.</p><p align=""justify"">(4) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.</p><p align=""justify"">A patient who wishes to recommence treatment following a break in PBS-subsidised biological medicine therapy of at least 5 years, must requalify for initial treatment with respect to the indices of disease severity.</p>","Y","N","N","null","null","N","2024-01-01","N","4708"
"31446_C","null","null","null","null","null","<p align=""justify"">C5 inhibitors increase the risk of meningococcal infections (septicaemia and/or meningitis).</p><p align=""justify"">Please consult the approved PI for information about vaccination against meningococcal infection.</p>","N","Y","N","null","null","N","2024-01-01","N","4708"
"31447_N","null","null","null","null","null","<p align=""justify"">C5 inhibitors are not PBS-subsidised to treat TMA caused by conditions other than aHUS. Examples of TMA caused by conditions other than aHUS may include the following but not limited to:</p><p align=""justify"">a) Active malignancy;</p><p align=""justify"">b) Active HIV infection;</p><p align=""justify"">c) Hematopoietic stem cell transplants;</p><p align=""justify"">d) Various drugs including quinine, high-dose calcineurin inhibitors, antiplatelet agents;</p><p align=""justify"">e) Certain chemotherapy drugs or immunosuppressant drugs associated with microangiopathic haemolytic anaemia/TMA;</p><p align=""justify"">f) Active autoimmune diseases.</p><p align=""justify"">In cases where alternative causes of TMA have not been adequately excluded, additional information may be required from the prescriber to clarify the diagnosis before approval of the application.</p>","Y","N","N","null","null","N","2024-01-01","N","4708"
"31448_N","null","null","null","null","null","<p align=""justify"">Patients must be screened for genetic mutations known to confer a high risk of aHUS. These results should be submitted to Services Australia when they become available. Once the results have been submitted to Services Australia, they do not have to be resubmitted in subsequent applications.</p>","Y","N","N","null","null","N","2024-01-01","N","4708"
"31495_N","null","null","null","null","null","<p align=""justify"">Services Australia will contact the prescriber by telephone after a written application has been submitted.</p>","Y","N","N","null","null","N","2024-01-01","N","4708"
"31589_C","null","null","null","null","null","<p align=""justify"">Combination treatment with nivolumab and relatlimab is associated with an increased incidence and severity of immune-related adverse reactions compared with nivolumab monotherapy. Monitoring at least prior to each dose is recommended.</p>","N","Y","N","null","null","N","2024-02-01","N","4708"
"31677_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms filgrastim 300 microgram/0.5 mL injection, 10 x 0.5 mL syringes and filgrastim 300 microgram/0.5 mL injection, 5 x 0.5 mL syringes are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2024-03-01","N","4708"
"31678_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms filgrastim 480 microgram/0.5 mL injection, 10 x 0.5 mL syringes and filgrastim 480 microgram/0.5 mL injection, 5 x 0.5 mL syringes are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2024-03-01","N","4708"
"31703_N","null","null","null","null","null","<p align=""justify"">For item codes 13960R and 13997Q, pharmaceutical benefits that have the form tablet 20 mg (base) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2024-03-01","N","4708"
"31726_N","null","null","null","null","null","<p align=""justify"">Details of the Liverpool COVID-19 Drug interaction checker can be found at: https://www.covid19-druginteractions.org/checker</p>","Y","N","N","null","null","N","2024-03-01","N","4708"
"31763_N","null","null","null","null","null","<p align=""justify""><b>PATIENTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS - TREATMENT CYCLES AND TREATMENT PHASES</b></p><p align=""justify"">Where the term &apos;biological medicine&apos; appears in notes and restrictions, it refers to pharmaceutical benefits listed specifically for the indication of: non-radiographic axial spondyloarthritis. Some listed pharmaceutical benefits are technically not biological medicines (e.g. Janus-kinase inhibitors), but for practical purposes, have been included under the broad term of &apos;biological medicine&apos;.</p><p align=""justify"">A patient is eligible for PBS-subsidised treatment with only 1 biological medicine at any one time.</p><p align=""justify"">Treatment cycles:</p><p align=""justify"">A treatment cycle commences when the authority application for first PBS-subsidised biological medicine is approved for a given patient under the &apos;Initial 1&apos; treatment phase. The treatment cycle continues until a fourth biological medicine fails to provide the patient with an adequate response. A new treatment cycle begins each time PBS subsidy is obtained through the &apos;Initial 3&apos; treatment phase.</p><p align=""justify"">Within a treatment cycle, the same PBS-subsidised biological medicine must not be subsidised more than once where it has failed to provide the patient with an adequate response on any occasion that a response assessment is conducted.</p><p align=""justify"">Once biological medicines have failed to provide a patient with an adequate response 4 times (once with any biological medicine) within the same treatment cycle, the treatment cycle has been completed and the patient must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy before they are eligible to commence the next cycle. The 5-year break is measured from the date of the last prescription for PBS-subsidised biological medicine treatment in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">A serious adverse reaction requiring permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven&apos;s Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a completed treatment attempt.</p><p align=""justify"">Where there have been fewer than 4 inadequate responses with biological medicine therapy in a treatment cycle and there has been a break in therapy of less than 5 years, the patient may continue treatment within the same treatment cycle.</p><p align=""justify"">A patient who has had a break in therapy of more than 5 years may commence a new treatment cycle with up to 4 treatment attempts.</p><p align=""justify"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""justify"">Treatment phases:</p><p align=""justify"">(1) Initial treatment.</p><p align=""justify"">Applications for initial treatment should be made where:</p><p align=""justify"">(i) no prior PBS-subsidised biological medicine treatment has been prescribed - apply through the &apos;Initial 1 - New patient&apos; treatment phase</p><p align=""justify"">(ii) a patient has received prior PBS-subsidised (initial or continuing) biological medicine therapy, but is prescribed an alternate biological medicine - apply through the &apos;Initial 2 - Change or Recommencement of treatment after a break in therapy of less than 5 years&apos; [further details are under &apos;Changing the prescribed biological medicine&apos; below]; or</p><p align=""justify"">(iii) a patient is recommencing treatment following a break in PBS-subsidised therapy of less than 5 years - apply through the &apos;Initial 2 - Change or Recommencement of treatment after a break in therapy of less than 5 years&apos; treatment phase (note that where there is both a change and recommencement after less than 5 years occurring simultaneously, Initial 2 is the correct treatment phase to apply through); or</p><p align=""justify"">(iv) a patient is recommencing treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years - apply through the &apos;Initial 3 - Recommencement of treatment after a break in biological medicine of more than 5 years&apos; treatment phase.</p><p align=""justify"">A patient must be assessed for response to a course of initial PBS-subsidised treatment following a minimum of 12 weeks of therapy.</p><p align=""justify"">(2) Continuing treatment.</p><p align=""justify"">For continuing PBS subsidy of biological medicine it is recommended that a patient be reviewed the month prior to when the continuing dose is due to ensure uninterrupted biological medicine supply.</p><p align=""justify"">Continuing PBS subsidy is available in quantities/repeats that provide up to 24 weeks of continuing treatment where an adequate response to the immediately preceding supply of treatment has been experienced.</p><p align=""justify"">A patient must be assessed for response to a course of continuing therapy, and the assessment must be conducted no later than 4 weeks from the cessation of that treatment course. Where a response assessment is not conducted within the required timeframe, the treatment will be deemed to have failed to provide an adequate response, unless the patient has experienced a serious adverse reaction requiring permanent treatment withdrawal.</p><p align=""justify"">(3) Changing the prescribed biological medicine.</p><p align=""justify"">Once initial treatment with the first PBS-subsidised biological medicine is approved, an alternate biological medicine may be prescribed within the same treatment cycle without having to requalify with respect to the indices of disease severity (i.e. the C-reactive protein (CRP) level and the BASDAI score), or the prior NSAID therapy and exercise program requirements. An authority application must be made under the &apos;Initial 2&apos; treatment phase and must indicate the response to the preceding biological medicine in terms of whether the response was adequate or not. The prescription for the discontinued biological medicine must be marked as cancelled by the prescriber.</p><p align=""justify"">(4) Baseline measurements to determine response.</p><p align=""justify"">A response to treatment is based on the baseline BASDAI score and CRP level documented in the patient&apos;s medical records.</p><p align=""justify"">For a patient untreated with biological medicines, the BASDAI score used to determine baseline disease severity must be measured while the patient is receiving NSAID therapy and completing their exercise program.</p><p align=""justify"">To ensure consistency in determining response, the same indices of disease severity used to establish baseline must be used for all subsequent continuing treatment applications.</p><p align=""justify"">Prescribers may provide new baseline measurements any time that an &apos;Initial treatment&apos; authority application is submitted and the eligibility for continuing treatment must be assessed according to these revised baseline measurements.</p><p align=""justify"">(5) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.</p><p align=""justify"">A second or subsequent course of treatment following a break in PBS-subsidised biological medicine therapy of at least 5 years, must occur through the Initial 3 treatment restriction. The same clinical criteria and indices of disease severity (i.e. the C-reactive protein (CRP) levels and the BASDAI) as for the Initial 1 (New patient) restriction will need to be met, but a re-trial of NSAID therapy and exercise therapy is not required.</p><p align=""justify"">(6) Balance of Supply</p><p align=""justify"">Where the full number of repeat prescriptions have not been requested under any initial or continuing listing, apply for the balance of the supply of the repeats under any treatment phase listing containing the words &apos;balance of supply&apos;.</p>","Y","N","N","null","null","N","2024-04-01","N","4708"
"31786_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form teriparatide 250 microgram/mL injection, 2.4 mL cartridge and the pharmaceutical benefits that have the form teriparatide 250 microgram/mL injection, 2.4 mL pen device are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2024-04-01","N","4708"
"31802_N","null","null","null","null","null","<p align=""justify"">The Nottingham grading system is the histologic grading system developed by Elston and Ellis as a modification of the Scarff-Bloom-Richardson grading system. See the following literature publication for details:</p><p align=""justify"">Elston, CW, Ellis, IO. Pathological prognostic factors in breast cancer. The value of histological grade in breast cancer: experience from a large study with long-term follow-up. Histopathology. 1991 Nov;19(5):403-10.</p>","Y","N","N","null","null","N","2024-05-01","N","4708"
"31864_C","null","null","null","null","null","<p align=""justify"">The patient&apos;s condition should be assessed prior to receiving treatment and closely monitored throughout the treatment period.</p>","N","Y","N","null","null","N","2024-05-01","N","4708"
"31938_N","null","null","null","null","null","<p align=""justify"">See the following article for details on the 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS):</p><p align=""justify"">Vernon MK, Swett LL, Speck RM, et al. Psychometric validation and meaningful change thresholds of the Worst Itching Intensity Numerical Rating Scale for assessing itch in patients with chronic kidney disease-associated pruritus. J Patient Rep Outcomes. 2021;5(1):134. Published 2021 Dec 24. doi:10.1186/s41687-021-00404-z</p><p align=""justify"">The WI-NRS scale is available as downloadable document in the supplementary information section at: www.ncbi.nlm.nih.gov/pmc/articles/PMC8709801/</p>","Y","N","N","null","null","N","2024-05-01","N","4708"
"31982_C","null","null","null","null","null","<p align=""justify"">Liposomal daunorubicin and cytarabine (Vyxeos) must not be substituted or interchanged with other daunorubicin and/or cytarabine containing products. Due to substantial differences in the pharmacokinetic parameters, the dose and schedule recommendations for Vyxeos are different from other medications that contain daunorubicin and/or cytarabine in other forms.</p>","N","Y","N","null","null","N","2024-07-01","N","4708"
"32001_N","null","null","null","null","null","<p align=""justify"">Definition:</p><p align=""justify"">A HbA1c measurement greater than 7% despite treatment with the specified prior therapy/therapies indicates inadequate responsiveness. Where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2-week period indicates inadequate responsiveness.</p><p align=""justify"">Blood glucose monitoring is an alternative to HbA1c measurement where at least one of the following circumstances applies:</p><p align=""justify"">(a) A clinical condition with reduced red blood cell survival (inclusive of haemolytic anaemias, haemoglobinopathies),</p><p align=""justify"">(b) Red cell transfusion within the previous 3 months.</p><p align=""justify"">Document HbA1c measurements (blood glucose measurements where relevant), as well as any intolerances/contraindications in the patient&apos;s medical records.</p>","Y","N","N","null","null","N","2024-06-01","N","4708"
"32002_N","null","null","null","null","null","<p align=""justify"">Abbreviations used in the restriction are as follows:</p><p align=""justify"">SGLT2 - sodium glucose co-transporter-2 inhibitor (drug names ending in &apos;flozin&apos;)</p><p align=""justify"">DPP4 - dipeptidyl peptidase-4 inhibitor (drug names ending in &apos;gliptin&apos;)</p><p align=""justify"">GLP-1 - glucagon-like peptide-1 receptor agonist</p>","Y","N","N","null","null","N","2024-06-01","N","4708"
"32006_N","null","null","null","null","null","<p align=""justify"">For the purposes of this restriction, the list of gating mutations are: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.</p>","Y","N","N","null","null","N","2024-06-01","N","4708"
"32112_N","null","null","null","null","null","<p align=""justify"">Authority applications for increased repeats (where relevant) may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone to Services Australia on 1800 888 333.</p>","Y","N","N","null","null","N","2024-06-01","N","4708"
"32128_N","null","null","null","null","null","<p align=""justify"">Patients may qualify for PBS-subsidised treatment under this restriction once only.</p>","Y","N","N","null","null","N","2024-07-01","N","4708"
"32371_N","null","null","null","null","null","<p align=""justify"">The Karnofsky Performance Score is available at:</p><p align=""justify"">https://oncologypro.esmo.org/oncology-in-practice/practice-tools/performance-scales</p><p align=""justify"">www.mdcalc.com/calc/3168/karnofsky-performance-status-scale</p>","Y","N","N","null","null","N","2024-08-01","N","4708"
"32372_N","null","null","null","null","null","<p align=""justify"">The Lansky Performance Score is available at:</p><p align=""justify"">www.mdcalc.com/calc/3176/lansky-play-performace-scale-pediatric-functional-status</p>","Y","N","N","null","null","N","2024-08-01","N","4708"
"32503_N","null","null","null","null","null","<p align=""justify"">Vascular endothelial growth factor (VEGF)-targeted tyrosine kinase inhibitor&apos;s (TKI) include: lenvatinib.</p>","Y","N","N","null","null","N","2024-08-01","N","4708"
"32592_N","null","null","null","null","null","<p align=""justify"">For Optometrists, prescribe in accordance with Optometry Board of Australia guidelines.</p>","Y","N","N","null","null","N","2024-09-01","N","4708"
"32663_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF ADULT PATIENTS WITH SEVERE PSORIATIC ARTHRITIS</b></p><p align=""justify"">The following information applies to Pharmaceutical Benefits Scheme (PBS) listed for adult patients with severe psoriatic arthritis.</p><p align=""justify"">Where the term &apos;biological medicine&apos; appears in notes and restrictions, it refers to any PBS benefit where the PBS indication specifies: Severe Psoriatic Arthritis. Some benefits are not biological medicines, but are small molecules. However, for administrative purposes, these benefits are included within the term &apos;biological medicine&apos;.</p><p align=""justify"">A patient is eligible for PBS-subsidised treatment with only 1 of the biological medicines at any one time.</p><p align=""justify"">Under these arrangements, within a single treatment cycle, a patient may receive long-term treatment with a biological medicine as long as they sustain a response to therapy.</p><p align=""justify"">A patient who received PBS-subsidised adalimumab, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, secukinumab, tofacitinib or ustekinumab treatment prior to 1 October 2021 is considered to start their first cycle as of 1 October 2021.</p><p align=""justify"">Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once.</p><p align=""justify"">Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven&apos;s Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.</p><p align=""justify"">Once a patient has either failed or ceased to sustain a response to treatment 3 times, they are deemed to have completed a single cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy before they are eligible to commence another cycle.</p><p align=""justify"">The duration of the break in therapy will be measured from the date the last prescription for PBS-subsidised treatment was approved in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""justify"">How to prescribe PBS-subsidised biological medicine treatment for severe psoriatic arthritis.</p><p align=""justify"">(1) Initial treatment.</p><p align=""justify"">Applications for initial treatment should be made where:</p><p align=""justify"">(i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy (Initial 1 - New patient); or,</p><p align=""justify"">(ii) a patient has received prior PBS-subsidised biological medicine therapy (initial or continuing) and wishes to trial an alternate medicine (Initial 2 - Change or Recommencement of treatment after a break in therapy of less than 5 years) [further details are under &apos;Swapping therapy&apos; below]; or,</p><p align=""justify"">(iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 5 years with the same medicine (Initial 2 - Change or Recommencement of treatment after a break in biological medicine of less than 5 years).</p><p align=""justify"">(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 3 - Recommencement of treatment after a break in biological medicine of more than 5 years).</p><p align=""justify"">A patient must be assessed for response to a course of PBS-subsidised initial treatment following a minimum of 12 weeks of therapy and conducted no later than 4 weeks from the cessation of the treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment.</p><p align=""justify"">(2) Continuing treatment.</p><p align=""justify"">Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response. It is recommended that a patient be reviewed for response following a minimum of 12 weeks of therapy and no later than the 4 weeks from the completion of the most recent course of treatment.</p><p align=""justify"">A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to Services Australia where applicable. Where a response assessment is not submitted where applicable, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p><p align=""justify"">(3) Swapping therapy.</p><p align=""justify"">Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine without having to re-qualify with respect to either the indices of disease severity (i.e. erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) level, and active joint count) or the prior non-biological therapy requirements. An authority application must be made under the &apos;Initial 2&apos; treatment phase.</p><p align=""justify"">A patient who is not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p><p align=""justify"">A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application.</p><p align=""justify"">However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug within the same treatment cycle.</p><p align=""justify"">(4) Baseline measurements to determine response.</p><p align=""justify"">A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements of the indices of disease severity submitted with the first authority application for a biological medicine. However, prescribers may provide new baseline measurements any time that an initial or change or recommencement treatment application is submitted within a treatment cycle and these revised baseline measurements will be used to assess response to the PBS-subsidised treatment.</p><p align=""justify"">To ensure consistency in determining response, the same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments. Therefore, where only an ESR or CRP level is provided at baseline, an ESR or CRP level respectively must be used to determine response. Similarly, where the baseline active joint count is based on total active joints (i.e. 20 or more active joints), response will be determined according to a reduction in the total number of active joints.</p><p align=""justify"">(5) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.</p><p align=""justify"">A patient who wishes to trial a second or subsequent course of treatment following a break in PBS-subsidised biological therapy of at least 5 years, must qualify under Initial 3 treatment restriction according to the criteria of the relevant restriction and index of disease severity. The application must include a joint count and ESR and/or CRP measurement that is no more than 4 weeks old at the time of application.</p>","Y","N","N","null","null","N","2024-10-01","N","4708"
"32715_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg tablet, tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg tablet, and tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg tablet are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2024-10-01","N","4708"
"32789_N","null","null","null","null","null","<p align=""justify"">Estradiol should be used in conjunction with progestogen in women with an intact uterus.</p>","Y","N","N","null","null","N","2024-11-01","N","4708"
"32791_N","null","null","null","null","null","<p align=""justify"">The ALS Functional Rating Scale - Revised (ALSFRS-R) can be accessed online at:</p><p align=""justify"">www.mdcalc.com/calc/10166/revised-amyotrophic-lateral-sclerosis-functional-rating-scale-alsfrs-r or https://neurotoolkit.com/alsfrs-r/</p>","Y","N","N","null","null","N","2025-03-01","N","4708"
"32881_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form choriogonadotropin alfa solution for injection 250 micrograms in 0.5 mL pre-filled syringe (Ovidrel USA) can be substituted for choriogonadotropin alfa solution for injection 250 micrograms in 0.5 mL pre-filled pen in the case of a shortage.</p>","Y","N","N","null","null","N","2024-11-01","N","4708"
"33019_N","null","null","null","null","null","<p align=""left"">Only one prescribed amount can be used for dispensing and claiming purposes. For daunorubicin with cytarabine (Vyxeos), daunorubicin has been selected as the primary ingredient and the maximum amount reflects the maximum amount of daunorubicin only. The prescribed amount of daunorubicin will be used to determine the number of vials needed.</p>","Y","N","N","null","null","N","2024-12-01","N","4708"
"33022_N","null","null","null","null","null","<p align=""left"">Only one prescribed amount can be used for dispensing and claiming purposes. For nivolumab with relatlimab (Opdualag), nivolumab has been selected as the primary ingredient and the maximum amount reflects the maximum amount of nivolumab only. The prescribed amount of nivolumab will be used to determine the number of vials needed.</p>","Y","N","N","null","null","N","2024-12-01","N","4708"
"33025_N","null","null","null","null","null","<p align=""justify"">In accordance with the Therapeutic Goods Administration (TGA)-approved Product Information, this PBS listing currently intends for once daily dosing only with PBS treatment. Divided dosing of PBS treatment is not intended (e.g. 18 mg in the mornings, 36 mg in the evenings). Where applications (either on the same day or on separate days) for multiple strengths are sought with an intent to titrate patient&apos;s dosage, repeats should only be sought for the listed target strength</p>","Y","N","N","null","null","N","2024-12-01","N","4708"
"33040_N","null","null","null","null","null","<p align=""justify"">In accordance with the Therapeutic Goods Administration (TGA)-approved Product Information, this PBS listing currently intends for once daily dosing only with PBS treatment. Divided dosing of PBS treatment is not intended (e.g. 20 mg in the mornings, 30 mg in the evenings). Where applications (either on the same day or on separate days) for multiple strengths are sought with an intent to titrate patient&apos;s dosage, repeats should only be sought for the listed target strength</p>","Y","N","N","null","null","N","2024-12-01","N","4708"
"33044_N","null","null","null","null","null","<p align=""justify"">Continuing treatment with elotuzumab is only available through the Pharmaceutical Benefits Scheme (PBS) for existing eligible patients from 1 December 2024.</p>","Y","N","N","null","null","N","2024-12-01","N","4708"
"33077_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF PATIENTS WITH SEVERE ACTIVE JUVENILE IDIOPATHIC ARTHRITIS</b></p><p align=""justify"">The following information applies to Pharmaceutical Benefits Scheme (PBS) benefits listed with the indication of severe active juvenile idiopathic arthritis.</p><p align=""justify"">Where the term &apos;biological medicine&apos; appears in notes and restrictions, it refers to any PBS benefit where the PBS indication specifies: Severe active juvenile idiopathic arthritis. Some benefits are not biological medicines, but are small molecules. However, for administrative purposes, these benefits are included within the term &quot;biological medicine&quot;.</p><p align=""justify"">Treatment cycles:</p><p align=""justify"">From 1 December 2023, a patient receiving PBS-subsidised biological medicine is considered to be in a treatment cycle where they may switch to an alternate biological medicine without having to experience a disease flare. Under these interchangeability arrangements, within a single treatment cycle, a patient may:</p><p align=""justify"">(i) continue to receive long-term treatment with a PBS-subsidised biological medicine while they continue to show a response to therapy; and</p><p align=""justify"">(ii) fail to respond or to sustain a response to each PBS-subsidised biological medicine once only. Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment.</p><p align=""justify"">Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven&apos;s Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.</p><p align=""justify"">Where treatment has resulted in an inadequate response on 3 occasions a treatment cycle is considered to have been completed and there must be a 12-month break in PBS-subsidy from all biological medicines with the PBS indication &apos;severe active juvenile idiopathic arthritis&apos; before starting a new treatment cycle.</p><p align=""justify"">The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised biological medicine was prescribed to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">A patient who received PBS-subsidised biological medicine immediately prior to 1 December 2023 is considered to be in their first cycle as of 1 December 2023. A patient who has had a break in biological medicine treatment of at least 12 months immediately prior to making a new application, on or after 1 December 2023, will commence a new treatment cycle under the Initial 3 treatment restriction.</p><p align=""justify"">Where treatment has resulted in an inadequate response on fewer than 3 occasions in a treatment cycle and where a break in therapy of less than 12 months has occurred a further course of treatment may be commenced within the same treatment cycle.</p><p align=""justify"">Where treatment has resulted in an inadequate response on fewer than 3 occasions in a treatment cycle and where a break in therapy of more than 12 months has occurred a new treatment cycle must be commenced.</p><p align=""justify"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""justify"">Prescribing under the correct &apos;Treatment Phase&apos; listing for the authority application:</p><p align=""justify"">(1) Initial treatment.</p><p align=""justify"">Apply under the &apos;Initial 1&apos; treatment listing where the patient has never received a biological medicine for &apos;severe active juvenile idiopathic arthritis&apos;.</p><p align=""justify"">(2) Continuing treatment.</p><p align=""justify"">Apply under the &apos;Continuing treatment&apos; listing where the patient is experiencing an adequate response as defined in the restriction where there has been no change in prescribed biological medicine. Under no circumstance is continuing treatment to precede initial treatment. An authority application for continuing treatment is not to be made on the same day as initial treatment.</p><p align=""justify"">(3) Changing therapy.</p><p align=""justify"">Apply under the &apos;Initial 2&apos; treatment listing. The indices of disease severity (joint count) or the prior non-biological medicine therapy requirements will not need to be restated, except if the patient has had a break in therapy of more than 12 months who would then need to requalify under the initial 3 restrictions with respect to the indices of disease severity.</p><p align=""justify"">A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application.</p><p align=""justify"">However, they cannot change to a particular biological medicine if it has failed to provide the patient with an adequate response within the same treatment cycle. A response assessment to the preceding supply of biological medicine must accompany the initial 2 authority application.</p><p align=""justify"">(4) Baseline measurements to determine response.</p><p align=""justify"">A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements of the joint count provided with the first authority application for a biological medicine. However, prescribers may provide a new baseline measurement any time that an initial treatment authority application is provided within a treatment cycle and the eligibility for continuing treatment should be assessed according to the revised baseline measurement.</p><p align=""justify"">(5) Recommencement of treatment after a 12-month break in PBS-subsidised therapy.</p><p align=""justify"">Apply under the &apos;Initial 3&apos; treatment listing.</p><p align=""justify"">(6) Withdrawal of treatment after sustained remission.</p><p align=""justify"">Withdrawal of treatment with biological medicine should be considered in a patient who has achieved and sustained complete remission of disease for 12 months. An assessment of demonstration of response to the current treatment should be conducted at the time treatment is ceased and the results retained in the patient&apos;s records. These results must be provided to Services Australia if subsequent authority applications are required.</p>","Y","N","N","null","null","N","2025-01-01","N","4708"
"33079_C","null","null","null","null","null","<p align=""justify"">The following should be assessed prior to receiving treatment and closely monitored throughout the treatment period:</p><p align=""justify"">1. QTc prolongation via an electrocardiogram</p><p align=""justify"">2. Hypocortisolism</p><p align=""justify"">3. Corticotroph tumour growth</p>","N","Y","N","null","null","N","2025-02-05","N","4708"
"33080_N","null","null","null","null","null","<p align=""justify"">Cortisol levels should be monitored at regular intervals, since hypocortisolism-related events can occur at any time during treatment.</p>","Y","N","N","null","null","N","2025-02-05","N","4708"
"33124_N","null","null","null","null","null","<p align=""justify"">Dabrafenib is available as capsules and dispersible tablets. Caution is advised when consideration is given to changing formulations as the formulations are not bioequivalent. Frequent switching between formulations is discouraged.</p>","Y","N","N","null","null","N","2025-03-01","N","4708"
"33164_N","null","null","null","null","null","<p align=""justify""><b>Biosimilar prescribing policy</b></p><p align=""justify"">Prescribing of a biosimilar brand where available is encouraged for treatment naive patients.</p>","Y","N","N","null","null","N","2025-01-01","N","4708"
"33185_N","null","null","null","null","null","<p align=""justify"">An appropriate amount of drug (maximum quantity in units) for this treatment phase listing per prescription, where only one of the two strengths is prescribed at any given time, is outlined below:</p><p align=""justify"">10 mg strength presentation:</p><p align=""justify"">Below 13 kg: up to 3 units</p><p align=""justify"">13 to 16 kg: up to 4 units</p><p align=""justify"">16 to 21 kg: up to 5 units</p><p align=""justify"">21 to 25 kg: up to 8 units</p><p align=""justify"">15 mg strength presentation:</p><p align=""justify"">Below 19 kg: up to 3 units</p><p align=""justify"">19 to 24 kg: up to 4 units</p><p align=""justify"">24 to 32 kg: up to 5 units</p><p align=""justify"">32 to 47 kg: up to 8 units</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"33186_N","null","null","null","null","null","<p align=""justify"">Trametinib is available as tablets and oral solution. Caution is advised when consideration is given to changing formulations as the formulations are not bioequivalent. Frequent switching between formulations is discouraged.</p>","Y","N","N","null","null","N","2025-03-01","N","4708"
"33187_N","null","null","null","null","null","<p align=""justify"">An appropriate amount of drug (maximum quantity in units) for this treatment phase listing per prescription, where only one of the two strengths is prescribed at any given time, is outlined below:</p><p align=""justify"">10 mg strength presentation:</p><p align=""justify"">Below 10 kg: up to 2 units</p><p align=""justify"">10 to 16 kg: up to 3 units</p><p align=""justify"">16 to 21 kg: up to 4 units</p><p align=""justify"">21 to 25 kg: up to 6 units</p><p align=""justify"">15 mg strength presentation:</p><p align=""justify"">Below 16 kg: up to 2 units</p><p align=""justify"">16 to 24 kg: up to 3 units</p><p align=""justify"">24 to 32 kg: up to 4 units</p><p align=""justify"">32 to 47 kg: up to 6 units</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"33205_C","null","null","null","null","null","<p align=""justify"">Ryeqo should not be used interchangeably with GnRH agonists and/or hormonal contraceptives brands due to differences in dose and schedule of treatment.</p>","N","Y","N","null","null","N","2025-05-01","N","4708"
"33221_C","null","null","null","null","null","<p align=""justify"">If prescribed for sepsis (or suspected sepsis) by an authorised PBS prescriber who is not a medical practitioner, the decision to prescribe this benefit is to be shared with a medical practitioner.</p>","N","Y","N","null","null","N","2025-02-01","N","4708"
"33229_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form faricimab 6 mg/0.05 mL injection vial and pharmaceutical benefits that have the form faricimab 6 mg/0.05 mL injection syringe are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2025-05-01","N","4708"
"33254_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form ursodeoxycholic acid 500 mg capsule and pharmaceutical benefits that have the form ursodeoxycholic acid 500 mg tablet are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2025-02-05","N","4708"
"33272_N","null","null","null","null","null","<p align=""justify"">Cardiac monitoring must be carried out in accordance with the approved Product Information while on treatment with this drug for this condition.</p>","Y","N","N","null","null","N","2025-05-01","N","4708"
"33309_N","null","null","null","null","null","<p align=""justify"">Monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) medications are evolocumab.</p>","Y","N","N","null","null","N","2025-02-05","N","4708"
"33338_N","null","null","null","null","null","<p align=""justify"">The in-use shelf life of this product is 6 months from the date of opening</p>","Y","N","N","null","null","N","2025-04-01","N","4708"
"33339_N","null","null","null","null","null","<p align=""justify"">The in-use shelf life of this product is 3 months from the date of opening.</p>","Y","N","N","null","null","N","2025-04-01","N","4708"
"33341_C","null","null","null","null","null","<p align=""justify"">Ivosidenib can cause dose-dependent prolongation of the heart rate-corrected QT (QTc) interval. At treatment initiation patients should undergo an electrocardiogram (ECG) to assess the heart rate-corrected QT (QTc) interval. Dose interruptions are recommended until QTc returns to no more than 480 msec. Monitor ECGs at least weekly for two weeks following return of QTc. Permanently discontinue ivosidenib if QTc poses life threatening ventricular arrhythmia (Grade 4).</p>","N","Y","N","null","null","N","2025-07-01","N","4708"
"33364_N","null","null","null","null","null","<p align=""justify"">A patient may only qualify for PBS-subsidised treatment under this restriction twice in a lifetime. Patients reinitiating PBS-subsidised treatment following pregnancy are exempt from this rule.</p>","Y","N","N","null","null","N","2025-04-01","N","4708"
"33369_N","null","null","null","null","null","<p align=""justify"">Treatment should be limited to a maximum of 15 g per week.</p>","Y","N","N","null","null","N","2025-05-01","N","4708"
"33370_N","null","null","null","null","null","<p align=""justify"">This preparation is only suitable for small areas of affected skin.</p>","Y","N","N","null","null","N","2025-05-01","N","4708"
"33399_C","null","null","null","null","null","<p align=""justify"">When administering tislelizumab in combination with chemotherapy, administer tislelizumab before chemotherapy when both are given on the same day.</p>","N","Y","N","null","null","N","2025-04-01","N","4708"
"33429_N","null","null","null","null","null","<p align=""justify"">See the following article/website for details on Expanded Disability Status Scale (EDSS): https://www.ncbi.nlm.nih.gov/books/NBK222389/.</p>","Y","N","N","null","null","N","2025-04-01","N","4708"
"33487_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the brand Prazosin Hydrochloride Capsules, USP 1 mg (Novitium Pharma, USA) can be substituted for APO-Prazosin and Minipress in the case of a shortage.</p>","Y","N","N","null","null","N","2025-05-01","N","4708"
"33521_N","null","null","null","null","null","<p align=""justify"">Patient dosage is to be determined as per the Therapeutic Goods Administration (TGA) approved Product Information.</p>","Y","N","N","null","null","N","2025-05-01","N","4708"
"33586_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form aflibercept 8 mg/0.07 mL injection syringe and pharmaceutical benefits that have the form aflibercept 8 mg/0.07 mL injection vial are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2025-06-01","N","4708"
"33680_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form dupilumab injection 300 mg/2 mL, 2 x 2 mL syringes and pharmaceutical benefits that have the form dupilumab injection 300 mg/2 mL, 2 x 2 mL pen devices are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2025-09-01","N","4708"
"33698_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form methylphenidate hydrochloride modified release tablet can be substituted for Concerta (Switzerland) in the case of a shortage</p>","Y","N","N","null","null","N","2025-07-01","N","4708"
"33720_N","null","null","null","null","null","<p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","Y","N","Y","null","null","N","2025-07-01","N","4708"
"33728_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form drospirenone 4 mg tablet [24] (&amp;) inert substance tablet [4], 4 x 28 and pharmaceutical benefits that have the form drospirenone 4 mg tablet [24] (&amp;) inert substance tablet [4], 28 are equivalent for the purposes of substitution when the maximum quantity of 4 x 28 tablets is dispensed.</p>","Y","N","N","null","null","N","2025-07-01","N","4708"
"33771_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form drospirenone 3 mg + ethinylestradiol 20 microgram tablet [24] (&amp;) inert substance tablet [4], 28 are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2025-08-01","N","4708"
"33772_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form drospirenone 3 mg + ethinylestradiol 20 microgram tablet [24] (&amp;) inert substance tablet [4], 3 x 28 are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2025-08-01","N","4708"
"33773_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF PAEDIATRIC PATIENTS WITH UNCONTROLLED SEVERE ASTHMA AND UNCONTROLLED SEVERE ALLERGIC ASTHMA</b></p><p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines dupilumab for uncontrolled severe asthma and omalizumab for uncontrolled severe allergic asthma. Therefore, where the term &apos;biological medicine&apos; appears in notes and restrictions, it refers to dupilumab and omalizumab only.</p><p align=""justify"">A patient is eligible for PBS-subsidised treatment with only 1 of the above biological medicine at any one time.</p><p align=""justify"">A patient receiving PBS-subsidised treatment for uncontrolled severe asthma or uncontrolled severe allergic asthma is able to commence a treatment cycle where they may trial a biological medicine without having to experience a disease flare when swapping to an alternate biological medicine within the same treatment cycle.</p><p align=""justify"">Under these arrangements, within a treatment cycle, a patient may receive long-term treatment with a biological medicine as long as they sustain a response to therapy.</p><p align=""justify"">A patient currently receiving PBS-subsidised treatment as of 1 September 2025 is considered to have started a cycle of treatment.</p><p align=""justify"">Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to the same PBS-subsidised biological medicine more than once.</p><p align=""justify"">Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment.</p><p align=""justify"">Once a patient has either failed to achieve or sustain a response to treatment 2 times, they are deemed to have completed a single treatment cycle. They must have at least a 12-month break in PBS-subsidised biological medicine therapy before they are eligible to recommence another new treatment cycle [further details are under &apos;Recommencement of treatment after a break in PBS-subsidised therapy&apos; below].</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine is ceased until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">How to prescribe PBS-subsidised biological medicine treatment for uncontrolled severe asthma/uncontrolled severe allergic asthma.</p><p align=""justify"">(1) Initial treatment:</p><p align=""justify"">Applications for initial treatment should be made where:</p><p align=""justify"">(i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy (Initial 1 restriction); or</p><p align=""justify"">(ii) a patient has received prior PBS-subsidised treatment with a biological medicine and wishes to recommence a new treatment cycle with this biological medicine following a treatment break in PBS-subsidised therapy (Initial 1 restriction); or</p><p align=""justify"">(iii) a patient has received prior PBS-subsidised biological medicine therapy and wishes to trial an alternate biological medicine within the same treatment cycle (Initial 2 restriction) - [further details are under &apos;Swapping therapy&apos; below].</p><p align=""justify"">All applications for initial treatment will be limited to provide for a maximum of 32 weeks of therapy of dupilumab and a maximum of 28 weeks of therapy of omalizumab. It is recommended that a patient be reviewed in the month prior to completing their course of initial treatment to ensure uninterrupted biological medicine supply.</p><p align=""justify"">(2) Continuing treatment:</p><p align=""justify"">Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that biological medicine providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response. It is recommended that a patient be reviewed the month prior to completing their current course of treatment to ensure uninterrupted biological medicine supply.</p><p align=""justify"">(3) Baseline measurements to determine response:</p><p align=""justify"">Baseline measurements of the Asthma Control Questionnaire (ACQ, ACQ-IA; 5 item version), systemic corticosteroid dose and time adjusted exacerbation rate, submitted with the Initial authority application for a biological medicine must be used to determine whether an adequate response to treatment has been achieved or sustained.</p><p align=""justify"">However, prescribers may provide new baseline measurements when a new Initial treatment authority application is submitted and these new baseline measurements may be used to assess response.</p><p align=""justify"">(4) Swapping therapy within the same treatment cycle.</p><p align=""justify"">Once initial treatment with the first PBS-subsided biological medicine is approved, a patient may swap to an alternate biological medicine at any time by qualifying under an Initial 2 restriction, provided they meet all of the restriction criteria.</p><p align=""justify"">However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug with the same treatment cycle.</p><p align=""justify"">Within the same treatment cycle a patient may alternate between therapy with either biological medicine of their choice (1 at a time) providing:</p><p align=""justify"">(i) they have not received PBS-subsided treatment with that particular biological medicine previously; or</p><p align=""justify"">(ii) they have demonstrated an adequate response to that particular biological medicine if they have previously trialled it on the PBS; and</p><p align=""justify"">(iii) they have not previously failed to respond to treatment with either 2 biological medicines in this treatment cycle.</p><p align=""justify"">(5) Re-commencement of a new treatment cycle after a treatment break in PBS-subsidised therapy:</p><p align=""justify"">A patient who wishes to trial a second or subsequent new treatment cycle, following a break in PBS-subsidised therapy of at least 12 months (in patients who have failed to achieve or ceased to sustain a response to treatment 2 times within a treatment cycle), must re-qualify through an Initial 1 restriction.</p><p align=""justify"">(6) Monitoring of patients (Omalizumab only):</p><p align=""justify"">Anaphylaxis and anaphylactoid reactions have been reported following first or subsequent administration of omalizumab (see Product Information). Patients should be monitored post-injection, and medication for the treatment of anaphylactic reactions should be available for immediate use following administration of omalizumab. Patients should be informed that such reactions are possible and prompt medical attention should be sought if allergic reactions occur.</p>","Y","N","N","null","null","N","2025-09-01","N","4708"
"33786_N","null","null","null","null","null","<p align=""justify"">It is recommended that an application for continuing treatment is submitted at the 28 week assessment, to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.</p>","Y","N","N","null","null","N","2025-09-01","N","4708"
"33828_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the brand Pegasys (Ireland) can be substituted for Pegasys in the case of a shortage.</p>","Y","N","N","null","null","N","2025-09-01","N","4708"
"33846_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form omalizumab 75 mg/0.5 mL syringe and pharmaceutical benefits that have the form omalizumab 75 mg/0.5 mL pen device are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2025-08-01","N","4708"
"33847_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form omalizumab 150 mg/mL syringe and pharmaceutical benefits that have the form omalizumab 150 mg/mL pen device are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2025-08-01","N","4708"
"33867_C","null","null","null","null","null","<p align=""justify"">The omalizumab pen device is not intended for use in children below 12 years of age. For children below 12 years of age with uncontrolled severe allergic asthma, the omalizumab syringe is the appropriate form for this population.</p>","N","Y","N","null","null","N","2025-08-01","N","4708"
"33884_N","null","null","null","null","null","<p align=""justify"">Not for use in the treatment of sclerosing cholangitis.</p>","Y","N","N","null","null","N","2025-10-01","N","4708"
"33959_N","null","null","null","null","null","<p align=""justify"">AKT pathway testing is recommended (where possible) for PIK3CA, AKT1 and PTEN gene variants.</p>","Y","N","N","null","null","N","2025-10-01","N","4708"
"33974_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF PATIENTS UNDER 18 YEARS WITH SEVERE CHRONIC PLAQUE PSORIASIS</b></p><p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines adalimumab, etanercept and ustekinumab for patients under 18 years of age with severe chronic plaque psoriasis. Therefore, where the term &apos;biological medicines&apos; appears in notes and restrictions, it refers to adalimumab, etanercept and ustekinumab only.</p><p align=""justify"">A patient is eligible for PBS-subsidised treatment with only 1 of the above biological medicines at any 1 time.</p><p align=""justify"">A patient who is receiving PBS-subsidised treatment for severe chronic plaque psoriasis is able to commence a treatment cycle where they may trial a biological medicine without having to experience a disease flare when swapping to an alternate biological medicine within the same treatment cycle.</p><p align=""justify"">Under these arrangements, within a treatment cycle, a patient may receive long-term treatment with a biological medicine as long as they sustain a response to therapy.</p><p align=""justify"">Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once.</p><p align=""justify"">Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven&apos;s Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.</p><p align=""justify"">A patient must be assessed for response to each course of treatment according to the criteria included in the relevant continuing treatment restriction.</p><p align=""justify"">Once a patient has either failed or ceased to sustain a response to treatment 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy before they are eligible to commence the next cycle.</p><p align=""justify"">The duration of the break in therapy will be measured from the date the last prescription for PBS-subsidised treatment was prescribed in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new cycle.</p><p align=""justify"">A patient who has failed fewer than 3 times in a treatment cycle and who has a break in therapy of more than 5 years may commence a new treatment cycle under Initial 3 treatment restriction.</p><p align=""justify"">A patient who has failed fewer than 3 times in a treatment cycle and who has a break in therapy of less than 5 years may commence a further course of treatment within the same treatment cycle under Initial 2 treatment restriction.</p><p align=""justify"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""justify"">There are separate restrictions for the initial and continuing treatment for psoriasis affecting the whole body, versus psoriasis affecting the face, hand and foot.</p><p align=""justify"">How to prescribe PBS-subsidised biological medicine treatment for severe chronic plaque psoriasis.</p><p align=""justify"">(i) a patient has never received PBS-subsidised biological medicine treatment for this condition and wishes to commence such therapy (Initial 1 - Biological medicine-naive patient); or</p><p align=""justify"">(ii) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 3 - Recommencement of treatment after a break in biological medicine of more than 5 years); or</p><p align=""justify"">(iii) a patient who has received prior PBS-subsidised biological medicine therapy for this condition (initial or continuing) and wishes to trial an alternate biological medicine or recommence with the same biological medicine within the same treatment cycle (Initial 2 - Change or Recommencement of treatment after a break in biological medicine of less than 5 years) [further details are under (4) &apos;Swapping therapy&apos; below]; or</p><p align=""justify"">(iv) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 5 years with the same medicine (Initial 2 - Change or Recommencement of treatment after a break in biological medicine of less than 5 years).</p><p align=""justify"">Etanercept only:</p><p align=""justify"">After completing 24-weeks of treatment with PBS-subsidised etanercept, a patient is eligible for re-treatment with etanercept within 12 months (Initial 4) due to a disease flare with psoriasis affecting the whole body if:</p><p align=""justify"">(i) there is at least a 50% change in the patients PASI score compared to the most recent response assessment following cessation of the most recent 24 weeks of PBS-subsidised etanercept; or</p><p align=""justify"">(ii) the patient has a current PASI score greater than 15</p><p align=""justify"">Etanercept only:</p><p align=""justify"">After completing 24-weeks of treatment with PBS-subsidised etanercept, a patient is eligible for re-treatment with etanercept (Initial 4) due to a disease flare with psoriasis affecting the face, hand or foot if:</p><p align=""justify"">(i) all subscores are rated moderate to severe; or</p><p align=""justify"">(ii) 2 of the three subscores are rated severe to very severe; or</p><p align=""justify"">(iii) the affected area of skin has increased by at least 50% compared to that at the time of the last assessment following cessation of the most recent 24 weeks of PBS-subsidised etanercept; or</p><p align=""justify"">(iv) the area affected is 30% or more of the face, palm of a hand or sole of a foot,</p><p align=""justify"">(2) Assessment of response to initial treatment.</p><p align=""justify"">After prescribing initial treatment with a biological medicine, a PASI assessment must be conducted after at least 12 weeks of treatment. This assessment will be used to determine eligibility for continuing treatment and must be conducted within 8 weeks of the last administered dose.</p><p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p><p align=""justify"">Adalimumab and Ustekinumab only:</p><p align=""justify"">To avoid an interruption of supply for First continuing treatment, the assessment should be submitted no later than 2 weeks prior to when the next dose (under the new authority application) is due, unless the patient is currently on a treatment break.</p><p align=""justify"">(3) Continuing treatment</p><p align=""justify"">Etanercept only:</p><p align=""justify"">Following the completion of an initial 16-week treatment course with etanercept, a patient may receive a further 8 weeks of treatment (under the &apos;Completion of course&apos; treatment phase) to complete a 24-week treatment course, providing they have demonstrated an adequate response to treatment to the initial supply.</p><p align=""justify"">A patient must be assessed for response to a course of continuing therapy, and the assessment must be documented in the patient&apos;s medical records. Where a response assessment is not conducted, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p><p align=""justify"">Adalimumab and Ustekinumab only:</p><p align=""justify"">Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks per continuing treatment course under the First continuing treatment restriction with that drug, provided they demonstrate an adequate response to treatment. The patient remains eligible to receive continuing treatment in courses of up to 24 weeks under the Subsequent continuing treatment restriction with that drug, provided they continue to sustain the response. It is recommended that a patient be reviewed 4 weeks prior to when their next dose (under a new authority application) is due to ensure uninterrupted supply, but no later than 8 weeks after the date of the last administered dose.</p><p align=""justify"">A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to Services Australia where applicable. Where a response assessment is not submitted where applicable, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p><p align=""justify"">(4) Swapping therapy.</p><p align=""justify"">Once initial treatment with the first PBS-subsidised biological medicine is prescribed, a patient may swap to an alternate biological medicine without having to requalify with respect to the prior non-biological therapy requirements. If the patient has had a break in therapy of more than 5 years, the indices of disease severity need to be met, but a re-trial of non-biological therapy is not required.</p><p align=""justify"">A patient who is not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p><p align=""justify"">A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to that biological medicine more than once within the same treatment cycle or have failed to respond to biological medicines, as an aggregate, on 3 occasions within the same treatment cycle.</p><p align=""justify"">To ensure patients receive the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment.</p><p align=""justify"">(5) Baseline measurements to determine response.</p><p align=""justify"">A response to treatment must be demonstrated based on the baseline PASI assessment provided with the first authority application for a biological medicine. However, prescribers may provide new baseline PASI assessments any time that an initial or change or recommencement treatment application is provided within a treatment cycle and this revised baseline PASI score will be used to assess the patient&apos;s response to the PBS-subsidised treatment. Where a patient is changing from treatment with etanercept to adalimumab or ustekinumab the prescriber must provide a baseline PASI measurement, as well as a PASI score demonstrating a response to treatment.</p><p align=""justify"">To ensure consistency in determining response, the same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of all continuing treatments.</p><p align=""justify"">(6A) Recommencement of treatment after a break of less than 5 years in PBS-subsidised therapy (all drugs except etanercept).</p><p align=""justify"">A patient who wishes to resume treatment following a break in PBS-subsidised therapy of less than 5 years must resume under the &apos;Initial 2&apos; treatment phase. The most recent PASI assessment demonstrating disease flare must be no more than 4 weeks old at the time of application.</p><p align=""justify"">(6B) Re-treatment (etanercept only)</p><p align=""justify"">A patient may be re-treated, in certain circumstances, with etanercept after completing a 24-week treatment course under the &apos;Initial 4&apos; treatment phase.</p><p align=""justify"">(7) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.</p><p align=""justify"">A patient who wishes to undertake a new treatment cycle following a break in PBS-subsidised biological therapy of at least 5 years, must qualify under an &apos;Initial 3&apos; treatment phase.</p>","Y","N","N","null","null","N","2025-09-01","N","4708"
"33975_N","null","null","null","null","null","<p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authorisation under this restriction should be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)</p><p align=""justify"">Alternatively, applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","Y","N","Y","null","null","N","2025-10-01","N","4708"
"34034_N","null","null","null","null","null","<p align=""justify"">At the time of authority application, medical practitioners must request the appropriate number of doses to provide sufficient drug for 16 weeks of treatment.</p><p align=""justify"">An appropriate amount of drug may require prescribing a combination of strengths. A separate authority prescription must be completed for each strength requested.</p>","Y","N","N","null","null","N","2025-09-01","N","4708"
"34050_N","null","null","null","null","null","<p align=""justify"">Laboratory readings requested in this authority application must be no older than 52 weeks, prior to starting obeticholic acid or elafibranor, whichever is used first.</p>","Y","N","N","null","null","N","2025-10-01","N","4708"
"34061_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form dupilumab injection 200 mg/1.14 mL, 2 x 1.14 mL syringes and pharmaceutical benefits that have the form dupilumab injection 200 mg/1.14 mL, 2 x 1.14 mL pen devices are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2025-09-01","N","4708"
"34062_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form rivaroxaban 15 mg capsule and rivaroxaban 15 mg tablet are equivalent for the purposes of substitution, where the pack size is the same.</p>","Y","N","N","null","null","N","2025-09-01","N","4708"
"34064_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form rivaroxaban 20 mg capsule and rivaroxaban 20 mg tablet are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2025-09-01","N","4708"
"34175_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the brand DuoResp Spiromax 200/6 powder for inhalation, 120 actuations and pharmaceutical benefits that have the brands Bufomix EASYHALER 200/6, Symbicort Turbuhaler 200/6 and Rilast TURBUHALER 200/6 powder for inhalation, 120 actuations are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2025-10-01","N","4708"
"34209_N","null","null","null","null","null","<p align=""justify"">Applications for increased maximum quantities to treat both eyes may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).</p>","Y","N","Y","null","null","N","2025-10-01","N","4708"
"34347_C","null","null","null","null","null","<p align=""justify"">Where prescribed by a non-specialist prescriber, consult with a specialist medical practitioner on matters of diagnosis, choice of immunosuppressant and monitoring of immunosuppression in the patient.</p>","N","Y","N","null","null","N","2025-11-01","N","4708"
"34458_N","null","null","null","null","null","<p align=""justify"">The recommended dose of odevixibat for initial treatment is 40 micrograms/kg/day. Improvement in pruritus and reduction of serum bile acid levels may occur gradually in some patients after initiating odevixibat therapy.</p><p align=""justify"">If an adequate clinical response has been achieved after 3 consecutive months since commencement of treatment, odevixibat should be renewed at 40 micrograms/kg/day through the continuing treatment phase.</p><p align=""justify""><b>Dose modification (where dose escalation occurs during initial treatment) </b></p><p align=""justify"">If an adequate clinical response has not been achieved after at least 1 month and up to 3 months of initial treatment, the dose may be increased to 120 micrograms/kg/day (maximum of 7,200 micrograms per day) through the dose modification treatment phase for up to a total period of 6 months from the date of treatment commencement with odevixibat.</p><p align=""justify"">If an adequate clinical response is demonstrated following the balance of up to 6 months of treatment at the higher dose of 120 micrograms/kg/day, odevixibat can be renewed at the same dose through the continuing treatment phase.</p><p align=""justify"">If a patient fails to demonstrate a response after 6 months of treatment with this drug for this condition (inclusive of initial and dose modification treatment), they will no longer be eligible to receive PBS-subsidised treatment with this drug for this condition.</p><p align=""justify""><b>Continuing treatment (where dose escalation occurs during continuing treatment)</b></p><p align=""justify"">If an adequate clinical response is unable to be maintained at the lower dose (40 micrograms/kg/day) during continuing treatment, the dose may be increased to 120 micrograms/kg/day (maximum of 7,200 micrograms per day) through the continuing treatment phase.</p><p align=""justify"">If an adequate clinical response is demonstrated at the higher dose of 120 micrograms/kg/day, odevixibat can continue to be renewed at the same dose through the continuing treatment phase.</p><p align=""justify"">Patients who are unable to demonstrate an adequate clinical response to continuing treatment at the higher dose will be ineligible for further PBS-subsidised treatment with this drug for this condition.</p><p align=""justify""><b>Recommencing treatment</b></p><p align=""justify"">Patients who have demonstrated an adequate clinical response and have ceased treatment for reasons other than a lack of response may recommence treatment through the continuing treatment phase.</p>","Y","N","N","null","null","N","2025-12-10","N","4708"
"34459_N","null","null","null","null","null","<p align=""justify"">See the following article for details of the Prucision<sup>TM</sup> ObsRO Pruritus Scale:</p><p align=""justify"">Gwaltney C, Ivanescu C, Karlsson L, Warholic N, Kjems L, Horn P. Validation of the PRUCISION instruments in pediatric patients with progressive familial intrahepatic cholestasis. <i>Adv Ther.</i> 2022;39(11):5105-5125</p><p align=""justify"">The Prucision<sup>TM</sup> ObsRO Pruritus Scale is available as a downloadable document at:</p><p align=""justify"">https://d2rkmuse97gwnh.cloudfront.net/a88aa6d6-3ca0-4362-a711-d53c45ae33ff/f5ea92bf-e36b-421c-a9fe-af77243f0e42/f5ea92bf-e36b-421c-a9fe-af77243f0e42_source__v.docx</p>","Y","N","N","null","null","N","2025-12-10","N","4708"
"34506_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF PATIENTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA</b></p><p align=""justify"">The following information applies to Pharmaceutical Benefits Scheme (PBS) benefits listed for patient with the indication of moderate to severe hidradenitis suppurativa.</p><p align=""justify"">Where the term &apos;biological medicine&apos; appears in notes and restrictions, it refers to any PBS benefit where the PBS indication specifies: Moderate to Severe Hidradenitis Suppurativa.</p><p align=""justify"">Treatment cycles:</p><p align=""justify"">Under these arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with a biological medicine while they continue to show a response to therapy. A patient who has been receiving PBS-subsidised adalimumab or secukinumab prior to 1 December 2025 is considered to start their first cycle as of 1 December 2025.</p><p align=""justify"">Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once.</p><p align=""justify"">Where treatment has resulted in an inadequate response on 3 occasions, a treatment cycle is considered to have been completed, and there must be a 5-year break in PBS subsidy from all medicines with the PBS indication &apos;moderate to severe hidradenitis suppurativa&apos; before starting a new treatment cycle.</p><p align=""justify"">Where treatment has resulted in an inadequate response on fewer than 3 occasions in a treatment cycle, and where a break in therapy of less than 5 years has occurred, a further course of treatment with another biological medicine may be commenced within the same treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""justify"">Prescribing under the correct &apos;Treatment phase&apos; listing for the authority application:</p><p align=""justify"">(1) Initial treatment.</p><p align=""justify"">Apply under the &apos;Initial 1&apos; treatment listing where the patient has never received a biological medicine for moderate to severe hidradenitis suppurativa.</p><p align=""justify"">(2) Continuing treatment.</p><p align=""justify"">Apply under the &apos;Continuing treatment&apos; listing where the patient is experiencing an adequate response as defined in the restriction where there has been no change in prescribed biological medicine. Under no circumstance is continuing treatment to proceed initial treatment. An authority application for continuing treatment is not to be made on the same day as initial treatment.</p><p align=""justify"">(3) Changing/swapping therapy.</p><p align=""justify"">Apply under the &apos;Initial 2&apos; treatment listing. Once initial treatment with the first PBS-subsidised biological medicine is prescribed, a patient may swap to an alternate biological medicine without having to requalify with respect to prior antibiotic use. A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application. However, they cannot change to a particular biological medicine if it has failed to provide the patient with an adequate response as defined in the restriction within the same treatment cycle. A response assessment to the preceding supply of biological medicine must accompany this initial 2 treatment authority application.</p><p align=""justify"">(4) Baseline measurements to determine response.</p><p align=""justify"">A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurement of abscess and inflammatory nodule (AN) count submitted with the first authority application for a biological medicine. To ensure consistency in determining response, the same indices of disease severity used to establish baseline must be used for all subsequent continuing treatment applications. Prescribers may provide new baseline measurements any time an &apos;Initial treatment&apos; authority application is submitted within a treatment cycle and the eligibility for continuing treatment must be assessed according to these revised baseline measurements.</p><p align=""justify"">(5) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.</p><p align=""justify"">Apply under the &apos;Initial 3&apos; treatment listing. Prior antibiotic courses need not be re-trialled.</p>","Y","N","N","null","null","N","2025-12-01","N","4708"
"34521_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF ADULT PATIENTS WITH ANKYLOSING SPONDYLITIS</b></p><p align=""justify"">The following information applies to Pharmaceutical Benefits Scheme (PBS) benefits listed for adult patients with the indication of ankylosing spondylitis (AS).</p><p align=""justify"">Where the term &apos;biological medicine&apos; appears in notes and restrictions, it refers to any PBS benefit where the PBS indication specifies: Ankylosing spondylitis. Some benefits are not biological medicines, but are small molecules. However, for administrative purposes, these benefits are included within the term &apos;biological medicine&apos;.</p><p align=""justify"">Treatment cycles:</p><p align=""justify"">Under these arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with a biological medicine while they continue to show a response to therapy. A patient who has been receiving PBS-subsidised adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, ixekizumab and secukinumab treatment prior to 1 October 2021 is considered to start their first cycle as of 1 October 2021.</p><p align=""justify"">Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once.</p><p align=""justify"">Where treatment has resulted in an inadequate response on 3 occasions a treatment cycle is considered to have been completed and there must be a 5-year break in PBS subsidy from all medicines with the PBS indication: &apos;Ankylosing spondylitis&apos; before starting a new treatment cycle. The 5-year break is measured from the date of the last prescription for PBS-subsidised biological medicine treatment in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">Where treatment has resulted in an inadequate response on fewer than 3 occasions in a treatment cycle and where a break in therapy of less than 5 years has occurred, a further course of treatment may be commenced within the same treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""justify"">Prescribing under the correct &apos;Treatment phase&apos; listing for the authority application:</p><p align=""justify"">(1) Initial treatment.</p><p align=""justify"">Apply under the &apos;Initial 1&apos; treatment listing where the patient has never received a biological medicine for ankylosing spondylitis.</p><p align=""justify"">(2) Continuing treatment.</p><p align=""justify"">Apply under the &apos;Continuing treatment&apos; listing where the patient is experiencing an adequate response as defined in the restriction where there has been no change in prescribed biological medicine. Under no circumstance is continuing treatment to proceed initial treatment. An authority application for continuing treatment is not to be made on the same day as initial treatment.</p><p align=""justify"">(3) Changing therapy.</p><p align=""justify"">Apply under the &apos;Initial 2&apos; treatment listing. Once initial treatment with the first PBS-subsidised biological medicine is prescribed, a patient may swap to an alternate biological medicine without having to requalify with respect to prior NSAID therapy and exercise program requirements. Where a patient is changing from a biosimilar medicine the prescriber must submit baseline indices of disease severity (i.e. the erythrocyte sedimentation rate (ESR), the C-reactive protein (CRP) levels and the BASDAI). A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application. However, they cannot change to a particular biological medicine if it has failed to provide the patient with an adequate response within the same treatment cycle. A response assessment to the preceding supply of biological medicine must accompany this initial 2 treatment authority application.</p><p align=""justify"">(4) Baseline measurements to determine response.</p><p align=""justify"">A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements of the BASDAI, ESR and/or CRP submitted with the first authority application for a biological medicine. To ensure consistency in determining response, the same indices of disease severity used to establish baseline must be used for all subsequent continuing treatment applications. Prescribers may provide new baseline measurements any time an &apos;Initial treatment&apos; authority application is submitted within a treatment cycle and the eligibility for continuing treatment must be assessed according to these revised baseline measurements.</p><p align=""justify"">(5) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.</p><p align=""justify"">Apply under the &apos;Initial 3&apos; treatment listing. Prior NSAID and exercise therapies need not be re-trialled.</p>","Y","N","N","null","null","N","2025-12-01","N","4708"
"34570_N","null","null","null","null","null","<p align=""left"">For the purposes of this restriction, PBS-subsidised &apos;CFTR modulator&apos; means ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor, elexacaftor/tezacaftor/ivacaftor and vanzacaftor/tezacaftor/deutivacaftor.</p>","Y","N","N","null","null","N","2025-12-01","N","4708"
"34580_N","null","null","null","null","null","<p align=""left"">The assessment for Juvenile Spondyloarthritis Disease Activity Index score is available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC4245319/table/T2/.</p>","Y","N","N","null","null","N","2025-12-10","N","4708"
"34683_N","null","null","null","null","null","<p align=""left"">Pharmaceutical benefits that have the form fludarabine phosphate 50 mg injection with the brand Fludarabine Juno and pharmaceutical benefits that have the form fludarabine phosphate 50 mg/2 mL injection with the brand Fludarabine Ebewe are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2025-12-01","N","4708"
"34686_N","null","null","null","null","null","<p align=""justify"">Patients receiving lenalidomide under the PBS listing must be registered in the risk management program relevant for the brand of lenalidomide being prescribed and dispensed:</p><ul><li>Revlimid - i-access program;</li><li>Lenalidomide Dr.Reddy&apos;s - Reddy-2-Assist Controlled Access Program;</li><li>Lenalide - Juno Connected<sup>TM</sup>;</li><li>Lenalidomide Sandoz - MyCheckPoint Pregnancy Prevention Program.</li></ul>","Y","N","N","null","null","N","2025-12-10","N","4708"
"34687_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form methylphenidate hydrochloride modified release tablet can be substituted for Concerta (Switzerland) or Atenza (Spain) in the case of a shortage</p>","Y","N","N","null","null","N","2025-12-10","N","4708"
"34706_N","null","null","null","null","null","<p align=""justify"">For the purpose of administering this restriction, Schizophrenia refers to schizophrenia spectrum disorders outlined in the DSM-5 criteria.</p>","Y","N","N","null","null","N","2025-12-10","N","4708"
"34750_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the brand Methylphenidate Orifarm 60 mg (Sweden) can be substituted for Attora LA, Ritalin LA or Rubifen LA in the case of a shortage.</p>","Y","N","N","null","null","N","2026-03-01","N","4708"
"34753_C","null","null","null","null","null","<p align=""left"">The bioavailability on a mg to mg basis of abiraterone combination product Yonsa MPred to ANDRIGA-10 or abiraterone single drug product is not equivalent. When changing between abiraterone products, exercise caution in explaining correct dosing directions to the patient.</p>","N","Y","N","null","null","N","2025-12-10","N","4708"
"34754_N","null","null","null","null","null","<p align=""justify"">Where the term &apos;novel hormonal drug&apos; appears in this restriction, it refers to: (i) abiraterone, (ii) abiraterone and methylprednisolone, (iii) abiraterone and prednisolone, (iv) apalutamide, (v) darolutamide, (vi) enzalutamide.</p>","Y","N","N","null","null","N","2025-12-10","N","4708"
"34755_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form aflibercept 0.09 mL injection syringe, pharmaceutical benefits that have the form aflibercept 0.165 mL injection syringe and pharmaceutical benefits that have the form aflibercept 0.1 mL injection vial are equivalent for the purposes of substitution</p>","Y","N","N","null","null","N","2026-02-01","N","4708"
"34838_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the brand Praziquantel tablets, USP 600 mg (Endo, USA) can be substituted for pharmaceutical benefits that have the brand Distocide (Korea) in the case of a shortage.</p>","Y","N","N","null","null","N","2026-03-01","N","4708"
"34855_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg can be substituted for Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg and efavirenz 600 mg in the case of a shortage.</p>","Y","N","N","null","null","N","2026-03-01","N","4708"
"34939_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the following forms are equivalent for the purposes of substitution: </p><ul><li>desmopressin acetate 10 microgram/actuation nasal spray, 50 actuations; and </li><li>desmopressin acetate 10 microgram/actuation nasal spray, 60 actuations.</li></ul>","Y","N","N","null","null","N","2026-04-01","N","4708"
"34982_N","null","null","null","null","null","<p align=""justify""><u>Treatment switching:</u></p><p align=""justify"">Switching between gMG biological agents is permitted. Treatment switching should be limited to when a patient moves between different treatment settings, i.e. moving from &apos;acute severe gMG&apos; to &apos;bridging therapy for gMG&apos; [(1) to (2)]; or moving from &apos;bridging therapy for gMG&apos; to &apos;treatment refractory gMG&apos; [(2) to (3)].</p><p align=""justify"">In the acute severe (1) or bridging therapy (2) settings a patient may switch to an alternate gMG biological agent if they are experiencing an intolerance or toxicity necessitating treatment withdrawal. Patients can switch by requalifying through the relevant restrictions. Only a balance of the time limits specified within the relevant treatment setting will be approved i.e. the remaining of the 3 months (acute severe gMG); or 6 months (bridging therapy for gMG) after accounting for the treatment of the previous gMG biologic.</p><p align=""justify"">In the treatment refractory setting (3), a patient may switch to an alternate gMG biological agent via either:</p><p align=""justify"">a) the initial restriction if they have trialled a different gMG biologic, but did not respond to treatment; or</p><p align=""justify"">b) the continuing restriction if they have trialled a different gMG biological agent and have responded to treatment.</p><p align=""justify"">Mark any remaining unused repeat prescriptions as &quot;cancelled&quot;.</p>","Y","N","N","null","null","N","2026-04-01","N","4708"
"34985_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the following forms are equivalent for the purposes of substitution: </p><ul><li>Desmopressin 120 microgram sublingual tablet; and</li><li>Desmopressin 120 microgram sublingual wafer.</li></ul>","Y","N","N","null","null","N","2026-04-01","N","4708"
"34986_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the following forms are equivalent for the purposes of substitution:</p><ul><li>Desmopressin 240 microgram sublingual tablet; and</li><li>Desmopressin 240 microgram sublingual wafer.</li></ul>","Y","N","N","null","null","N","2026-04-01","N","4708"
"35043_C","null","null","null","null","null","<p align=""justify"">Hypersensitivity reactions and cases of anaphylaxis have been reported following the administration of edaravone. Patients should be monitored carefully for hypersensitivity reactions following administration. For more information on administration schedule, refer to the approved Therapeutic Goods Administration (TGA) Product Information.</p>","N","Y","N","null","null","N","2026-04-01","N","4708"
"35060_C","null","null","null","null","null","<p align=""justify"">Thiamine levels should be assessed as per the approved Therapeutic Goods Administration (TGA) Product Information (PI) prior to receiving treatment and should be closely monitored throughout the treatment period.</p>","N","Y","N","null","null","N","2026-04-01","N","4708"
"35061_N","null","null","null","null","null","<p align=""justify"">Patients receiving pomalidomide under the PBS listing must be registered in the risk management program relevant for the brand of pomalidomide being prescribed and dispensed: Pomolide - Juno&apos;s Pregnancy Prevention Program; Pomalidomide Sandoz - Pregnancy Prevention Program.</p>","Y","N","N","null","null","N","2026-04-01","N","4708"
"35159_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the brand Salbutamol (as sulfate) (Accord, UK) may be substituted for pharmaceutical benefits that have the brand Ventolin Nebules or Salbutamol Cipla in case of shortage.</p>","Y","N","N","null","null","N","2026-05-01","N","4708"
"35167_C","null","null","null","null","null","<p align=""justify"">The anticholinergic effect of this medicine may exacerbate pre-existing medical conditions including but not limited to cardiac arrhythmias.</p>","N","Y","N","null","null","N","2026-05-01","N","4708"
"35182_N","null","null","null","null","null","<p align=""justify""><u>Definitions for the purposes of administering this restriction.</u></p><p align=""justify"">Where the term <b>&apos;gMG biological agent&apos;</b> is referenced in this restriction, it refers to ravulizumab, rozanolixizumab and zilucoplan.</p><p align=""justify"">A non-steroidal immunosuppressant (NS-IST) is one of the following:</p><p align=""justify"">(i) azathioprine,</p><p align=""justify"">(ii) ciclosporin,</p><p align=""justify"">(iii) cyclophosphamide,</p><p align=""justify"">(iv) methotrexate,</p><p align=""justify"">(v) mycophenolate</p><p align=""justify"">(vi) tacrolimus</p><p align=""justify"">The Myasthenia Gravis Foundation of America (<b>MGFA</b>) Disease Classification can be accessed at https://myasthenia.org/wp-content/uploads/Portals/0/MGFA%20Classification.pdf</p><p align=""justify"">The Myasthenia Gravis Composite (<b>MGC</b>) scoring profile can be accessed at https://www.criteria.blood.gov.au/NeurologicalScales#MGC</p><p align=""justify"">The Myasthenia Gravis-Activities of Daily Living (<b>MG-ADL</b>) scoring profile can be accessed at https://myasthenia.org/wp-content/uploads/Portals/0/Files/MG%20ADL%20Profile.pdf?ver=YQFk2umcz59cIOttpxZ-3w%3D%3D</p><p align=""justify""><u>The following are settings and time limits where a gMG biological agent are PBS subsidised</u>:</p><p align=""justify"">(1) Three months of acute treatment - &apos;acute severe gMG&apos;.</p><p align=""justify"">(2) Six months of bridging therapy - &apos;bridging therapy for gMG&apos;.</p><p align=""justify"">(3) Continuous therapy - &apos;treatment refractory gMG&apos;.</p><p align=""justify"">A patient may transition sequentially from one phase to another where all criteria are met e.g. (1) to (2) to (3) but cannot return to an earlier treatment setting.</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35222_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form adrenaline (epinephrine) 150 microgram/0.3 mL injection, 0.3 mL pen device and pharmaceutical benefits that have the form adrenaline (epinephrine) 150 microgram/0.15 mL injection, 0.15 mL pen device are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2026-06-01","N","4708"
"35223_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form adrenaline (epinephrine) 300 microgram/0.3 mL injection, 0.3 mL pen device (Adrenaline Viatris, Anapen 300 and EpiPen) and pharmaceutical benefits that have the form adrenaline (epinephrine) 300 microgram/0.3 mL injection, 0.3 mL pen device (Jext) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2026-06-01","N","4708"
"35242_N","null","null","null","null","null","<p align=""justify"">A patient may only qualify for PBS-subsidised treatment under this restriction twice in a lifetime.</p>","Y","N","N","null","null","N","2026-06-01","N","4708"
"35281_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms Selpercatinib 40 mg tablet and Selpercatinib 40 mg capsule are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35282_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms Selpercatinib 80 mg tablet and Selpercatinib 80 mg capsule are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35368_N","null","null","null","null","null","<p align=""left""><b>SEVERE CROHN DISEASE - TREATMENT PHASES AND CYCLES</b></p><p align=""left"">The following information applies to the prescribing of targeted therapies under the Pharmaceutical Benefits Scheme (PBS) for benefits with a stated indication of: &apos;Severe Crohn disease&apos;. For PBS administration, the term targeted therapy includes biological and targeted synthetic disease modifying anti-rheumatic drugs.</p><p align=""left"">A patient is eligible for PBS-subsidised treatment with only one targeted therapy at any one time.</p><p align=""left""><u>Treatment cycle:</u></p><p align=""left"">A treatment cycle begins when an authority application is approved under an Initial 1, Initial 2 patients who are accessing PBS-subsidised treatment for the first time, Initial 3 or transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient type restriction. Treatment must not continue with the same targeted therapy if it has not provided an adequate response as defined in the continuing treatment phase. A patient may trial different targeted therapies within a cycle; however, if all available targeted therapies have been trialled and have not provided an adequate response, the treatment cycle ends and a 12-month PBS exclusion period applies.</p><p align=""left"">The 12-month break is measured from the date of the last PBS approval for a targeted therapy in the most recent cycle to the date of first initial treatment application under the next treatment cycle.</p><p align=""left"">If a new targeted therapy with a different pharmacological mechanism of action becomes available on the PBS during a 12-month break, a patient may be prescribed the newly listed targeted therapy through the Initial 2 treatment phase, if they have never received that medicine previously. If the newly listed targeted therapy does not provide an adequate response, the treatment cycle ends and the 12-month break recommences. This will not be considered a new treatment cycle.</p><p align=""left"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""left""><u>Treatment phases:</u></p><p align=""left""><b>Initial 1 -</b> use when the patient has never received a targeted therapy for this indication.</p><p align=""left"">Baseline disease activity and inadequate response to conventional therapies must be demonstrated.</p><p align=""left""><b>Initial 2 -</b> use when an alternative targeted therapy is being prescribed for this indication, or when the patient has previously been treated with this targeted therapy and treatment is resuming after a break of less than 12 months.</p><p align=""left"">Baseline disease activity and inadequate response to conventional therapies do not need to be re-demonstrated; however, an assessment of response to the preceding supply must be provided if a response has been demonstrated.</p><p align=""left""><b>Initial 3 -</b> use when treatment is resuming after an absence of PBS subsidy for at least 12 months.</p><p align=""left"">Baseline disease activity must be demonstrated; however, a re-trial of conventional therapies is not required.</p><p align=""left""><b>Transitioning from non-PBS supply commenced as a paediatric patient -</b> use when the patient is receiving non-PBS-subsidised treatment with a targeted therapy for this condition and has been initiated on treatment on the same targeted therapy as a paediatric patient (prior to 18 years of age) via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program).</p><p align=""left""><b>Continuing treatment -</b> use when patient has demonstrated an adequate response to the preceding supply and/or when the dose is being increased. Continuing treatment authority scripts must not be written on the same day as Initial treatment authority applications.</p><p align=""left""><b>Balance of supply -</b> use when the full amount of the preceding supply was not provided. This phase provides the remaining quantity that could have been obtained under the preceding authority approval or where additional time is required for an adequate response to be demonstrated.</p><p align=""left""><u>Recency of assessments:</u></p><p align=""left"">Where possible, all related assessment documentation (including Crohn Disease Activity Index calculations, pathology tests and diagnostic imaging studies) should be within 4 weeks of the date of authority application but no longer than 4 weeks following cessation of the most recent treatment.</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35369_N","null","null","null","null","null","<p align=""left"">Authority applications for increased repeats may be approved by Services Australia to provide sufficient doses for the relevant treatment phase.</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35392_N","null","null","null","null","null","<p align=""left"">Pharmaceutical benefits that have the brand Phenobarbital Tablets, USP 30 mg (Rising Pharmaceuticals, USA) can be substituted for Phenobarb in the case of a shortage.</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35467_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the brand Benzylpenicillin benzathine (Brancaster Pharma, UK) or the brand Lentocilin S 1200 (Portugal) may be substituted for pharmaceutical benefits that have the brand Bicillin L-A in case of shortage.</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35513_N","null","null","null","null","null","<p align=""left"">Authority applications for increased quantities/repeats may be approved by Services Australia to provide sufficient doses for the relevant treatment phase.</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35514_N","null","null","null","null","null","<p align=""left"">Encouraging biosimilar prescribing for treatment naive patients is Government policy. A viable biosimilar market is expected to result in reduced costs for targeted therapies, allowing the Government to reinvest in new treatments. Further information can be found on the Medicines webpage (www.health.gov.au/health-topics/medicines).</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35528_N","null","null","null","null","null","<p align=""left"">Authority applications for increased quantities may be approved by Services Australia to provide sufficient doses for the relevant treatment phase.</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35531_N","null","null","null","null","null","<p align=""justify"">For copies of the ACQ and the calculation sheets please contact AstraZeneca Medical Information on 1800 805 342.</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35548_N","null","null","null","null","null","<p align=""left"">Where there is already an approved authority prescription for the IV formulation, an authority application for this subcutaneously administered form can be made under one of:</p><p align=""left"">(1) The Balance of supply listing - apply under this listing if the treatment phase is yet to be completed; the following prescription is to be under a Continuing treatment listing.</p><p align=""left"">(2) A Continuing treatment listing - apply under one of these types of listings where a patient is demonstrating a response to treatment.</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35557_C","null","null","null","null","null","<p align=""justify"">Adrenaline products have different administration techniques. These products should not be prescribed to the same patient without training in their use. Pharmacists should ensure that patients are educated regarding the product differences upon dispensing.</p>","N","Y","N","null","null","N","2026-07-01","N","4708"
"35558_N","null","null","null","null","null","<p align=""justify"">The adrenaline devices should be provided in the framework of a comprehensive anaphylaxis prevention program and an emergency action plan including training in recognition of the symptoms of anaphylaxis and the use of the device. (For further information see the Australasian Society of Clinical Immunology and Allergy website at www.allergy.org.au).</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35559_N","null","null","null","null","null","<p align=""justify""><b>TREATMENT OF ADULT AND ADOLESCENT PATIENTS WITH UNCONTROLLED SEVERE ASTHMA</b></p><p align=""justify"">The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines for uncontrolled severe asthma. Where the term biological medicine appears in the following notes and restrictions it refers to all PBS benefits with the specific PBS indication of &apos;uncontrolled severe asthma&apos;.</p><p align=""justify"">A patient is eligible for PBS-subsidised treatment with only 1 biological medicine for uncontrolled severe asthma at any one time.</p><p align=""justify"">A patient receiving PBS-subsidised treatment for uncontrolled severe asthma is able to commence a treatment cycle where they may trial a biological medicine without having to experience a disease flare when swapping to an alternate biological medicine within the same treatment cycle.</p><p align=""justify"">Under these arrangements, within a treatment cycle, a patient may receive long-term treatment with a biological medicine as long as they sustain a response to therapy.</p><p align=""justify"">A patient currently receiving PBS-subsidised treatment as of 1 April 2021 is considered to have started a cycle of treatment.</p><p align=""justify"">Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once.</p><p align=""justify"">Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment.</p><p align=""justify"">Once a patient has either failed to achieve or sustain a response to treatment with each of the biological medicines they are eligible for, they are deemed to have completed a single treatment cycle. They must have at least a 12-month break in PBS-subsidised biological medicine therapy before they are eligible to recommence another new treatment cycle [further details are under &apos;Recommencement of treatment after a treatment break in PBS-subsidised therapy&apos; below].</p><p align=""justify"">The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine is ceased until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.</p><p align=""justify"">There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.</p><p align=""justify"">How to prescribe PBS-subsidised biological medicine treatment for uncontrolled severe asthma.</p><p align=""justify"">(1) Initial treatment:</p><p align=""justify"">Applications for initial treatment should be made where:</p><p align=""justify"">(i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy (Initial 1 restriction); or</p><p align=""justify"">(ii) a patient has received prior PBS-subsidised treatment with a biological medicine and wishes to recommence a new treatment cycle with this biological medicine following a treatment break in PBS-subsidised therapy (Initial 1 restriction); or</p><p align=""justify"">(iii) a patient has received prior PBS-subsidised biological medicine therapy and wishes to trial an alternate biological medicine within the same treatment cycle (Initial 2 restriction) - [further details are under &apos;Swapping therapy&apos; below].</p><p align=""justify"">All applications for initial treatment will be limited to provide for a maximum of up to 32 weeks of therapy of a biological medicine. It is recommended that a patient be reviewed in the month prior to completing their course of initial treatment to ensure uninterrupted biological medicine supply.</p><p align=""justify"">(2) Continuing treatment:</p><p align=""justify"">Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that biological medicine providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response. It is recommended that a patient be reviewed the month prior to completing their current course of treatment to ensure uninterrupted biological medicine supply.</p><p align=""justify"">(3) Baseline measurements to determine response:</p><p align=""justify"">Baseline measurements of the Asthma Control Questionnaire (ACQ; 5 item version) or oral corticosteroid dose submitted with the Initial authority application for a biological medicine must be used to determine whether an adequate response to treatment has been achieved or sustained.</p><p align=""justify"">For patients transitioned from the paediatric to the adolescent/adult restriction, the exacerbation history may also be used to determine response.</p><p align=""justify"">However, prescribers may provide new baseline measurements when a new Initial treatment authority application is submitted and these new baseline measurements may be used to assess response.</p><p align=""justify"">(4) Swapping therapy within the same treatment cycle.</p><p align=""justify"">Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine at any time by qualifying under an Initial 2 restriction.</p><p align=""justify"">However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug within the same treatment cycle.</p><p align=""justify"">Within the same treatment cycle a patient may alternate between therapy with any biological medicine of their choice (1 at a time) providing:</p><p align=""justify"">(i) they have not received PBS-subsidised treatment with that particular biological medicine previously; or</p><p align=""justify"">(ii) they have demonstrated an adequate response to that particular biological medicine if they have previously trialled it on the PBS; and</p><p align=""justify"">(iii) they have not previously failed to respond to treatment with all eligible biological medicines in this treatment cycle.</p><p align=""justify"">(5) Re-commencement of a new treatment cycle after a treatment break in PBS-subsidised therapy:</p><p align=""justify"">A patient who wishes to trial a second or subsequent new treatment cycle, following a break in PBS-subsidised therapy of at least 12 months, must re-qualify through an Initial 1 restriction.</p><p align=""justify"">(6) Monitoring of patients:</p><p align=""justify"">Omalizumab only:</p><p align=""justify"">Anaphylaxis and anaphylactoid reactions have been reported following first or subsequent administration of omalizumab (see Product Information). Patients should be monitored post-injection, and medications for the treatment of anaphylactic reactions should be available for immediate use following administration of omalizumab. Patients should be informed that such reactions are possible and prompt medical attention should be sought if allergic reactions occur.</p>","Y","N","N","null","null","N","2026-07-01","N","4708"
"35600_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms Oxycodone hydrochloride 5 mg tablet, 20 and oxycodone hydrochloride 5 mg tablet, 10 are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2026-08-01","N","4708"
"35603_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms Oxycodone hydrochloride 5 mg capsule, 20 and oxycodone hydrochloride 5 mg capsule, 10 are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2026-08-01","N","4708"
"35703_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms clopidogrel tablet 75 mg (as besilate) and clopidogrel tablet 75 mg (as hydrogen sulfate) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2026-08-01","N","4708"
"35779_N","null","null","null","null","null","<p align=""justify"">Patients receiving clozapine under the PBS listing must be registered in the clozapine patient monitoring program relevant for the brand of clozapine being prescribed and dispensed.</p>","Y","N","N","null","null","N","2026-08-01","N","4708"
"35861_N","null","null","null","null","null","<p align=""left""><b>TREATMENT OF PAEDIATRIC PATIENTS WITH REFRACTORY CROHN DISEASE </b></p><p align=""left"">The following information applies to the prescribing of targeted therapies under the Pharmaceutical Benefits Scheme (PBS) for paediatric patients with adalimumab for &apos;severe Crohn disease&apos; and infliximab for &apos;moderate to severe Crohn disease&apos;. For PBS administration, the term targeted therapy includes biological and targeted synthetic disease modifying anti-rheumatic drugs.</p><p align=""left"">A patient is eligible for PBS-subsidised treatment with only one targeted therapy at any one time.</p><p align=""left""><u>Treatment cycle:</u></p><p align=""left"">A treatment cycle begins when an authority application is approved under an Initial 1, Initial 2 patients who are accessing PBS-subsidised treatment for the first time or Initial 3 type restriction. Treatment must not continue with the same targeted therapy if it has not provided an adequate response as defined in the continuing treatment phase. A patient may trial different targeted therapies within a cycle; however, if 3 trials of a targeted therapy do not provide an adequate response, the treatment cycle ends and a 12-month PBS exclusion period applies. A paediatric patient cannot trial and not demonstrate an adequate response, or cease to respond to, the same PBS-subsidised targeted therapy more than twice.</p><p align=""left"">The 12-month break is measured from the date of the last PBS approval for a targeted therapy in the most recent cycle to the date of first initial treatment application under the next treatment cycle.</p><p align=""left"">If a new targeted therapy with a different pharmacological mechanism of action becomes available on the PBS during a 12-month break, a patient may be prescribed the newly listed targeted therapy through the Initial 2 treatment phase, if they have never received that medicine previously. If the newly listed targeted therapy does not provide an adequate response, the treatment cycle ends and the 12-month break recommences. This will not be considered a new treatment cycle.</p><p align=""left"">There is no limit to the number of treatment cycles a patient may undertake in their lifetime.</p><p align=""left""><u>Treatment Phases:</u></p><p align=""left"">Initial treatment authorisations will be limited to provide for a maximum of 16 weeks of therapy for adalimumab and 14 weeks for infliximab.</p><p align=""left""><b>Initial 1 -</b> use when the patient has never received a PBS-subsidised targeted therapy for these indications. Inadequate response to conventional therapy must be demonstrated where required.</p><p align=""left""><b>Initial 2 -</b> use when:</p><ul><li>an alternative targeted therapy is being prescribed for these indications; or</li><li>the patient has previously been treated with this targeted therapy; or</li><li>treatment is resuming after a break of less than 12 months</li></ul><p align=""left"">Patients applying through this treatment phase do not have to requalify with respect to the indices of disease severity (i.e. Paediatric Crohn Disease Activity Index (PCDAI) Score, confirmation of Crohn disease). Inadequate response to conventional therapy does not need to be redemonstrated.</p><p align=""left""><b>Initial 3 -</b> use when treatment is resuming after a break in PBS-subsidised treatment of at least 12 months. Patients applying through this treatment phase must requalify with respect to the indices of disease severity (i.e. Paediatric Crohn Disease Activity Index (PCDAI) Score, confirmation of Crohn disease). Re-trial of conventional therapies is not required.</p><p align=""left""><b>Continuing treatment -</b> use when a patient has demonstrated an adequate response to the preceding supply. Patients are eligible for up to 24 weeks of treatment per continuing prescription. Continuing treatment authority scripts must not be written on the same day as Initial treatment authority applications.</p><p align=""left""><b>Balance of supply - </b>use when the full amount of the preceding supply was not provided. This phase provides the remaining quantity that could have been obtained under the preceding authority approval or where additional time is required for an adequate response to be determined.</p><p align=""left""><b>Baseline measurements to determine response </b><b>- </b>a response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements provided in the first authority application for a targeted therapy. However, prescribers may provide new baseline measurements any time that an initial treatment authority application is made within a treatment cycle and eligibility for continuing treatment must be assessed according to these revised baseline measurements.</p><p align=""left""><u>Recency of assessments:</u></p><p align=""left"">Where possible, all related assessment documentation (including the Paediatric Crohn Disease Activity Index calculations, pathology tests and diagnostic imaging studies) should be within 4 weeks of the date of authority application but no longer than 4 weeks following cessation of the most recent treatment.</p>","Y","N","N","null","null","N","2026-08-01","N","4708"
"35904_N","null","null","null","null","null","<p align=""left"">Consistent with clinical guidelines, therapeutic drug monitoring is recommended during drug escalation/de-escalation to target trough medication levels</p>","Y","N","N","null","null","N","2026-08-01","N","4708"
"4076_4076_R","null","RESTRICTED","4076","4076","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For a patient who is unable to take a solid dose form of atenolol.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For a patient who is unable to take a solid dose form of atenolol.</p>","N","N","N","IMMEDIATE","ALL","N","2012-12-01","N","4708"
"4084_4084_R","Management","STREAMLINED","4084","4084","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prophylaxis of renal allograft rejection</p><br/><p>Management</p><br/><p>The treatment must be under the supervision and direction of a transplant unit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Prophylaxis of renal allograft rejection</p><br/><p>Management</p><br/><p>The treatment must be under the supervision and direction of a transplant unit.</p> <p>Management includes initiation, stabilisation and review of therapy as required.</p>","N","N","N","IMMEDIATE","ALL","N","2012-12-01","N","4708"
"4095_4095_R","Management","STREAMLINED","4095","4095","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>WHO Class III, IV or V lupus nephritis</p><br/><p>Management</p><br/><p>The condition must be proven by biopsy; AND</p> <p>Must be treated by a nephrologist or in consultation with a nephrologist.</p> <p align=""justify"">The name of the consulting nephrologist must be included in the patient medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>WHO Class III, IV or V lupus nephritis</p><br/><p>Management</p><br/><p>The condition must be proven by biopsy; AND</p> <p>Must be treated by a nephrologist or in consultation with a nephrologist.</p> <p align=""justify"">The name of the consulting nephrologist must be included in the patient medical records.</p> <p>Management includes initiation, stabilisation and review of therapy as required.</p>","N","N","N","IMMEDIATE","ALL","N","2012-12-01","N","4708"
"4118_4118_R","null","RESTRICTED","4118","4118","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.</p>","N","N","N","IMMEDIATE","ALL","Y","2012-12-01","N","4708"
"4124_4124_R","null","STREAMLINED","4124","4124","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone pain</p><br/><p>The condition must be due to malignant disease; AND</p> <p>Patient must be unable to take a solid dose form of a non-steroidal anti-inflammatory agent.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone pain</p><br/><p>The condition must be due to malignant disease; AND</p> <p>Patient must be unable to take a solid dose form of a non-steroidal anti-inflammatory agent.</p>","N","N","N","IMMEDIATE","ALL","N","2012-12-01","N","4708"
"4139_4139_R","null","RESTRICTED","4139","4139","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.</p>","N","N","N","IMMEDIATE","ALL","Y","2012-12-01","N","4708"
"4159_4159_R","null","STREAMLINED","4159","4159","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies (including osteoarthritis)</p><br/><p>The condition must have an inflammatory component; AND</p> <p>Patient must be unable to take a solid dose form of a non-steroidal anti-inflammatory agent.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies (including osteoarthritis)</p><br/><p>The condition must have an inflammatory component; AND</p> <p>Patient must be unable to take a solid dose form of a non-steroidal anti-inflammatory agent.</p>","N","N","N","IMMEDIATE","ALL","N","2012-12-01","N","4708"
"4181_4181_R","null","AUTHORITY_REQUIRED","4181","4181","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bacterial keratitis</p><br/><p>Must be treated by an ophthalmologist or in consultation with an ophthalmologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bacterial keratitis</p><br/><p>Must be treated by an ophthalmologist or in consultation with an ophthalmologist.</p>","N","N","N","IMMEDIATE","ALL","N","2013-04-01","N","4708"
"4195_4195_R","null","AUTHORITY_REQUIRED","4195","4195","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bacterial keratitis</p><br/><p>Must be treated by an ophthalmologist or in consultation with an ophthalmologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bacterial keratitis</p><br/><p>Must be treated by an ophthalmologist or in consultation with an ophthalmologist.</p>","N","N","N","IMMEDIATE","ALL","N","2013-04-01","N","4708"
"4211_4211_R","null","STREAMLINED","4211","4211","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p> <p>Aprepitant is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"4215_4215_R","null","STREAMLINED","4215","4215","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND</p> <p>Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND</p> <p>Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p> <p>Aprepitant is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"4216_4216_R","null","STREAMLINED","4216","4216","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND</p> <p>Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND</p> <p>Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p> <p>Aprepitant is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"4223_4223_R","null","STREAMLINED","4223","4223","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p> <p>Aprepitant is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"4243_4243_R","null","STREAMLINED","4243","4243","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prophylaxis of urinary tract infection</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prophylaxis of urinary tract infection</p>","N","N","N","IMMEDIATE","ALL","N","2013-08-01","N","4708"
"4244_4244_R","null","AUTHORITY_REQUIRED","4244","4244","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic spasticity</p><br/><p>Patient must be under 18 years of age.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic spasticity</p><br/><p>Patient must be under 18 years of age.</p>","N","N","N","IMMEDIATE","ALL","N","2013-08-01","N","4708"
"4253_4253_R","null","RESTRICTED","4253","4253","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency.</p> <p align=""justify"">KetoCal 3:1 should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency.</p> <p align=""justify"">KetoCal 3:1 should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist.</p> <p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 48, may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2013-08-01","N","4708"
"4289_4289_R","null","RESTRICTED","4289","4289","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency.</p> <p align=""justify"">KetoCal 4:1 should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency.</p> <p align=""justify"">KetoCal 4:1 should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist.</p> <p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 48, may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2013-11-01","N","4708"
"4295_4295_R","null","RESTRICTED","4295","4295","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p>","N","N","N","IMMEDIATE","ALL","N","2013-11-01","N","4708"
"4302_4302_R","null","STREAMLINED","4302","4302","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron deficiency anaemia</p><br/><p>Patient must be undergoing chronic haemodialysis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron deficiency anaemia</p><br/><p>Patient must be undergoing chronic haemodialysis.</p>","N","N","N","IMMEDIATE","ALL","N","2013-11-01","N","4708"
"4311_4311_R","null","RESTRICTED","4311","4311","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypertension</p><br/><p>The treatment must not be for the initiation of anti-hypertensive therapy; AND</p> <p>The condition must be inadequately controlled with concomitant treatment with two of the following: an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypertension</p><br/><p>The treatment must not be for the initiation of anti-hypertensive therapy; AND</p> <p>The condition must be inadequately controlled with concomitant treatment with two of the following: an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic.</p>","N","N","N","IMMEDIATE","ALL","N","2013-12-01","N","4708"
"4313_4313_R","null","STREAMLINED","4313","4313","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human immunodeficiency virus (HIV) infection</p><br/><p>The treatment must be in addition to optimised background therapy; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>The treatment must be co-administered with 100 mg ritonavir; AND</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen; AND</p> <p>Patient must not have demonstrated darunavir resistance associated mutations detected on resistance testing.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human immunodeficiency virus (HIV) infection</p><br/><p>The treatment must be in addition to optimised background therapy; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>The treatment must be co-administered with 100 mg ritonavir; AND</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen; AND</p> <p>Patient must not have demonstrated darunavir resistance associated mutations detected on resistance testing.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p>","N","N","N","IMMEDIATE","ALL","N","2013-12-01","N","4708"
"4319_4319_R","null","STREAMLINED","4319","4319","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Onchocerciasis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Onchocerciasis</p>","N","N","N","IMMEDIATE","ALL","N","2013-12-01","N","4708"
"4328_4328_R","null","STREAMLINED","4328","4328","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Strongyloidiasis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Strongyloidiasis</p>","N","N","N","IMMEDIATE","ALL","N","2013-12-01","N","4708"
"4343_4343_R","null","RESTRICTED","4343","4343","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Elevated intra-ocular pressure</p><br/><p>The condition must have been inadequately controlled with monotherapy; AND</p> <p>Patient must have open-angle glaucoma; or</p> <p>Patient must have ocular hypertension.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Elevated intra-ocular pressure</p><br/><p>The condition must have been inadequately controlled with monotherapy; AND</p> <p>Patient must have open-angle glaucoma; or</p> <p>Patient must have ocular hypertension.</p>","N","N","N","IMMEDIATE","ALL","N","2013-12-01","N","4708"
"4414_4414_R","Continuing treatment","AUTHORITY_REQUIRED","4414","4414","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must have responded to an initial course of PBS-subsidised treatment; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align=""justify"">Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must have responded to an initial course of PBS-subsidised treatment; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align=""justify"">Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.</p><p/> <p/><p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 52, may be authorised.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2014-01-01","N","4708"
"4415_4415_R","null","AUTHORITY_REQUIRED","4415","4415","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe intestinal malabsorption including short bowel syndrome</p><br/><p>Patient must have failed to respond to protein hydrolysate formulae; or</p> <p>Patient must have been receiving parenteral nutrition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe intestinal malabsorption including short bowel syndrome</p><br/><p>Patient must have failed to respond to protein hydrolysate formulae; or</p> <p>Patient must have been receiving parenteral nutrition.</p> <p/><p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2014-01-01","N","4708"
"4433_4433_R","null","STREAMLINED","4433","4433","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia of malignancy</p><br/><p>Patient must have a malignancy refractory to anti-neoplastic therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia of malignancy</p><br/><p>Patient must have a malignancy refractory to anti-neoplastic therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2014-02-01","N","4708"
"4438_4438_R","null","RESTRICTED","4438","4438","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven inborn errors of protein metabolism</p><br/><p>Patient must be unable to meet their energy requirements with permitted food and formulae.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven inborn errors of protein metabolism</p><br/><p>Patient must be unable to meet their energy requirements with permitted food and formulae.</p>","N","N","N","IMMEDIATE","ALL","N","2014-03-01","N","4708"
"4454_4454_R","Continuing","STREAMLINED","4454","4454","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>","N","N","N","IMMEDIATE","ALL","N","2014-04-01","N","4708"
"4470_4470_R","Continuing","STREAMLINED","4470","4470","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection.</p>","N","N","N","IMMEDIATE","ALL","N","2014-04-01","N","4708"
"4475_4475_R","null","RESTRICTED","4475","4475","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic bronchitis</p><br/><p>Patient must be aged 8 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic bronchitis</p><br/><p>Patient must be aged 8 years or older.</p> <p align=""justify"">Pharmaceutical benefits that have the forms doxycycline tablet 50 mg (as hyclate (hydrochloride)), doxycycline tablet 50 mg (as monohydrate) and doxycycline modified release capsule 50 mg (as hyclate (hydrochloride)) are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2014-04-01","N","4708"
"4485_4485_R","null","RESTRICTED","4485","4485","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urethritis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urethritis</p> <p align=""justify"">Pharmaceutical benefits that have the forms doxycycline tablet 100 mg (as hyclate (hydrochloride)), doxycycline tablet 100 mg (as monohydrate) and doxycycline modified release capsule 100 mg (as hyclate (hydrochloride)) are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2014-04-01","N","4708"
"4512_4512_R","Initial","STREAMLINED","4512","4512","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>","N","N","N","IMMEDIATE","ALL","N","2014-04-01","N","4708"
"4514_4514_R","null","RESTRICTED","4514","4514","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pelvic inflammatory disease</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pelvic inflammatory disease</p> <p align=""justify"">Pharmaceutical benefits that have the forms doxycycline tablet 100 mg (as hyclate (hydrochloride)), doxycycline tablet 100 mg (as monohydrate) and doxycycline modified release capsule 100 mg (as hyclate (hydrochloride)) are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2014-04-01","N","4708"
"4522_4522_R","Initial","STREAMLINED","4522","4522","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial</p><br/><p>Patient must be antiretroviral treatment naive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial</p><br/><p>Patient must be antiretroviral treatment naive.</p>","N","N","N","IMMEDIATE","ALL","N","2014-04-01","N","4708"
"4524_4524_R","null","STREAMLINED","4524","4524","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute severe ulcerative colitis</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology]; AND</p> <p>Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND</p> <p>Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; or</p> <p>Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND</p> <p>Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital; AND</p> <p>Patient must be 6 years of age or older.</p> <p/><p align=""justify"">For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where:</p><p/><p align=""justify"">(i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L</p><p/><p align=""justify"">(ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood.</p><p/><p align=""justify"">For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours.</p><p/> <p/><p align=""justify"">At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.</p><p/><p align=""justify"">Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient&apos;s medical records.</p><p/> <p/><p align=""justify"">Evidence that the patient meets the PBS restriction criteria must be recorded in the patient&apos;s medical records.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute severe ulcerative colitis</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology]; AND</p> <p>Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND</p> <p>Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; or</p> <p>Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND</p> <p>Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital; AND</p> <p>Patient must be 6 years of age or older.</p> <p/><p align=""justify"">For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where:</p><p/><p align=""justify"">(i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L</p><p/><p align=""justify"">(ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood.</p><p/><p align=""justify"">For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours.</p><p/> <p/><p align=""justify"">At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.</p><p/><p align=""justify"">Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient&apos;s medical records.</p><p/> <p/><p align=""justify"">Evidence that the patient meets the PBS restriction criteria must be recorded in the patient&apos;s medical records.</p><p/> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2014-04-01","N","4708"
"4527_4527_R","Initial","STREAMLINED","4527","4527","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>Patient must be aged 12 years or older; AND</p> <p>Patient must weigh 40 kg or more.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>Patient must be aged 12 years or older; AND</p> <p>Patient must weigh 40 kg or more.</p>","N","N","N","IMMEDIATE","ALL","N","2014-04-01","N","4708"
"4528_4528_R","Continuing","STREAMLINED","4528","4528","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>Patient must be aged 12 years or older; AND</p> <p>Patient must weigh 40 kg or more.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>Patient must be aged 12 years or older; AND</p> <p>Patient must weigh 40 kg or more.</p>","N","N","N","IMMEDIATE","ALL","N","2014-04-01","N","4708"
"4529_4529_R","null","RESTRICTED","4529","4529","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p> <p align=""justify"">Pharmaceutical benefits that have the forms doxycycline tablet 50 mg (as hyclate (hydrochloride)), doxycycline tablet 50 mg (as monohydrate) and doxycycline modified release capsule 50 mg (as hyclate (hydrochloride)) are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2014-04-01","N","4708"
"4539_4539_R","null","RESTRICTED","4539","4539","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchiectasis</p><br/><p>Patient must be aged 8 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchiectasis</p><br/><p>Patient must be aged 8 years or older.</p> <p align=""justify"">Pharmaceutical benefits that have the forms doxycycline tablet 50 mg (as hyclate (hydrochloride)), doxycycline tablet 50 mg (as monohydrate) and doxycycline modified release capsule 50 mg (as hyclate (hydrochloride)) are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2014-04-01","N","4708"
"4549_4549_R","null","STREAMLINED","4549","4549","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mobilisation of haematopoietic stem cells</p><br/><p>The treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); AND</p> <p>Patient must have lymphoma; or</p> <p>Patient must have multiple myeloma; AND</p> <p>Patient must require autologous stem cell transplantation; AND</p> <p>Patient must have failed previous stem cell collection; or</p> <p>Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; or</p> <p>Patient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.</p> <p/><p align=""justify"">Evidence that the patient meets the PBS restriction criteria must be recorded in the patient&apos;s medical records.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mobilisation of haematopoietic stem cells</p><br/><p>The treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); AND</p> <p>Patient must have lymphoma; or</p> <p>Patient must have multiple myeloma; AND</p> <p>Patient must require autologous stem cell transplantation; AND</p> <p>Patient must have failed previous stem cell collection; or</p> <p>Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; or</p> <p>Patient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.</p> <p/><p align=""justify"">Evidence that the patient meets the PBS restriction criteria must be recorded in the patient&apos;s medical records.</p><p/> <p align=""justify"">Applications for increased maximum quantities will only be authorised for patients with body weight greater than 100 kg. </p>","N","N","N","IMMEDIATE","ALL","N","2014-05-01","N","4708"
"4554_4554_R","null","AUTHORITY_REQUIRED","4554","4554","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solar keratosis</p><br/><p>Patient must require topical drug therapy on the face and scalp as field treatment for clinically visible and subclinical lesions where other standard treatments are inappropriate.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solar keratosis</p><br/><p>Patient must require topical drug therapy on the face and scalp as field treatment for clinically visible and subclinical lesions where other standard treatments are inappropriate.</p> <p align=""justify"">Pharmaceutical benefits that have the form imiquimod single use sachets and pharmaceutical benefits that have the form imiquimod multi-use pump are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2014-06-01","N","4708"
"4555_4555_R","null","RESTRICTED","4555","4555","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p> <p>Arginine with carbohydrate is not indicated for the treatment of arginase deficiency and other inborn errors of protein metabolism. </p>","N","N","N","IMMEDIATE","ALL","N","2014-06-01","N","4708"
"4565_4565_R","null","STREAMLINED","4565","4565","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Crusted (Norwegian) scabies</p><br/><p>The condition must be established by clinical and/or parasitological examination; AND</p> <p>Patient must be undergoing topical therapy for this condition; or</p> <p>Patient must have a contraindication to topical treatment; AND</p> <p>Patient must weigh 15 kg or over; AND</p> <p>Patient must be 5 years of age or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Crusted (Norwegian) scabies</p><br/><p>The condition must be established by clinical and/or parasitological examination; AND</p> <p>Patient must be undergoing topical therapy for this condition; or</p> <p>Patient must have a contraindication to topical treatment; AND</p> <p>Patient must weigh 15 kg or over; AND</p> <p>Patient must be 5 years of age or older.</p>","N","N","N","IMMEDIATE","ALL","N","2014-07-01","N","4708"
"4566_4566_R","null","STREAMLINED","4566","4566","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human sarcoptic scabies</p><br/><p>The condition must be established by clinical and/or parasitological examination; AND</p> <p>Patient must have completed and failed sequential treatment with topical permethrin and benzyl benzoate and finished the most recent course of topical therapy at least 4 weeks prior to initiating oral therapy; or</p> <p>Patient must have a contraindication to topical treatment; AND</p> <p>Patient must weigh 15 kg or over; AND</p> <p>Patient must be 5 years of age or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human sarcoptic scabies</p><br/><p>The condition must be established by clinical and/or parasitological examination; AND</p> <p>Patient must have completed and failed sequential treatment with topical permethrin and benzyl benzoate and finished the most recent course of topical therapy at least 4 weeks prior to initiating oral therapy; or</p> <p>Patient must have a contraindication to topical treatment; AND</p> <p>Patient must weigh 15 kg or over; AND</p> <p>Patient must be 5 years of age or older.</p> <p align=""justify"">This drug is not PBS-subsidised for first line treatment of typical scabies.</p>","N","N","N","IMMEDIATE","ALL","N","2014-07-01","N","4708"
"4575_4575_R","null","STREAMLINED","4575","4575","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months'' therapy at a dose of 120 mg every 28 days.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months'' therapy at a dose of 120 mg every 28 days.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2014-07-01","N","4708"
"4586_4586_R","null","STREAMLINED","4586","4586","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>The condition must be associated with chronic renal failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>The condition must be associated with chronic renal failure.</p>","N","N","N","IMMEDIATE","ALL","N","2014-08-01","N","4708"
"4600_4600_R","Continuing treatment","STREAMLINED","4600","4600","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug prior to 1 August 2014; AND</p> <p>Patient must not have progressive disease; AND</p> <p>Patient must have a wild type epidermal growth factor receptor (EGFR) gene; or</p> <p>Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously been issued with an authority prescription for this drug prior to 1 August 2014; AND</p> <p>Patient must not have progressive disease; AND</p> <p>Patient must have a wild type epidermal growth factor receptor (EGFR) gene; or</p> <p>Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type.</p>","N","N","N","IMMEDIATE","ALL","N","2014-08-01","N","4708"
"4651_4651_R","null","RESTRICTED","4651","4651","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperlipoproteinaemia type 1</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperlipoproteinaemia type 1</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p align=""justify"">Not indicated for the treatment of intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect requiring a ketogenic diet. </p>","N","N","N","IMMEDIATE","ALL","N","2014-11-01","N","4708"
"4652_4652_R","null","RESTRICTED","4652","4652","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylous ascites</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylous ascites</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p align=""justify"">Not indicated for the treatment of intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect requiring a ketogenic diet. </p>","N","N","N","IMMEDIATE","ALL","N","2014-11-01","N","4708"
"4653_4653_R","null","RESTRICTED","4653","4653","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylothorax</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylothorax</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p align=""justify"">Not indicated for the treatment of intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect requiring a ketogenic diet. </p>","N","N","N","IMMEDIATE","ALL","N","2014-11-01","N","4708"
"4657_4657_R","null","STREAMLINED","4657","4657","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) adenocarcinoma of the pancreas</p><br/><p>The treatment must be in combination with gemcitabine; AND</p> <p>The condition must not have been treated previously with PBS-subsidised therapy; AND</p> <p>Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) adenocarcinoma of the pancreas</p><br/><p>The treatment must be in combination with gemcitabine; AND</p> <p>The condition must not have been treated previously with PBS-subsidised therapy; AND</p> <p>Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">Not for use as neoadjuvant or adjuvant therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2014-11-01","N","4708"
"4659_4659_R","null","RESTRICTED","4659","4659","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Long chain fatty acid oxidation disorders</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Long chain fatty acid oxidation disorders</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p align=""justify"">Not indicated for the treatment of intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect requiring a ketogenic diet. </p>","N","N","N","IMMEDIATE","ALL","N","2014-11-01","N","4708"
"4660_4660_R","null","RESTRICTED","4660","4660","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a source of medium chain triglycerides</p><br/><p>Patient must have fat malabsorption due to liver disease; or</p> <p>Patient must have fat malabsorption due to short gut syndrome; or</p> <p>Patient must have fat malabsorption due to cystic fibrosis; or</p> <p>Patient must have fat malabsorption due to gastrointestinal disorders.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a source of medium chain triglycerides</p><br/><p>Patient must have fat malabsorption due to liver disease; or</p> <p>Patient must have fat malabsorption due to short gut syndrome; or</p> <p>Patient must have fat malabsorption due to cystic fibrosis; or</p> <p>Patient must have fat malabsorption due to gastrointestinal disorders.</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p align=""justify"">Not indicated for the treatment of intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect requiring a ketogenic diet. </p>","N","N","N","IMMEDIATE","ALL","N","2014-11-01","N","4708"
"4680_4680_R","null","RESTRICTED","4680","4680","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depressive disorders</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depressive disorders</p>","N","N","N","IMMEDIATE","ALL","N","2014-12-01","N","4708"
"4681_4681_R","null","RESTRICTED","4681","4681","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","N","N","N","IMMEDIATE","ALL","N","2014-12-01","N","4708"
"4690_4690_R","null","RESTRICTED","4690","4690","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","N","N","N","IMMEDIATE","ALL","N","2014-12-01","N","4708"
"4703_4703_R","null","RESTRICTED","4703","4703","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","N","N","N","IMMEDIATE","ALL","N","2014-12-01","N","4708"
"4704_4704_R","null","RESTRICTED","4704","4704","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Isovaleric acidaemia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Isovaleric acidaemia</p>","N","N","N","IMMEDIATE","ALL","N","2014-12-01","N","4708"
"4707_4707_R","null","RESTRICTED","4707","4707","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","N","N","N","IMMEDIATE","ALL","N","2014-12-01","N","4708"
"4709_4709_R","null","RESTRICTED","4709","4709","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency.</p> <p align=""justify"">KetoCal 4:1 should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency.</p> <p align=""justify"">KetoCal 4:1 should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist.</p> <p/><p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 11, may be authorised.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2014-12-01","N","4708"
"4721_4721_R","null","RESTRICTED","4721","4721","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","N","N","N","IMMEDIATE","ALL","N","2014-12-01","N","4708"
"4747_4747_R","null","RESTRICTED","4747","4747","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","N","N","N","IMMEDIATE","ALL","N","2014-12-01","N","4708"
"4755_4755_R","null","RESTRICTED","4755","4755","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depressive disorders</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Major depressive disorders</p>","N","N","N","IMMEDIATE","ALL","N","2014-12-01","N","4708"
"4756_4756_R","null","RESTRICTED","4756","4756","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe generalised anxiety disorder (GAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must have been assessed by a psychiatrist.</p>","N","N","N","IMMEDIATE","ALL","N","2014-12-01","N","4708"
"4757_4757_R","null","RESTRICTED","4757","4757","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe social anxiety disorder (social phobia, SAD)</p><br/><p>The condition must be defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria; AND</p> <p>Patient must not have responded to non-pharmacological therapy; AND</p> <p>Patient must be one for whom a GP Mental Health Care Plan, as described under items 2715 or 2717 of the Medicare Benefits Schedule, has been prepared.</p>","N","N","N","IMMEDIATE","ALL","N","2014-12-01","N","4708"
"4785_4785_R","Initial treatment","STREAMLINED","4785","4785","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx</p><br/><p>Initial treatment</p><br/><p>The treatment must be in combination with radiotherapy; AND</p> <p>Patient must be unable to tolerate cisplatin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx</p><br/><p>Initial treatment</p><br/><p>The treatment must be in combination with radiotherapy; AND</p> <p>Patient must be unable to tolerate cisplatin.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2015-02-01","N","4708"
"4788_4788_R","Continuing treatment","STREAMLINED","4788","4788","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx</p><br/><p>Continuing treatment</p><br/><p>The treatment must be in combination with radiotherapy; AND</p> <p>Patient must be unable to tolerate cisplatin; or</p> <p>Patient must have a contraindication to cisplatin according to the TGA-approved Product Information.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx</p><br/><p>Continuing treatment</p><br/><p>The treatment must be in combination with radiotherapy; AND</p> <p>Patient must be unable to tolerate cisplatin; or</p> <p>Patient must have a contraindication to cisplatin according to the TGA-approved Product Information.</p> <p/><p align=""justify"">A maximum lifetime supply for this indication is limited to a maximum of 8 treatments per site and to 10 treatments per site for patients in whom radiotherapy is interrupted.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2015-02-01","N","4708"
"4793_4793_R","Induction and consolidation treatment","STREAMLINED","4793","4793","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute promyelocytic leukaemia</p><br/><p>Induction and consolidation treatment</p><br/><p>The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript; AND</p> <p>The condition must be relapsed; AND</p> <p>Patient must be arsenic naive at induction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute promyelocytic leukaemia</p><br/><p>Induction and consolidation treatment</p><br/><p>The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript; AND</p> <p>The condition must be relapsed; AND</p> <p>Patient must be arsenic naive at induction.</p>","N","N","N","IMMEDIATE","ALL","N","2015-02-01","N","4708"
"4794_4794_R","Initial treatment","STREAMLINED","4794","4794","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx</p><br/><p>Initial treatment</p><br/><p>The treatment must be for the week prior to radiotherapy; AND</p> <p>Patient must have a contraindication to cisplatin according to the TGA-approved Product Information.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx</p><br/><p>Initial treatment</p><br/><p>The treatment must be for the week prior to radiotherapy; AND</p> <p>Patient must have a contraindication to cisplatin according to the TGA-approved Product Information.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2015-02-01","N","4708"
"4899_4899_R","null","RESTRICTED","4899","4899","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4907_4907_R","null","RESTRICTED","4907","4907","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Rheumatoid arthritis</p><br/><p>The treatment must be for symptomatic treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Rheumatoid arthritis</p><br/><p>The treatment must be for symptomatic treatment.</p> <p align=""justify"">The use of this drug for the treatment of the following conditions is not subsidised through the PBS:</p><p align=""justify"">(a) acute pain;</p><p align=""justify"">(b) soft tissue injury;</p><p align=""justify"">(c) arthrosis without an inflammatory component.</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4908_4908_R","Initial treatment","STREAMLINED","4908","4908","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have RAS wild-type metastatic colorectal cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must be previously untreated; AND</p> <p>The treatment must be in combination with first-line chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have RAS wild-type metastatic colorectal cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must be previously untreated; AND</p> <p>The treatment must be in combination with first-line chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p align=""justify"">Special Pricing Arrangements apply.</p> <p align=""justify"">This drug is not PBS-subsidised for use in combination with another anti-EGFR antibody or in combination with an anti-VEGF antibody.</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4910_4910_R","null","RESTRICTED","4910","4910","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Haemodialysis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Haemodialysis</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4912_4912_R","Continuing treatment","STREAMLINED","4912","4912","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received an initial authority prescription for this drug for first-line treatment of RAS wild-type metastatic colorectal cancer; AND</p> <p>Patient must not have progressive disease; AND</p> <p>The treatment must be in combination with first-line chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received an initial authority prescription for this drug for first-line treatment of RAS wild-type metastatic colorectal cancer; AND</p> <p>Patient must not have progressive disease; AND</p> <p>The treatment must be in combination with first-line chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p align=""justify"">Special Pricing Arrangements apply.</p> <p align=""justify"">This drug is not PBS-subsidised for use in combination with another anti-EGFR antibody or in combination with an anti-VEGF antibody.</p> <p align=""justify"">This drug is not PBS-subsidised when chemotherapy partners are switched whilst maintaining an anti-EGFR antibody backbone in the face of progressive disease.</p> <p align=""justify"">The treatment must not exceed a single course of therapy with this drug for metastatic colorectal cancer in a patient&apos;s lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4919_4919_R","null","STREAMLINED","4919","4919","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Coronary artery disease</p><br/><p>Patient must be undergoing percutaneous coronary intervention.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Coronary artery disease</p><br/><p>Patient must be undergoing percutaneous coronary intervention.</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4923_4923_R","null","RESTRICTED","4923","4923","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tyrosinaemia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tyrosinaemia</p> <p align=""justify"">Changes in vitamin D levels and amino acid composition have occurred with a recent formulation change.</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4924_4924_R","null","RESTRICTED","4924","4924","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4925_4925_R","null","RESTRICTED","4925","4925","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gyrate atrophy of the choroid and retina</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gyrate atrophy of the choroid and retina</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4934_4934_R","null","RESTRICTED","4934","4934","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4944_4944_R","null","RESTRICTED","4944","4944","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypertension</p><br/><p>Patient must be receiving concurrent antihypertensive therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypertension</p><br/><p>Patient must be receiving concurrent antihypertensive therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4954_4954_R","null","RESTRICTED","4954","4954","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Maple syrup urine disease</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Maple syrup urine disease</p> <p align=""justify"">Changes in vitamin D levels and amino acid composition have occurred with a recent formulation change.</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4958_4958_R","null","RESTRICTED","4958","4958","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4961_4961_R","Acute treatment","RESTRICTED","4961","4961","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne vulgaris</p><br/><p>Acute treatment</p><br/><p>The treatment must in combination with an oral antibiotic.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne vulgaris</p><br/><p>Acute treatment</p><br/><p>The treatment must in combination with an oral antibiotic.</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4962_4962_R","null","RESTRICTED","4962","4962","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoarthritis</p><br/><p>The treatment must be for symptomatic treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoarthritis</p><br/><p>The treatment must be for symptomatic treatment.</p> <p align=""justify"">The use of this drug for the treatment of the following conditions is not subsidised through the PBS:</p><p align=""justify"">(a) acute pain;</p><p align=""justify"">(b) soft tissue injury;</p><p align=""justify"">(c) arthrosis without an inflammatory component.</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4963_4963_R","null","RESTRICTED","4963","4963","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious staphylococcal infections</p><br/><p>The treatment must be used in combination with another antibiotic; AND</p> <p>The condition must be proven to be due to a staphylococcus.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious staphylococcal infections</p><br/><p>The treatment must be used in combination with another antibiotic; AND</p> <p>The condition must be proven to be due to a staphylococcus.</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4964_4964_R","null","RESTRICTED","4964","4964","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p> <p align=""justify"">Changes in vitamin D levels and amino acid composition have occurred with a recent formulation change.</p>","N","N","N","IMMEDIATE","ALL","N","2015-06-01","N","4708"
"4980_4980_R","null","STREAMLINED","4980","4980","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus retinitis</p><br/><p>Patient must have HIV infection.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus retinitis</p><br/><p>Patient must have HIV infection.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"4993_4993_R","null","STREAMLINED","4993","4993","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must not have cirrhosis; AND</p> <p>Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; or</p> <p>Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND</p> <p>Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must not have cirrhosis; AND</p> <p>Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; or</p> <p>Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND</p> <p>Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"4996_4996_R","null","RESTRICTED","4996","4996","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients unable to take a solid dose form of an ACE inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Use of ACE inhibitors during pregnancy is contraindicated since these drugs have been associated with foetal death in utero.</p> <p>Patients unable to take a solid dose form of an ACE inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"4997_4997_R","null","STREAMLINED","4997","4997","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>The treatment must be for luteal phase support as part of an assisted reproductive technology (ART) treatment cycle for infertile women; AND</p> <p>Patient must be receiving medical services as described in items 13200 or 13201 of the Medicare Benefits Schedule.</p> <p align=""justify"">The luteal phase is defined as the time span from embryo transfer until implantation confirmed by positive B-hCG measurement.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>The treatment must be for luteal phase support as part of an assisted reproductive technology (ART) treatment cycle for infertile women; AND</p> <p>Patient must be receiving medical services as described in items 13200 or 13201 of the Medicare Benefits Schedule.</p> <p align=""justify"">The luteal phase is defined as the time span from embryo transfer until implantation confirmed by positive B-hCG measurement.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"5000_5000_R","null","STREAMLINED","5000","5000","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus retinitis</p><br/><p>Patient must be severely immunocompromised, including due to HIV infection.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus retinitis</p><br/><p>Patient must be severely immunocompromised, including due to HIV infection.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"5008_5008_R","null","STREAMLINED","5008","5008","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Patient must be infected with CCR5-tropic HIV-1; AND</p> <p>The treatment must be in addition to optimised background therapy; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p> <p>A tropism assay to determine CCR5 only strain status must be performed prior to initiation. Individuals with CXCR4 tropism demonstrated at any time point are not eligible.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Patient must be infected with CCR5-tropic HIV-1; AND</p> <p>The treatment must be in addition to optimised background therapy; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p> <p>A tropism assay to determine CCR5 only strain status must be performed prior to initiation. Individuals with CXCR4 tropism demonstrated at any time point are not eligible.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"5009_5009_R","null","STREAMLINED","5009","5009","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>The treatment must be for controlled ovarian stimulation; AND</p> <p>Patient must have an antral follicle count of 20 or less; AND</p> <p>Patient must be receiving medical services as described in items 13200, 13201, or 13202 of the Medicare Benefits Schedule; AND</p> <p>Patient must be undergoing a gonadotrophin releasing antagonist cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>The treatment must be for controlled ovarian stimulation; AND</p> <p>Patient must have an antral follicle count of 20 or less; AND</p> <p>Patient must be receiving medical services as described in items 13200, 13201, or 13202 of the Medicare Benefits Schedule; AND</p> <p>Patient must be undergoing a gonadotrophin releasing antagonist cycle.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"5012_5012_R","null","RESTRICTED","5012","5012","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p> <p>This product contains higher vitamin A levels than other PBS-listed glycomacropeptide products.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"5014_5014_R","null","STREAMLINED","5014","5014","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>The treatment must be in addition to optimised background therapy; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>Patient must be antiretroviral experienced; AND</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>The treatment must be in addition to optimised background therapy; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>Patient must be antiretroviral experienced; AND</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"5027_5027_R","null","STREAMLINED","5027","5027","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"5036_5036_R","null","STREAMLINED","5036","5036","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must have cirrhosis; AND</p> <p>Patient must have detectable HBV DNA.</p> <p align=""justify"">Patients with Child&apos;s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must have cirrhosis; AND</p> <p>Patient must have detectable HBV DNA.</p> <p align=""justify"">Patients with Child&apos;s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"5037_5037_R","null","STREAMLINED","5037","5037","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must have cirrhosis; AND</p> <p>Patient must have failed lamivudine; AND</p> <p>Patient must have detectable HBV DNA.</p> <p align=""justify"">Patients with Child&apos;s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must have cirrhosis; AND</p> <p>Patient must have failed lamivudine; AND</p> <p>Patient must have detectable HBV DNA.</p> <p align=""justify"">Patients with Child&apos;s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.</p> <p align=""justify"">PBS-subsidised entecavir monohydrate must be used as monotherapy.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"5038_5038_R","null","RESTRICTED","5038","5038","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Elevated intra-ocular pressure</p><br/><p>The condition must have been inadequately controlled with monotherapy; AND</p> <p>Patient must have open-angle glaucoma; or</p> <p>Patient must have ocular hypertension.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Elevated intra-ocular pressure</p><br/><p>The condition must have been inadequately controlled with monotherapy; AND</p> <p>Patient must have open-angle glaucoma; or</p> <p>Patient must have ocular hypertension.</p> <p/><p align=""justify""> For prescribing in accordance with Optometry Board of Australia guidelines.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"5044_5044_R","null","STREAMLINED","5044","5044","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must not have cirrhosis; AND</p> <p>Patient must have failed lamivudine; AND</p> <p>Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; or</p> <p>Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must not have cirrhosis; AND</p> <p>Patient must have failed lamivudine; AND</p> <p>Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; or</p> <p>Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance.</p> <p align=""justify"">PBS-subsidised entecavir monohydrate must be used as monotherapy.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"5045_5045_R","null","STREAMLINED","5045","5045","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>The treatment must be for luteal phase support as part of an assisted reproductive technology (ART) treatment cycle for infertile women; AND</p> <p>Patient must be receiving medical services as described in items 13200 or 13201 of the Medicare Benefits Schedule.</p> <p align=""justify"">The luteal phase is defined as the time span from embryo transfer until implantation confirmed by positive B-hCG measurement.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>The treatment must be for luteal phase support as part of an assisted reproductive technology (ART) treatment cycle for infertile women; AND</p> <p>Patient must be receiving medical services as described in items 13200 or 13201 of the Medicare Benefits Schedule.</p> <p align=""justify"">The luteal phase is defined as the time span from embryo transfer until implantation confirmed by positive B-hCG measurement.</p> <p align=""justify"">Special Pricing Arrangements apply.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"5046_5046_R","null","STREAMLINED","5046","5046","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>The treatment must be for prevention of premature luteinisation and ovulation; AND</p> <p>Patient must be undergoing controlled ovarian stimulation; AND</p> <p>Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>The treatment must be for prevention of premature luteinisation and ovulation; AND</p> <p>Patient must be undergoing controlled ovarian stimulation; AND</p> <p>Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule.</p>","N","N","N","IMMEDIATE","ALL","N","2015-07-01","N","4708"
"5087_5087_R","Initial PBS-subsidised treatment","AUTHORITY_REQUIRED","5087","5087","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe facial lipoatrophy</p><br/><p>Initial PBS-subsidised treatment</p><br/><p>The treatment must be for facial administration only; AND</p> <p>The condition must be caused by therapy for HIV infection.</p> <p align=""justify"">Accreditation following completion of injection administration training with Galderma is required to prescribe poly-l-lactic acid under the PBS. Patients must be referred from the HIV physician to the accredited injector.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe facial lipoatrophy</p><br/><p>Initial PBS-subsidised treatment</p><br/><p>The treatment must be for facial administration only; AND</p> <p>The condition must be caused by therapy for HIV infection.</p> <p align=""justify"">Accreditation following completion of injection administration training with Galderma is required to prescribe poly-l-lactic acid under the PBS. Patients must be referred from the HIV physician to the accredited injector.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p>Authority applications may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2015-08-01","N","4708"
"5089_5089_R","null","STREAMLINED","5089","5089","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypophosphataemic rickets</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypophosphataemic rickets</p>","N","N","N","IMMEDIATE","ALL","N","2015-08-01","N","4708"
"5094_5094_R","null","STREAMLINED","5094","5094","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human immunodeficiency virus (HIV) infection</p><br/><p>The treatment must be in addition to optimised background therapy; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>The treatment must be co-administered with 100 mg ritonavir twice daily; AND</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human immunodeficiency virus (HIV) infection</p><br/><p>The treatment must be in addition to optimised background therapy; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>The treatment must be co-administered with 100 mg ritonavir twice daily; AND</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p>","N","N","N","IMMEDIATE","ALL","N","2015-08-01","N","4708"
"5095_5095_R","null","STREAMLINED","5095","5095","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial hypophosphataemia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Familial hypophosphataemia</p>","N","N","N","IMMEDIATE","ALL","N","2015-08-01","N","4708"
"5106_5106_R","Prophylaxis or reduction of toxicity","RESTRICTED","5106","5106","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urothelial toxicity</p><br/><p>Prophylaxis or reduction of toxicity</p><br/><p>The treatment must be adjunctive therapy to ifosfamide or high dose cyclophosphamide.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urothelial toxicity</p><br/><p>Prophylaxis or reduction of toxicity</p><br/><p>The treatment must be adjunctive therapy to ifosfamide or high dose cyclophosphamide.</p>","N","N","N","IMMEDIATE","ALL","N","2015-08-01","N","4708"
"5114_5114_R","null","STREAMLINED","5114","5114","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vitamin D-resistant rickets</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vitamin D-resistant rickets</p>","N","N","N","IMMEDIATE","ALL","N","2015-08-01","N","4708"
"5122_5122_R","Maintenance PBS-subsidised treatment","AUTHORITY_REQUIRED","5122","5122","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe facial lipoatrophy</p><br/><p>Maintenance PBS-subsidised treatment</p><br/><p>The treatment must be for facial administration only; AND</p> <p>The condition must be caused by therapy for HIV infection.</p> <p align=""justify"">Accreditation following completion of injection administration training with Galderma is required to prescribe poly-l-lactic acid under the PBS. Patients must be referred from the HIV physician to the accredited injector.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe facial lipoatrophy</p><br/><p>Maintenance PBS-subsidised treatment</p><br/><p>The treatment must be for facial administration only; AND</p> <p>The condition must be caused by therapy for HIV infection.</p> <p align=""justify"">Accreditation following completion of injection administration training with Galderma is required to prescribe poly-l-lactic acid under the PBS. Patients must be referred from the HIV physician to the accredited injector.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p>Maintenance treatment is limited to one re-treatment (maximum 2 vials) every 2 years.</p> <p>Authority applications may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2015-08-01","N","4708"
"5123_5123_R","null","STREAMLINED","5123","5123","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia</p>","N","N","N","IMMEDIATE","ALL","N","2015-08-01","N","4708"
"5130_5130_R","Prophylaxis or reduction of toxicity","RESTRICTED","5130","5130","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urothelial toxicity</p><br/><p>Prophylaxis or reduction of toxicity</p><br/><p>The treatment must be adjunctive therapy to ifosfamide or high dose cyclophosphamide.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urothelial toxicity</p><br/><p>Prophylaxis or reduction of toxicity</p><br/><p>The treatment must be adjunctive therapy to ifosfamide or high dose cyclophosphamide.</p>","N","N","N","IMMEDIATE","ALL","N","2015-08-01","N","4708"
"5135_5135_R","null","RESTRICTED","5135","5135","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic menorrhagia</p><br/><p>The treatment must be in a patient where oral treatments are ineffective.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic menorrhagia</p><br/><p>The treatment must be in a patient where oral treatments are ineffective.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5136_5136_R","null","RESTRICTED","5136","5136","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>Patient must be one in whom surgery is not indicated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>Patient must be one in whom surgery is not indicated.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5137_5137_R","null","RESTRICTED","5137","5137","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>Patient must have had surgery for this condition with incomplete resolution.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>Patient must have had surgery for this condition with incomplete resolution.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5139_5139_R","null","STREAMLINED","5139","5139","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Thiamine deficiency</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Thiamine deficiency</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5140_5140_R","null","RESTRICTED","5140","5140","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>Patient must be an Aboriginal or a Torres Strait Islander person; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>Patient must be an Aboriginal or a Torres Strait Islander person; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Only 2 courses of PBS-subsidised nicotine replacement therapy may be prescribed per 12-month period.</p><p align=""justify"">Benefit is improved if used in conjunction with a comprehensive support and counselling program.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5143_5143_R","null","RESTRICTED","5143","5143","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5172_5172_R","null","RESTRICTED","5172","5172","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of the onset of lactation</p><br/><p>The treatment must occur in the puerperium; AND</p> <p>The treatment must be for medical reasons.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of the onset of lactation</p><br/><p>The treatment must occur in the puerperium; AND</p> <p>The treatment must be for medical reasons.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5174_5174_R","null","RESTRICTED","5174","5174","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Type 1 diabetes</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Type 1 diabetes</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5179_5179_R","null","RESTRICTED","5179","5179","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypocalcaemia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypocalcaemia</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5180_5180_R","null","RESTRICTED","5180","5180","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven calcium malabsorption</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven calcium malabsorption</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5181_5181_R","null","RESTRICTED","5181","5181","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>The condition must be associated with chronic renal failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>The condition must be associated with chronic renal failure.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5182_5182_R","Continuing treatment (6 to 12 months following commencement)","AUTHORITY_REQUIRED","5182","5182","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Obesity</p><br/><p>Continuing treatment (6 to 12 months following commencement)</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must have reduced their inital body weight by 5 kg or 5% (whichever is the lesser) during the period 6 to 12 months following commencement of treatment with this drug; AND</p> <p>The treatment must not exceed 12 months in total from initial application; AND</p> <p>Patient must not receive more than 1 continuous treatment in a lifetime; AND</p> <p>Patient must be receiving, or enrolled to receive, professional dietetic and weight management advice (where this is available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Obesity</p><br/><p>Continuing treatment (6 to 12 months following commencement)</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must have reduced their inital body weight by 5 kg or 5% (whichever is the lesser) during the period 6 to 12 months following commencement of treatment with this drug; AND</p> <p>The treatment must not exceed 12 months in total from initial application; AND</p> <p>Patient must not receive more than 1 continuous treatment in a lifetime; AND</p> <p>Patient must be receiving, or enrolled to receive, professional dietetic and weight management advice (where this is available).</p> <p>The patient should be ideally enrolled in an exercise program and be receiving supplemental vitamins.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5214_5214_R","null","RESTRICTED","5214","5214","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Contraception</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Contraception</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5216_5216_R","null","RESTRICTED","5216","5216","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypomagnesaemia</p> <p>The condition must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypomagnesaemia</p> <p>The condition must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5218_5218_R","null","STREAMLINED","5218","5218","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5221_5221_R","null","STREAMLINED","5221","5221","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Blepharospasm or hemifacial spasm</p><br/><p>Patient must have blepharospasm; or</p> <p>Patient must have hemifacial spasm; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an ophthalmologist; or</p> <p>Must be treated by an otolaryngology head and neck surgeon; or</p> <p>Must be treated by a plastic surgeon; AND</p> <p>Patient must be aged 12 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Contraindications to treatment include known sensitivity to botulinum toxin.</p> <p>Blepharospasm or hemifacial spasm</p><br/><p>Patient must have blepharospasm; or</p> <p>Patient must have hemifacial spasm; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an ophthalmologist; or</p> <p>Must be treated by an otolaryngology head and neck surgeon; or</p> <p>Must be treated by a plastic surgeon; AND</p> <p>Patient must be aged 12 years or older.</p> <p>The units used to express the potency of botulinum toxin preparations currently available for PBS subsidy are not equivalent.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5222_5222_R","null","STREAMLINED","5222","5222","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spasmodic torticollis</p><br/><p>Patient must have spasmodic torticollis; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be as adjunctive therapy to current standard care; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a plastic surgeon; or</p> <p>Must be treated by a rehabilitation specialist; AND</p> <p>Patient must be aged 18 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Contraindications to treatment include known sensitivity to botulinum toxin.</p> <p>Spasmodic torticollis</p><br/><p>Patient must have spasmodic torticollis; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be as adjunctive therapy to current standard care; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a plastic surgeon; or</p> <p>Must be treated by a rehabilitation specialist; AND</p> <p>Patient must be aged 18 years or older.</p> <p>The units used to express the potency of botulinum toxin preparations currently available for PBS subsidy are not equivalent.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5225_5225_R","Management","AUTHORITY_REQUIRED","5225","5225","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solar (actinic) keratosis</p><br/><p>Management</p><br/><p>Patient must require topical drug therapy as field treatment for clinically visible and subclinical lesions where other standard treatments are inappropriate.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Solar (actinic) keratosis</p><br/><p>Management</p><br/><p>Patient must require topical drug therapy as field treatment for clinically visible and subclinical lesions where other standard treatments are inappropriate.</p> <p align=""justify"">Maximum quantity of four tubes (original + 3 repeats) in 12 months.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5226_5226_R","null","STREAMLINED","5226","5226","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>Patient must be 6 years of age or older; AND</p> <p>Patient must be one in whom an enuresis alarm is contraindicated.</p> <p align=""justify"">The reason that an enuresis alarm is contraindicated must be documented in the patient&apos;s medical records when treatment is initiated</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>Patient must be 6 years of age or older; AND</p> <p>Patient must be one in whom an enuresis alarm is contraindicated.</p> <p align=""justify"">The reason that an enuresis alarm is contraindicated must be documented in the patient&apos;s medical records when treatment is initiated</p> <p align=""justify"">Not to be used in preference to enuresis alarms.</p> <p align=""justify"">Only one application per six months will be authorised for the wafers. No more than twice the maximum quantity for the 120 micrograms wafers and no applications for increased maximum quantities for the 240 micrograms wafers will be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5251_5251_R","null","STREAMLINED","5251","5251","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stimulation of follicular development</p><br/><p>Patient must have severe LH deficiency; AND</p> <p>Patient must be receiving medical treatment as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stimulation of follicular development</p><br/><p>Patient must have severe LH deficiency; AND</p> <p>Patient must be receiving medical treatment as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5255_5255_R","null","STREAMLINED","5255","5255","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypoparathyroidism</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypoparathyroidism</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5263_5263_R","Initial treatment","AUTHORITY_REQUIRED","5263","5263","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Obesity</p><br/><p>Initial treatment</p><br/><p>Patient must have a Body Mass Index (BMI) greater than or equal to 35 with no known co-morbidities; or</p> <p>Patient must have a BMI greater than or equal to 30 with 1 or more of the following co-morbidities;(i) diabetes;(ii) ischaemic heart disease;(iii) psychiatric conditions;(iv) hypertension; AND</p> <p>Patient must be receiving, or enrolled to receive, professional dietetic and weight management advice (where this is available); AND</p> <p>The treatment must not exceed 12 months in total from initial application; AND</p> <p>Patient must not receive more than 1 continuous treatment in a lifetime.</p> <p>The prescriber must provide the patient&apos;s initial body weight and BMI at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Obesity</p><br/><p>Initial treatment</p><br/><p>Patient must have a Body Mass Index (BMI) greater than or equal to 35 with no known co-morbidities; or</p> <p>Patient must have a BMI greater than or equal to 30 with 1 or more of the following co-morbidities;(i) diabetes;(ii) ischaemic heart disease;(iii) psychiatric conditions;(iv) hypertension; AND</p> <p>Patient must be receiving, or enrolled to receive, professional dietetic and weight management advice (where this is available); AND</p> <p>The treatment must not exceed 12 months in total from initial application; AND</p> <p>Patient must not receive more than 1 continuous treatment in a lifetime.</p> <p>The prescriber must provide the patient&apos;s initial body weight and BMI at the time of application.</p> <p>The patient should be ideally enrolled in an exercise program and be receiving supplemental vitamins.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5264_5264_R","Continuing treatment (3 to 6 months following commencement)","AUTHORITY_REQUIRED","5264","5264","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Obesity</p><br/><p>Continuing treatment (3 to 6 months following commencement)</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must have reduced their inital body weight by 2.5 kg or 2.5% (whichever is the lesser) during the period 3 to 6 months following commencement of treatment with this drug; AND</p> <p>The treatment must not exceed 12 months in total from initial application; AND</p> <p>Patient must not receive more than 1 continuous treatment in a lifetime; AND</p> <p>Patient must be receiving, or enrolled to receive, professional dietetic and weight management advice (where this is available).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Obesity</p><br/><p>Continuing treatment (3 to 6 months following commencement)</p><br/><p>Patient must have previously been issued with an authority prescription for this drug; AND</p> <p>Patient must have reduced their inital body weight by 2.5 kg or 2.5% (whichever is the lesser) during the period 3 to 6 months following commencement of treatment with this drug; AND</p> <p>The treatment must not exceed 12 months in total from initial application; AND</p> <p>Patient must not receive more than 1 continuous treatment in a lifetime; AND</p> <p>Patient must be receiving, or enrolled to receive, professional dietetic and weight management advice (where this is available).</p> <p>The patient should be ideally enrolled in an exercise program and be receiving supplemental vitamins.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5266_5266_R","null","STREAMLINED","5266","5266","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cranial diabetes insipidus</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cranial diabetes insipidus</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5267_5267_R","null","STREAMLINED","5267","5267","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>Patient must be 6 years of age or older; AND</p> <p>Patient must be one in whom an enuresis alarm is contraindicated.</p> <p align=""justify"">The reason that an enuresis alarm is contraindicated must be documented in the patient&apos;s medical records when treatment is initiated</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Desmopressin nasal spray may be associated with an increased risk of hyponatraemia compared to the oral formulations.</p> <p>Primary nocturnal enuresis</p><br/><p>Patient must be 6 years of age or older; AND</p> <p>Patient must be one in whom an enuresis alarm is contraindicated.</p> <p align=""justify"">The reason that an enuresis alarm is contraindicated must be documented in the patient&apos;s medical records when treatment is initiated</p> <p align=""justify"">Not to be used in preference to enuresis alarms.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5268_5268_R","null","RESTRICTED","5268","5268","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious staphylococcal infection</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious staphylococcal infection</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5289_5289_R","null","RESTRICTED","5289","5289","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic menorrhagia</p><br/><p>The treatment must be in a patient where oral treatments are contraindicated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Idiopathic menorrhagia</p><br/><p>The treatment must be in a patient where oral treatments are contraindicated.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5291_5291_R","null","STREAMLINED","5291","5291","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to breast cancer.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to breast cancer.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5295_5295_R","null","STREAMLINED","5295","5295","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>Patient must be 6 years of age or older; AND</p> <p>Patient must be one in whom an enuresis alarm is contraindicated.</p> <p align=""justify"">The reason that an enuresis alarm is contraindicated must be documented in the patient&apos;s medical records when treatment is initiated</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>Patient must be 6 years of age or older; AND</p> <p>Patient must be one in whom an enuresis alarm is contraindicated.</p> <p align=""justify"">The reason that an enuresis alarm is contraindicated must be documented in the patient&apos;s medical records when treatment is initiated</p> <p align=""justify"">Not to be used in preference to enuresis alarms.</p> <p align=""justify"">Only one application per six months with no more than twice the maximum quantity will be authorised for the tablets.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5296_5296_R","null","RESTRICTED","5296","5296","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ablation of thyroid remnant tissue</p><br/><p>Patient must have undergone a thyroidectomy; AND</p> <p>The treatment must be in combination with radioactive iodine; AND</p> <p>Patient must not have a known metastatic disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ablation of thyroid remnant tissue</p><br/><p>Patient must have undergone a thyroidectomy; AND</p> <p>The treatment must be in combination with radioactive iodine; AND</p> <p>Patient must not have a known metastatic disease.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5298_5298_R","null","RESTRICTED","5298","5298","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious staphylococcal infection</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Severe cholestatic hepatitis has been reported with this drug. Significant risk factors are age, particularly greater than 55 years, and duration of treatment longer than 14 days.</p> <p>Serious staphylococcal infection</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5323_5323_R","null","RESTRICTED","5323","5323","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven glutaric aciduria type 1</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven glutaric aciduria type 1</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5339_5339_R","null","RESTRICTED","5339","5339","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5342_5342_R","null","STREAMLINED","5342","5342","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>Patient must be 6 years of age or older; AND</p> <p>Patient must be refractory to an enuresis alarm.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Desmopressin nasal spray may be associated with an increased risk of hyponatraemia compared to the oral formulations.</p> <p>Primary nocturnal enuresis</p><br/><p>Patient must be 6 years of age or older; AND</p> <p>Patient must be refractory to an enuresis alarm.</p> <p align=""justify"">Not to be used in preference to enuresis alarms.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5357_5357_R","null","RESTRICTED","5357","5357","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>Patient must have had radiotherapy for this condition with incomplete resolution.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>Patient must have had radiotherapy for this condition with incomplete resolution.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5360_5360_R","null","STREAMLINED","5360","5360","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Blepharospasm</p><br/><p>Patient must have blepharospasm; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an ophthalmologist; or</p> <p>Must be treated by an otolaryngology head and neck surgeon; or</p> <p>Must be treated by a plastic surgeon.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Contraindications to treatment include known sensitivity to botulinum toxin.</p> <p>Blepharospasm</p><br/><p>Patient must have blepharospasm; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an ophthalmologist; or</p> <p>Must be treated by an otolaryngology head and neck surgeon; or</p> <p>Must be treated by a plastic surgeon.</p> <p>The units used to express the potency of botulinum toxin preparations currently available for PBS subsidy are not equivalent.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5366_5366_R","null","STREAMLINED","5366","5366","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Alcohol dependence</p><br/><p>The treatment must be part of a comprehensive treatment program with the goal of maintaining abstinence.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Alcohol dependence</p><br/><p>The treatment must be part of a comprehensive treatment program with the goal of maintaining abstinence.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5367_5367_R","Primary treatment","AUTHORITY_REQUIRED","5367","5367","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Superficial basal cell carcinoma</p><br/><p>Primary treatment</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The condition must be one where other standard treatments are inappropriate; AND</p> <p>The condition must require topical drug therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Superficial basal cell carcinoma</p><br/><p>Primary treatment</p><br/><p>The condition must be confirmed by a histological diagnosis; AND</p> <p>The condition must be one where other standard treatments are inappropriate; AND</p> <p>The condition must require topical drug therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5398_5398_R","null","RESTRICTED","5398","5398","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>Patient must be one in whom radiotherapy is not indicated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>Patient must be one in whom radiotherapy is not indicated.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5399_5399_R","null","AUTHORITY_REQUIRED","5399","5399","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Refractory neuropathic pain</p><br/><p>The condition must be unable to be controlled by other drugs.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Refractory neuropathic pain</p><br/><p>The condition must be unable to be controlled by other drugs.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5401_5401_R","null","STREAMLINED","5401","5401","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypocalcaemia</p><br/><p>The condition must be due to renal disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypocalcaemia</p><br/><p>The condition must be due to renal disease.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5402_5402_R","null","STREAMLINED","5402","5402","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5405_5405_R","null","STREAMLINED","5405","5405","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Blepharospasm or hemifacial spasm</p><br/><p>Patient must have blepharospasm; or</p> <p>Patient must have hemifacial spasm; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an ophthalmologist; or</p> <p>Must be treated by an otolaryngology head and neck surgeon; or</p> <p>Must be treated by a plastic surgeon.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Contraindications to treatment include known sensitivity to botulinum toxin.</p> <p>Blepharospasm or hemifacial spasm</p><br/><p>Patient must have blepharospasm; or</p> <p>Patient must have hemifacial spasm; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an ophthalmologist; or</p> <p>Must be treated by an otolaryngology head and neck surgeon; or</p> <p>Must be treated by a plastic surgeon.</p> <p>The units used to express the potency of botulinum toxin preparations currently available for PBS subsidy are not equivalent.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5406_5406_R","null","STREAMLINED","5406","5406","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Spasmodic torticollis</p><br/><p>Patient must have spasmodic torticollis; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be as adjunctive therapy to current standard care; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a plastic surgeon; or</p> <p>Must be treated by a rehabilitation specialist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Contraindications to treatment include known sensitivity to botulinum toxin.</p> <p>Spasmodic torticollis</p><br/><p>Patient must have spasmodic torticollis; AND</p> <p>The treatment must be as monotherapy; or</p> <p>The treatment must be as adjunctive therapy to current standard care; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by a plastic surgeon; or</p> <p>Must be treated by a rehabilitation specialist.</p> <p>The units used to express the potency of botulinum toxin preparations currently available for PBS subsidy are not equivalent.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5409_5409_R","null","STREAMLINED","5409","5409","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urinary incontinence</p><br/><p>The condition must be due to neurogenic detrusor overactivity, as demonstrated by urodynamic study; AND</p> <p>The condition must be inadequately controlled by anti-cholinergic therapy; AND</p> <p>Patient must experience at least 14 episodes of urinary incontinence per week prior to commencement of treatment with Botulinum Toxin Type A Neurotoxin Complex; AND</p> <p>Patient must be willing and able to self-catheterise; AND</p> <p>The treatment must not continue if the patient does not achieve a 50% or greater reduction from baseline in urinary incontinence episodes 6-12 weeks after the first treatment; AND</p> <p>Patient must have multiple sclerosis; or</p> <p>Patient must have a spinal cord injury; or</p> <p>Patient must be aged 18 years or older and have spina bifida; AND</p> <p>Must be treated by a urologist; or</p> <p>Must be treated by a urogynaecologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Contraindications to treatment include known sensitivity to botulinum toxin.</p> <p>Urinary incontinence</p><br/><p>The condition must be due to neurogenic detrusor overactivity, as demonstrated by urodynamic study; AND</p> <p>The condition must be inadequately controlled by anti-cholinergic therapy; AND</p> <p>Patient must experience at least 14 episodes of urinary incontinence per week prior to commencement of treatment with Botulinum Toxin Type A Neurotoxin Complex; AND</p> <p>Patient must be willing and able to self-catheterise; AND</p> <p>The treatment must not continue if the patient does not achieve a 50% or greater reduction from baseline in urinary incontinence episodes 6-12 weeks after the first treatment; AND</p> <p>Patient must have multiple sclerosis; or</p> <p>Patient must have a spinal cord injury; or</p> <p>Patient must be aged 18 years or older and have spina bifida; AND</p> <p>Must be treated by a urologist; or</p> <p>Must be treated by a urogynaecologist.</p> <p>The units used to express the potency of botulinum toxin preparations currently available for PBS subsidy are not equivalent.</p> <p align=""justify"">Special Pricing Arrangements apply.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5411_5411_R","null","RESTRICTED","5411","5411","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary severe restless legs syndrome</p><br/><p>Patient must manifest all 4 diagnostic criteria for Restless Legs Syndrome; AND</p> <p>Patient must have a baseline International Restless Legs Syndrome Rating Scale (IRLSRS) score greater than or equal to 21 points prior to initiation of pramipexole.</p> <p align=""justify"">The date and IRLSRS score must be documented in the patient&apos;s medical records at the time pramipexole treatment is initiated.</p> <p align=""justify"">The diagnostic criteria for Restless Legs Syndrome are:</p><p align=""justify"">(a) An urge to move the legs usually accompanied or caused by unpleasant sensations in the legs; and</p><p align=""justify"">(b) The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting; and</p><p align=""justify"">(c) The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues; and</p><p align=""justify"">(d) The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur during the evening or night.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Episodes of sudden onset of sleep without warning, during activity, have been reported with this drug.</p> <p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p> <p>Primary severe restless legs syndrome</p><br/><p>Patient must manifest all 4 diagnostic criteria for Restless Legs Syndrome; AND</p> <p>Patient must have a baseline International Restless Legs Syndrome Rating Scale (IRLSRS) score greater than or equal to 21 points prior to initiation of pramipexole.</p> <p align=""justify"">The date and IRLSRS score must be documented in the patient&apos;s medical records at the time pramipexole treatment is initiated.</p> <p align=""justify"">The diagnostic criteria for Restless Legs Syndrome are:</p><p align=""justify"">(a) An urge to move the legs usually accompanied or caused by unpleasant sensations in the legs; and</p><p align=""justify"">(b) The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting; and</p><p align=""justify"">(c) The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues; and</p><p align=""justify"">(d) The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur during the evening or night.</p> <p>This drug is not PBS-subsidised for Restless Legs Syndrome secondary to other causes</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5412_5412_R","null","STREAMLINED","5412","5412","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>Patient must be 6 years of age or older; AND</p> <p>Patient must be refractory to an enuresis alarm.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>Patient must be 6 years of age or older; AND</p> <p>Patient must be refractory to an enuresis alarm.</p> <p align=""justify"">Not to be used in preference to enuresis alarms.</p> <p align=""justify"">Only one application per six months will be authorised for the wafers. No more than twice the maximum quantity for the 120 micrograms wafers and no applications for increased maximum quantities for the 240 micrograms wafers will be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5413_5413_R","null","STREAMLINED","5413","5413","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>Patient must be 6 years of age or older; AND</p> <p>Patient must be refractory to an enuresis alarm.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary nocturnal enuresis</p><br/><p>Patient must be 6 years of age or older; AND</p> <p>Patient must be refractory to an enuresis alarm.</p> <p align=""justify"">Not to be used in preference to enuresis alarms.</p> <p align=""justify"">Only one application per six months with no more than twice the maximum quantity will be authorised for the tablets.</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5414_5414_R","null","RESTRICTED","5414","5414","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious staphylococcal infection</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Severe cholestatic hepatitis has been reported with this drug. Significant risk factors are age, particularly greater than 55 years, and duration of treatment longer than 14 days.</p> <p>Serious staphylococcal infection</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5415_5415_R","null","RESTRICTED","5415","5415","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious staphylococcal infection</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Serious staphylococcal infection</p>","N","N","N","IMMEDIATE","ALL","N","2015-09-01","N","4708"
"5444_5444_R","null","RESTRICTED","5444","5444","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastro-oesophageal reflux disease</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastro-oesophageal reflux disease</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5446_5446_R","null","RESTRICTED","5446","5446","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Septicaemia, suspected</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Septicaemia, suspected</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5450_5450_R","null","STREAMLINED","5450","5450","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe cryopyrin associated periodic syndromes (CAPS)</p><br/><p>Must be treated by a rheumatologist or in consultation with a rheumatologist; or</p> <p>Must be treated by a clinical immunologist or in consultation with a clinical immunologist.</p> <p align=""justify"">A diagnosis of CAPS must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe cryopyrin associated periodic syndromes (CAPS)</p><br/><p>Must be treated by a rheumatologist or in consultation with a rheumatologist; or</p> <p>Must be treated by a clinical immunologist or in consultation with a clinical immunologist.</p> <p align=""justify"">A diagnosis of CAPS must be documented in the patient&apos;s medical records.</p> <p>This drug is not PBS-subsidised for conditions other than CAPS.</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5452_5452_R","Continuing treatment","STREAMLINED","5452","5452","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received an initial authority prescription for panitumumab for first-line treatment of RAS wild-type metastatic colorectal cancer; AND</p> <p>Patient must not have progressive disease; AND</p> <p>The treatment must be in combination with first-line chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p/><p align=""justify"">Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.</p><p/> <p/><p align=""justify"">Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received an initial authority prescription for panitumumab for first-line treatment of RAS wild-type metastatic colorectal cancer; AND</p> <p>Patient must not have progressive disease; AND</p> <p>The treatment must be in combination with first-line chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p/><p align=""justify"">Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.</p><p/> <p/><p align=""justify"">Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.</p><p/> <p align=""justify"">Special Pricing Arrangements apply.</p> <p/><p align=""justify"">Panitimumab is not PBS-subsidised for use in combination with another anti-EGFR antibody or in combination with an anti-VEGF antibody. </p><p/> <p align=""justify"">This drug is not PBS-subsidised when chemotherapy partners are switched whilst maintaining an anti-EGFR antibody backbone in the face of progressive disease.</p> <p align=""justify"">The treatment must not exceed a single course of therapy with this drug for metastatic colorectal cancer in a patient&apos;s lifetime.</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5466_5466_R","null","STREAMLINED","5466","5466","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic renal disease</p><br/><p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic renal disease</p><br/><p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5470_5470_R","null","RESTRICTED","5470","5470","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gram-positive coccal infections</p><br/><p>The condition must not be able to be safely and effectively treated with a penicillin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gram-positive coccal infections</p><br/><p>The condition must not be able to be safely and effectively treated with a penicillin.</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5487_5487_R","null","RESTRICTED","5487","5487","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gram-positive coccal infections</p><br/><p>The condition must not be able to be safely and effectively treated with a penicillin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gram-positive coccal infections</p><br/><p>The condition must not be able to be safely and effectively treated with a penicillin.</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5490_5490_R","null","RESTRICTED","5490","5490","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Septicaemia, proven</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Septicaemia, proven</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5498_5498_R","null","RESTRICTED","5498","5498","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pseudomonas aeruginosa infection</p><br/><p>Patient must have cystic fibrosis; AND</p> <p>The treatment must be systemic.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pseudomonas aeruginosa infection</p><br/><p>Patient must have cystic fibrosis; AND</p> <p>The treatment must be systemic.</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5506_5506_R","null","STREAMLINED","5506","5506","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypomagnesaemia</p><br/><p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypomagnesaemia</p><br/><p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5512_5512_R","null","RESTRICTED","5512","5512","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Scleroderma oesophagus</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Scleroderma oesophagus</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5519_5519_R","null","RESTRICTED","5519","5519","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5526_5526_R","Initial Treatment","STREAMLINED","5526","5526","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial Treatment</p><br/><p>Patient must have RAS wild-type metastatic colorectal cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must be previously untreated; AND</p> <p>The treatment must be in combination with first-line chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p/><p align=""justify"">Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.</p><p/> <p/><p align=""justify"">Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Initial Treatment</p><br/><p>Patient must have RAS wild-type metastatic colorectal cancer; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must be previously untreated; AND</p> <p>The treatment must be in combination with first-line chemotherapy; AND</p> <p>The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition.</p> <p/><p align=""justify"">Patients who have progressive disease on cetuximab are not eligible to receive PBS-subsidised panitumumab.</p><p/> <p/><p align=""justify"">Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised panitumumab.</p><p/> <p align=""justify"">Special Pricing Arrangements apply.</p> <p/><p align=""justify"">Panitimumab is not PBS-subsidised for use in combination with another anti-EGFR antibody or in combination with an anti-VEGF antibody. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5529_5529_R","null","RESTRICTED","5529","5529","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Zollinger-Ellison syndrome</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Zollinger-Ellison syndrome</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5530_5530_R","Initiation and stabilisation","STREAMLINED","5530","5530","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>Initiation and stabilisation</p><br/><p>The condition must not be adequately controlled by calcium; AND</p> <p>Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or</p> <p>The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND</p> <p>The treatment must not be used in combination with any other non-calcium phosphate binding agents; AND</p> <p>Patient must be undergoing dialysis for chronic kidney disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>Initiation and stabilisation</p><br/><p>The condition must not be adequately controlled by calcium; AND</p> <p>Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or</p> <p>The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND</p> <p>The treatment must not be used in combination with any other non-calcium phosphate binding agents; AND</p> <p>Patient must be undergoing dialysis for chronic kidney disease.</p>","N","N","N","IMMEDIATE","ALL","N","2015-10-01","N","4708"
"5533_5533_R","null","RESTRICTED","5533","5533","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tyrosinaemia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tyrosinaemia</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5534_5534_R","null","RESTRICTED","5534","5534","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pyridoxine non-responsive homocystinuria</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pyridoxine non-responsive homocystinuria</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5535_5535_R","null","AUTHORITY_REQUIRED","5535","5535","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic suppurative otitis media</p><br/><p>Patient must be less than 18 years of age; AND</p> <p>Patient must have a grommet in situ.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic suppurative otitis media</p><br/><p>Patient must be less than 18 years of age; AND</p> <p>Patient must have a grommet in situ.</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5540_5540_R","null","RESTRICTED","5540","5540","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary and relapsing superficial urothelial carcinoma of the bladder</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary and relapsing superficial urothelial carcinoma of the bladder</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5542_5542_R","null","RESTRICTED","5542","5542","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Propionic acidaemia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Propionic acidaemia</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5551_5551_R","null","AUTHORITY_REQUIRED","5551","5551","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic suppurative otitis media</p><br/><p>Patient must be less than 18 years of age; AND</p> <p>Patient must have perforation of the tympanic membrane.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic suppurative otitis media</p><br/><p>Patient must be less than 18 years of age; AND</p> <p>Patient must have perforation of the tympanic membrane.</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5553_5553_R","null","RESTRICTED","5553","5553","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Insomnia</p><br/><p>The treatment must be for the short-term.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Insomnia</p><br/><p>The treatment must be for the short-term.</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5554_5554_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","5554","5554","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of cardiac allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of cardiac allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5559_5559_R","null","RESTRICTED","5559","5559","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pyridoxine non-responsive homocystinuria</p><br/><p>Patient must be an infant or a very young child.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pyridoxine non-responsive homocystinuria</p><br/><p>Patient must be an infant or a very young child.</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5560_5560_R","null","RESTRICTED","5560","5560","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Methylmalonic acidaemia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Methylmalonic acidaemia</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5561_5561_R","null","RESTRICTED","5561","5561","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Glycogen storage disease</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Glycogen storage disease</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5565_5565_R","null","RESTRICTED","5565","5565","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urinary symptoms</p><br/><p>The treatment must be for when antibiotic or other therapy alone is inappropriate.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urinary symptoms</p><br/><p>The treatment must be for when antibiotic or other therapy alone is inappropriate.</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5569_5569_R","null","STREAMLINED","5569","5569","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of rejection in patients following organ or tissue transplantation</p><br/><p>The treatment must be under the supervision and direction of a transplant unit; AND</p> <p>The treatment must include initiation, stabilisation, and review of therapy as required.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of rejection in patients following organ or tissue transplantation</p><br/><p>The treatment must be under the supervision and direction of a transplant unit; AND</p> <p>The treatment must include initiation, stabilisation, and review of therapy as required.</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5571_5571_R","null","RESTRICTED","5571","5571","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Maple syrup urine disease</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Maple syrup urine disease</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5590_5590_R","null","AUTHORITY_REQUIRED","5590","5590","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erectile dysfunction</p><br/><p>The condition must be vasculogenic; or</p> <p>The condition must be psychogenic; or</p> <p>The condition must be neurogenic; AND</p> <p>Patient must have a specific accepted war-caused or service-related disability; AND</p> <p>Patient must be male.</p> <p>Authorisation will not be given for any additional prescriptions within 6 months or for any increased quantities or repeats.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Erectile dysfunction</p><br/><p>The condition must be vasculogenic; or</p> <p>The condition must be psychogenic; or</p> <p>The condition must be neurogenic; AND</p> <p>Patient must have a specific accepted war-caused or service-related disability; AND</p> <p>Patient must be male.</p> <p>Authorisation will not be given for any additional prescriptions within 6 months or for any increased quantities or repeats.</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5593_5593_R","null","AUTHORITY_REQUIRED","5593","5593","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic suppurative otitis media</p><br/><p>Patient must be an Aboriginal or a Torres Strait Islander person; AND</p> <p>Patient must be aged 1 month or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic suppurative otitis media</p><br/><p>Patient must be an Aboriginal or a Torres Strait Islander person; AND</p> <p>Patient must be aged 1 month or older.</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5597_5597_R","null","RESTRICTED","5597","5597","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary and relapsing superficial urothelial carcinoma of the bladder</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Primary and relapsing superficial urothelial carcinoma of the bladder</p>","N","N","N","IMMEDIATE","ALL","N","2015-11-01","N","4708"
"5607_5607_R","null","STREAMLINED","5607","5607","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hydatid disease</p><br/><p>The treatment must be in conjunction with surgery; or</p> <p>The treatment must be used when a surgical cure cannot be achieved; or</p> <p>The treatment must be used when surgery cannot be used.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hydatid disease</p><br/><p>The treatment must be in conjunction with surgery; or</p> <p>The treatment must be used when a surgical cure cannot be achieved; or</p> <p>The treatment must be used when surgery cannot be used.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5613_5613_R","null","RESTRICTED","5613","5613","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5614_5614_R","null","AUTHORITY_REQUIRED","5614","5614","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone or joint infection</p><br/><p>The condition must be suspected or proven to be caused by gram-negative bacteria resistant to all other appropriate antimicrobials; or</p> <p>The condition must be suspected or proven to be caused by gram-positive bacteria resistant to all other appropriate antimicrobials.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone or joint infection</p><br/><p>The condition must be suspected or proven to be caused by gram-negative bacteria resistant to all other appropriate antimicrobials; or</p> <p>The condition must be suspected or proven to be caused by gram-positive bacteria resistant to all other appropriate antimicrobials.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5615_5615_R","null","AUTHORITY_REQUIRED","5615","5615","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prostatitis</p><br/><p>The condition must be suspected or proven to be caused by gram-negative bacteria resistant to all other appropriate antimicrobials; or</p> <p>The condition must be suspected or proven to be caused by gram-positive bacteria resistant to all other appropriate antimicrobials.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prostatitis</p><br/><p>The condition must be suspected or proven to be caused by gram-negative bacteria resistant to all other appropriate antimicrobials; or</p> <p>The condition must be suspected or proven to be caused by gram-positive bacteria resistant to all other appropriate antimicrobials.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5637_5637_R","null","RESTRICTED","5637","5637","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Trachoma</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Trachoma</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5638_5638_R","null","RESTRICTED","5638","5638","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bordetella pertussis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bordetella pertussis</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5640_5640_R","null","RESTRICTED","5640","5640","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be paraplegic or quadriplegic or have severe neurogenic impairment of bowel function.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be paraplegic or quadriplegic or have severe neurogenic impairment of bowel function.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5648_5648_R","null","RESTRICTED","5648","5648","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients requiring doses greater than 20 mg per week</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients requiring doses greater than 20 mg per week</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5659_5659_R","null","STREAMLINED","5659","5659","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schistosomiasis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schistosomiasis</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5663_5663_R","null","RESTRICTED","5663","5663","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical mycobacterial infections</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Atypical mycobacterial infections</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5666_5666_R","null","AUTHORITY_REQUIRED","5666","5666","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gonorrhoea</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gonorrhoea</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5669_5669_R","null","AUTHORITY_REQUIRED","5669","5669","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Wounds</p><br/><p>Patient must have a wound where there is evidence of critical colonisation; or</p> <p>Patient must have a well-assessed chronic wound that has not responded to conventional dressings.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Wounds</p><br/><p>Patient must have a wound where there is evidence of critical colonisation; or</p> <p>Patient must have a well-assessed chronic wound that has not responded to conventional dressings.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5672_5672_R","null","RESTRICTED","5672","5672","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mucositis</p><br/><p>The condition must be radiation induced.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mucositis</p><br/><p>The condition must be radiation induced.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5680_5680_R","null","STREAMLINED","5680","5680","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tapeworm infestation</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tapeworm infestation</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5685_5685_R","null","RESTRICTED","5685","5685","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anorectal congenital abnormalities</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anorectal congenital abnormalities</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5686_5686_R","null","RESTRICTED","5686","5686","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>This drug is not PBS-subsidised for administration with oral 5-HT3 antagonists.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5687_5687_R","null","AUTHORITY_REQUIRED","5687","5687","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Respiratory tract infection</p><br/><p>The condition must be proven or suspected to be caused by Pseudomonas aeruginosa; AND</p> <p>Patient must be severely immunocompromised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Respiratory tract infection</p><br/><p>The condition must be proven or suspected to be caused by Pseudomonas aeruginosa; AND</p> <p>Patient must be severely immunocompromised.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5688_5688_R","null","AUTHORITY_REQUIRED","5688","5688","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>The condition must be proven to be due to Pseudomonas aeruginosa resistant to all other oral antimicrobials; or</p> <p>The condition must be proven to be due to other gram-negative bacteria resistant to all other oral antimicrobials.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>The condition must be proven to be due to Pseudomonas aeruginosa resistant to all other oral antimicrobials; or</p> <p>The condition must be proven to be due to other gram-negative bacteria resistant to all other oral antimicrobials.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5689_5689_R","null","AUTHORITY_REQUIRED","5689","5689","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epididymo-orchitis</p><br/><p>The condition must be suspected or proven to be caused by gram-negative bacteria resistant to all other appropriate antimicrobials; or</p> <p>The condition must be suspected or proven to be caused by gram-positive bacteria resistant to all other appropriate antimicrobials.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Epididymo-orchitis</p><br/><p>The condition must be suspected or proven to be caused by gram-negative bacteria resistant to all other appropriate antimicrobials; or</p> <p>The condition must be suspected or proven to be caused by gram-positive bacteria resistant to all other appropriate antimicrobials.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5695_5695_R","null","AUTHORITY_REQUIRED","5695","5695","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Wounds</p><br/><p>Patient must have a wound where there is evidence of critical colonisation; or</p> <p>Patient must have a well-assessed chronic wound that has not responded to conventional dressings.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Wounds</p><br/><p>Patient must have a wound where there is evidence of critical colonisation; or</p> <p>Patient must have a well-assessed chronic wound that has not responded to conventional dressings.</p> <p align=""justify"">Hartmann wound dressings are available through HARTMANN and Independence Australia only. If you would like to order Hartmann Wound Care products, please call HARTMANN customer service on 1800 805 839 or Independence Australia on 1300 788 855.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5697_5697_R","null","RESTRICTED","5697","5697","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent streptococcal infections (including rheumatic fever)</p><br/><p>The treatment must be for prophylaxis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent streptococcal infections (including rheumatic fever)</p><br/><p>The treatment must be for prophylaxis.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5701_5701_R","null","RESTRICTED","5701","5701","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaerobic infections</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaerobic infections</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5702_5702_R","null","RESTRICTED","5702","5702","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaerobic infections</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaerobic infections</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5712_5712_R","null","STREAMLINED","5712","5712","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Strongyloidiasis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Strongyloidiasis</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5716_5716_R","null","RESTRICTED","5716","5716","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endophthalmitis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endophthalmitis</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5717_5717_R","null","RESTRICTED","5717","5717","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endocarditis</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be hypersensitive to penicillin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endocarditis</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be hypersensitive to penicillin.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5720_5720_R","null","RESTRICTED","5720","5720","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5721_5721_R","null","RESTRICTED","5721","5721","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.</p>","N","N","N","IMMEDIATE","ALL","Y","2015-12-01","N","4708"
"5722_5722_R","null","AUTHORITY_REQUIRED","5722","5722","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bacterial gastroenteritis</p><br/><p>Patient must be severely immunocompromised.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bacterial gastroenteritis</p><br/><p>Patient must be severely immunocompromised.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5732_5732_R","null","RESTRICTED","5732","5732","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mucositis</p><br/><p>The condition must be radiation induced.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mucositis</p><br/><p>The condition must be radiation induced.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5744_5744_R","null","AUTHORITY_REQUIRED","5744","5744","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute bacterial enterocolitis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute bacterial enterocolitis</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5745_5745_R","null","AUTHORITY_REQUIRED","5745","5745","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Terminal disease</p><br/><p>The treatment must be for the short-term; AND</p> <p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Terminal disease</p><br/><p>The treatment must be for the short-term; AND</p> <p>Patient must be receiving palliative care.</p> <p align=""justify"">This drug should not be used as the first line of treatment.</p> <p align=""justify"">Other PBS-listed benzodiazepines should have been adequately tried and found to be ineffective or inappropriate.</p> <p align=""justify"">Authorities for increased quantities and/or repeats may be granted to patients with terminal disease, and other patients who have been shown to be dependent on this item by an unsuccessful attempt at gradual withdrawal.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5753_5753_R","null","AUTHORITY_REQUIRED","5753","5753","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Wounds</p><br/><p>Patient must have a wound where there is evidence of critical colonisation; or</p> <p>Patient must have a well-assessed chronic wound that has not responded to conventional dressings.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Wounds</p><br/><p>Patient must have a wound where there is evidence of critical colonisation; or</p> <p>Patient must have a well-assessed chronic wound that has not responded to conventional dressings.</p> <p align=""left"">Smith &amp; Nephew products are distributed via the three major wholesalers, API, Sigma and Symbion. To best ensure product availability at RPBS agreed prices, please order from one of these suppliers. In the event that your preferred wholesaler cannot supply, please contact Smith &amp; Nephew Customer Service on 13 13 60. Smith &amp; Nephew cannot ensure RPBS agreed pricing from distributors other than those aforementioned.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5755_5755_R","null","AUTHORITY_REQUIRED","5755","5755","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Wounds</p><br/><p>Patient must have a wound where there is evidence of critical colonisation; or</p> <p>Patient must have a well-assessed chronic wound that has not responded to conventional dressings.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Wounds</p><br/><p>Patient must have a wound where there is evidence of critical colonisation; or</p> <p>Patient must have a well-assessed chronic wound that has not responded to conventional dressings.</p> <p align=""justify"">Coloplast dressings are available via a range of distributors. However, Coloplast&apos;s principal agreement to ensure correct RPBS Price to Pharmacy and ready supply has been secured with Independence Australia on 1300 788 855 and BrightSky on 1300 290 400. Please note that Coloplast is unable to guarantee ready supply or rebate for price differences on purchases outside these distributors.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5756_5756_R","null","AUTHORITY_REQUIRED","5756","5756","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Wounds</p><br/><p>Patient must have a wound where there is evidence of critical colonisation; or</p> <p>Patient must have a well-assessed chronic wound that has not responded to conventional dressings.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Wounds</p><br/><p>Patient must have a wound where there is evidence of critical colonisation; or</p> <p>Patient must have a well-assessed chronic wound that has not responded to conventional dressings.</p> <p align=""justify"">Molnlycke Health Care products are distributed through leading pharmacy distributors. To best ensure product availability at the RPBS agreed prices, special arrangements have been made with API and Independence Australia Health Solutions (IAHS). IAHS orders can be placed on: Tel: 1300 788 855; or Email: <u>customerservice@independenceaustralia.com</u>. Molnlycke Health Care is not able to ensure product availability or pricing on listed products beyond these two suppliers.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5769_5769_R","null","RESTRICTED","5769","5769","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>The treatment must be initiated in a hospital; AND</p> <p>The condition must be one in which vancomycin is an appropriate antibiotic.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection</p><br/><p>The treatment must be initiated in a hospital; AND</p> <p>The condition must be one in which vancomycin is an appropriate antibiotic.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5775_5775_R","null","RESTRICTED","5775","5775","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5776_5776_R","null","RESTRICTED","5776","5776","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Terminal malignant neoplasia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Terminal malignant neoplasia</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5778_5778_R","null","RESTRICTED","5778","5778","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.</p>","N","N","N","IMMEDIATE","ALL","Y","2015-12-01","N","4708"
"5780_5780_R","null","AUTHORITY_REQUIRED","5780","5780","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Perichondritis of the pinna</p><br/><p>The condition must be suspected or proven to be caused by gram-negative bacteria resistant to all other appropriate antimicrobials; or</p> <p>The condition must be suspected or proven to be caused by gram-positive bacteria resistant to all other appropriate antimicrobials.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Perichondritis of the pinna</p><br/><p>The condition must be suspected or proven to be caused by gram-negative bacteria resistant to all other appropriate antimicrobials; or</p> <p>The condition must be suspected or proven to be caused by gram-positive bacteria resistant to all other appropriate antimicrobials.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5795_5795_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","5795","5795","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5797_5797_R","null","STREAMLINED","5797","5797","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hookworm infestation</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hookworm infestation</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5801_5801_R","null","RESTRICTED","5801","5801","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endocarditis</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be hypersensitive to penicillin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endocarditis</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be hypersensitive to penicillin.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5803_5803_R","null","RESTRICTED","5803","5803","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Upper and lower respiratory tract infections</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Upper and lower respiratory tract infections</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5804_5804_R","null","RESTRICTED","5804","5804","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Megacolon</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Megacolon</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5805_5805_R","null","RESTRICTED","5805","5805","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>This drug is not PBS-subsidised for administration with oral 5-HT3 antagonists.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5806_5806_R","null","AUTHORITY_REQUIRED","5806","5806","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complicated urinary tract infection</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complicated urinary tract infection</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5817_5817_R","null","STREAMLINED","5817","5817","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Whipworm infestation</p><br/><p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Whipworm infestation</p><br/><p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","N","N","N","IMMEDIATE","ALL","N","2015-12-01","N","4708"
"5819_5819_R","null","RESTRICTED","5819","5819","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5823_5823_R","null","RESTRICTED","5823","5823","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anorectal congenital abnormalities</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anorectal congenital abnormalities</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5824_5824_R","null","RESTRICTED","5824","5824","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5832_5832_R","null","RESTRICTED","5832","5832","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infections where resistance to amoxicillin is proven</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Hepatotoxicity has been reported with this drug.</p> <p>Infections where resistance to amoxicillin is proven</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5833_5833_R","null","RESTRICTED","5833","5833","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection where resistance to amoxicillin is suspected</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Hepatotoxicity has been reported with this drug.</p> <p>Infection where resistance to amoxicillin is suspected</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5835_5835_R","null","RESTRICTED","5835","5835","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5836_5836_R","null","RESTRICTED","5836","5836","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe disabling pain</p><br/><p>The condition must be unresponsive to non-opioid analgesics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">The risk of drug dependence is high.</p> <p>Chronic severe disabling pain</p><br/><p>The condition must be unresponsive to non-opioid analgesics.</p> <p align=""justify"">Authorities for increased maximum quantities and/or repeats will be granted only for:</p><p align=""justify"">(i) chronic severe disabling pain associated with proven malignant neoplasia; or</p><p align=""justify"">(ii) chronic severe disabling pain where treatment has been initiated by a specialist with appropriate expertise in pain management.</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5843_5843_R","null","RESTRICTED","5843","5843","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic bronchitis</p><br/><p>Patient must have acute exacerbations of the condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic bronchitis</p><br/><p>Patient must have acute exacerbations of the condition.</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5845_5845_R","null","RESTRICTED","5845","5845","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5846_5846_R","null","RESTRICTED","5846","5846","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5851_5851_R","null","RESTRICTED","5851","5851","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Terminal malignant neoplasia</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Terminal malignant neoplasia</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5852_5852_R","null","RESTRICTED","5852","5852","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5855_5855_R","null","RESTRICTED","5855","5855","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gonorrhoea</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gonorrhoea</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5863_5863_R","null","AUTHORITY_REQUIRED","5863","5863","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection suspected or proven to be due to a susceptible organism</p><br/><p>The treatment must be for patients who require a liquid formulation and in whom the syrup formulations are unsuitable.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection suspected or proven to be due to a susceptible organism</p><br/><p>The treatment must be for patients who require a liquid formulation and in whom the syrup formulations are unsuitable.</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5865_5865_R","null","RESTRICTED","5865","5865","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5866_5866_R","null","RESTRICTED","5866","5866","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Megacolon</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Megacolon</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5867_5867_R","null","RESTRICTED","5867","5867","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cellulitis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cellulitis</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5871_5871_R","null","RESTRICTED","5871","5871","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Persistent pain</p><br/><p>The condition must be associated with osteoarthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Persistent pain</p><br/><p>The condition must be associated with osteoarthritis.</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5879_5879_R","null","RESTRICTED","5879","5879","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5884_5884_R","null","RESTRICTED","5884","5884","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5885_5885_R","null","RESTRICTED","5885","5885","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5893_5893_R","null","RESTRICTED","5893","5893","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infection where resistance to amoxicillin is suspected</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Hepatotoxicity has been reported with this drug.</p> <p>Infection where resistance to amoxicillin is suspected</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5894_5894_R","null","RESTRICTED","5894","5894","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infections where resistance to amoxicillin is proven</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Hepatotoxicity has been reported with this drug.</p> <p>Infections where resistance to amoxicillin is proven</p>","N","N","N","IMMEDIATE","ALL","N","2016-01-01","N","4708"
"5901_5901_R","null","STREAMLINED","5901","5901","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>Patient must have achieved symptom control on octreotide immediate release injections; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>Patient must have achieved symptom control on octreotide immediate release injections; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2016-02-01","N","4708"
"5906_5906_R","null","STREAMLINED","5906","5906","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vasoactive intestinal peptide secreting tumour (VIPoma)</p><br/><p>Patient must have achieved symptom control on octreotide immediate release injections; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vasoactive intestinal peptide secreting tumour (VIPoma)</p><br/><p>Patient must have achieved symptom control on octreotide immediate release injections; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2016-02-01","N","4708"
"5913_5913_R","null","AUTHORITY_REQUIRED","5913","5913","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Refractory phobic or anxiety states</p><br/><p>The treatment must be for the short-term.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Refractory phobic or anxiety states</p><br/><p>The treatment must be for the short-term.</p> <p align=""justify"">This drug should not be used as the first line of treatment.</p> <p align=""justify"">Other PBS-listed benzodiazepines should have been adequately tried and found to be ineffective or inappropriate.</p> <p align=""justify"">Authorities for increased quantities and/or repeats may be granted to patients with terminal disease, and other patients who have been shown to be dependent on this item by an unsuccessful attempt at gradual withdrawal.</p>","N","N","N","IMMEDIATE","ALL","N","2016-02-01","N","4708"
"5914_5914_R","null","STREAMLINED","5914","5914","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Thalidomide is a category X drug and must not be given to pregnant women. Pregnancy in female patients or in the partners of male patients must be avoided during treatment and for 1 month after cessation of treatment.</p> <p>Multiple myeloma</p> <p>Patients receiving thalidomide under the PBS listing must be registered in the i-access risk management program.</p>","N","N","N","IMMEDIATE","ALL","N","2016-02-01","N","4708"
"5936_5936_R","null","STREAMLINED","5936","5936","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Initial moderate to severe genital herpes</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Initial moderate to severe genital herpes</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> <p align=""justify"">Aciclovir 200 mg is not PBS-subsidised for chickenpox, herpes zoster or herpes simplex infections other than genital herpes.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p align=""justify"">For item codes 1003T and 1555W, pharmaceutical benefits that have the form tablet 200 mg are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5938_5938_R","null","RESTRICTED","5938","5938","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Megaloblastic anaemias</p><br/><p>The condition must be a result of folic acid deficiency from the use of folic acid antagonists.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Megaloblastic anaemias</p><br/><p>The condition must be a result of folic acid deficiency from the use of folic acid antagonists.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5943_5943_R","null","STREAMLINED","5943","5943","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes zoster</p><br/><p>Patient must be immunocompromised; AND</p> <p>The treatment must be administered within 72 hours of the onset of the rash.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes zoster</p><br/><p>Patient must be immunocompromised; AND</p> <p>The treatment must be administered within 72 hours of the onset of the rash.</p> <p align=""justify"">This drug is only effective if commenced within 72 hours of onset of rash.</p> <p align=""justify"">Famciclovir 500 mg is not PBS-subsidised for chickenpox.</p> <p align=""justify"">Famciclovir 500 mg is not PBS-subsidised for herpes zoster, genital herpes or other herpes simplex infections in immunocompetent patients.</p> <p align=""justify"">No applications for repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5947_5947_R","Episodic treatment","STREAMLINED","5947","5947","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe oral or labial herpes</p><br/><p>Episodic treatment</p><br/><p>Patient must have HIV infection; AND</p> <p>Patient must have a CD4 cell count of less than 500 million per litre.</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe oral or labial herpes</p><br/><p>Episodic treatment</p><br/><p>Patient must have HIV infection; AND</p> <p>Patient must have a CD4 cell count of less than 500 million per litre.</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> <p align=""justify"">Famciclovir 500 mg is not PBS-subsidised for chickenpox.</p> <p align=""justify"">Famciclovir 500 mg is not PBS-subsidised for herpes zoster, genital herpes or other herpes simplex infections in immunocompetent patients.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5948_5948_R","Suppressive therapy","STREAMLINED","5948","5948","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe oral or labial herpes</p><br/><p>Suppressive therapy</p><br/><p>Patient must have HIV infection; AND</p> <p>Patient must have CD4 cell counts of less than 150 million per litre.</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe oral or labial herpes</p><br/><p>Suppressive therapy</p><br/><p>Patient must have HIV infection; AND</p> <p>Patient must have CD4 cell counts of less than 150 million per litre.</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> <p align=""justify"">Famciclovir 500 mg is not PBS-subsidised for chickenpox.</p> <p align=""justify"">Famciclovir 500 mg is not PBS-subsidised for herpes zoster, genital herpes or other herpes simplex infections in immunocompetent patients.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5949_5949_R","Suppressive therapy","STREAMLINED","5949","5949","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe oral or labial herpes</p><br/><p>Suppressive therapy</p><br/><p>Patient must have HIV infection; AND</p> <p>Patient must present with other opportunistic infections or AIDS defining tumours.</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe oral or labial herpes</p><br/><p>Suppressive therapy</p><br/><p>Patient must have HIV infection; AND</p> <p>Patient must present with other opportunistic infections or AIDS defining tumours.</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> <p align=""justify"">Famciclovir 500 mg is not PBS-subsidised for chickenpox.</p> <p align=""justify"">Famciclovir 500 mg is not PBS-subsidised for herpes zoster, genital herpes or other herpes simplex infections in immunocompetent patients.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5951_5951_R","null","STREAMLINED","5951","5951","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes zoster</p><br/><p>The treatment must be administered within 72 hours of the onset of the rash.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes zoster</p><br/><p>The treatment must be administered within 72 hours of the onset of the rash.</p> <p align=""justify"">This drug is only effective if commenced within 72 hours of onset of rash.</p> <p align=""justify"">Famciclovir 250 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.</p> <p align=""justify"">No applications for repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5952_5952_R","null","AUTHORITY_REQUIRED","5952","5952","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Preservation of bone mineral density</p><br/><p>Patient must be on long-term glucocorticoid therapy; AND</p> <p>Patient must be undergoing continuous treatment with a dose equal to or greater than 7.5 mg of prednisone or equivalent per day; AND</p> <p>Patient must be osteopenic (bone mineral density t-score of less than -1.0).</p> <p>Prescribers need to demonstrate that the patient has been on continuous therapy for 3 months or more.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Preservation of bone mineral density</p><br/><p>Patient must be on long-term glucocorticoid therapy; AND</p> <p>Patient must be undergoing continuous treatment with a dose equal to or greater than 7.5 mg of prednisone or equivalent per day; AND</p> <p>Patient must be osteopenic (bone mineral density t-score of less than -1.0).</p> <p>Prescribers need to demonstrate that the patient has been on continuous therapy for 3 months or more.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5954_5954_R","Episodic treatment or suppressive therapy","STREAMLINED","5954","5954","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment or suppressive therapy</p><br/><p>Patient must be immunocompromised.</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment or suppressive therapy</p><br/><p>Patient must be immunocompromised.</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> <p align=""justify"">Famciclovir 500 mg is not PBS-subsidised for chickenpox.</p> <p align=""justify"">Famciclovir 500 mg is not PBS-subsidised for herpes zoster, genital herpes or other herpes simplex infections in immunocompetent patients.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5959_5959_R","null","STREAMLINED","5959","5959","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes zoster ophthalmicus</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes zoster ophthalmicus</p> <p align=""justify"">This drug is only effective if commenced within 72 hours of onset of rash.</p> <p align=""justify"">Aciclovir 800 mg is not PBS-subsidised for herpes simplex or chickenpox.</p> <p align=""justify"">No applications for repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5960_5960_R","null","STREAMLINED","5960","5960","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Initial moderate to severe genital herpes</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Initial moderate to severe genital herpes</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> <p align=""justify"">Valaciclovir 500 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5961_5961_R","Episodic treatment","STREAMLINED","5961","5961","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Episodic treatment</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> <p align=""justify"">Valaciclovir 500 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5962_5962_R","null","STREAMLINED","5962","5962","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes zoster</p><br/><p>The treatment must be administered within 72 hours of the onset of the rash.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes zoster</p><br/><p>The treatment must be administered within 72 hours of the onset of the rash.</p> <p align=""justify"">This drug is only effective if commenced within 72 hours of onset of rash.</p> <p align=""justify"">Valaciclovir 500 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.</p> <p align=""justify"">No applications for repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5964_5964_R","null","RESTRICTED","5964","5964","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes simplex keratitis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes simplex keratitis</p>","N","N","N","IMMEDIATE","ALL","N","2019-04-01","N","4708"
"5967_5967_R","null","STREAMLINED","5967","5967","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes zoster</p><br/><p>The treatment must be administered within 72 hours of the onset of the rash.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes zoster</p><br/><p>The treatment must be administered within 72 hours of the onset of the rash.</p> <p align=""justify"">This drug is only effective if commenced within 72 hours of onset of rash.</p> <p align=""justify"">Aciclovir 800 mg is not PBS-subsidised for herpes simplex or chickenpox.</p> <p align=""justify"">No applications for repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5968_5968_R","null","STREAMLINED","5968","5968","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes zoster ophthalmicus</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Herpes zoster ophthalmicus</p> <p align=""justify"">This drug is only effective if commenced within 72 hours of onset of rash.</p> <p align=""justify"">Valaciclovir 500 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.</p> <p align=""justify"">No applications for repeats will be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5969_5969_R","null","AUTHORITY_REQUIRED","5969","5969","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 12 weeks.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 12 weeks.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p align=""justify"">Special Pricing Arrangements apply.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5970_5970_R","null","RESTRICTED","5970","5970","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5971_5971_R","Suppressive therapy","STREAMLINED","5971","5971","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Suppressive therapy</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Recurrent moderate to severe genital herpes</p><br/><p>Suppressive therapy</p> <p align=""justify"">Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.</p> <p align=""justify"">Famciclovir 250 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5973_5973_R","null","RESTRICTED","5973","5973","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Megaloblastic anaemias</p><br/><p>The condition must be a result of folic acid deficiency from the use of folic acid antagonists.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Megaloblastic anaemias</p><br/><p>The condition must be a result of folic acid deficiency from the use of folic acid antagonists.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5974_5974_R","Continuing treatment","AUTHORITY_REQUIRED","5974","5974","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must have responded to an initial course of PBS-subsidised treatment; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align=""justify"">Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must have responded to an initial course of PBS-subsidised treatment; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align=""justify"">Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.</p><p/> <p/><p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5975_5975_R","Prophylaxis","STREAMLINED","5975","5975","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Prophylaxis</p><br/><p>Patient must have undergone a renal transplant; AND</p> <p>Patient must be at risk of cytomegalovirus disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Prophylaxis</p><br/><p>Patient must have undergone a renal transplant; AND</p> <p>Patient must be at risk of cytomegalovirus disease.</p>","N","N","N","IMMEDIATE","ALL","N","2016-03-01","N","4708"
"5984_5984_R","null","RESTRICTED","5984","5984","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p><br/><p>The treatment must be for preventing low plasma arginine levels; or</p> <p>The treatment must be for preventing low citrulline levels.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p><br/><p>The treatment must be for preventing low plasma arginine levels; or</p> <p>The treatment must be for preventing low citrulline levels.</p> <p>Citrulline is not indicated for the treatment of arginase deficiency and other inborn errors of protein metabolism</p>","N","N","N","IMMEDIATE","ALL","N","2016-04-01","N","4708"
"5986_5986_R","null","RESTRICTED","5986","5986","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Propionic acidaemia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Propionic acidaemia</p>","N","N","N","IMMEDIATE","ALL","N","2016-04-01","N","4708"
"5995_5995_R","null","RESTRICTED","5995","5995","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p><br/><p>The condition must not be responding to other tetracyclines.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">There are concerns about the incidence of benign intracranial hypertension associated with this drug.</p> <p>Severe acne</p><br/><p>The condition must not be responding to other tetracyclines.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-04-01","N","4708"
"5997_5997_R","null","STREAMLINED","5997","5997","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute promyelocytic leukaemia</p><br/><p>The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute promyelocytic leukaemia</p><br/><p>The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript.</p>","N","N","N","IMMEDIATE","ALL","N","2016-04-01","N","4708"
"5999_5999_R","null","RESTRICTED","5999","5999","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Confirmed or suspected Plasmodium falciparum malaria</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Confirmed or suspected Plasmodium falciparum malaria</p> <p align=""justify"">This drug is not PBS-subsidised for prophylaxis of malaria.</p>","N","N","N","IMMEDIATE","ALL","N","2016-04-01","N","4708"
"6007_6007_R","null","RESTRICTED","6007","6007","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven glutaric aciduria type 1</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven glutaric aciduria type 1</p>","N","N","N","IMMEDIATE","ALL","N","2016-04-01","N","4708"
"6018_6018_R","Induction and consolidation treatment","STREAMLINED","6018","6018","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute promyelocytic leukaemia</p><br/><p>Induction and consolidation treatment</p><br/><p>The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute promyelocytic leukaemia</p><br/><p>Induction and consolidation treatment</p><br/><p>The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR-alpha fusion gene transcript.</p>","N","N","N","IMMEDIATE","ALL","N","2016-04-01","N","4708"
"6038_6038_R","null","RESTRICTED","6038","6038","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pyridoxine non-responsive homocystinuria</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pyridoxine non-responsive homocystinuria</p>","N","N","N","IMMEDIATE","ALL","N","2016-04-01","N","4708"
"6055_6055_R","null","RESTRICTED","6055","6055","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Methylmalonic acidaemia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Methylmalonic acidaemia</p>","N","N","N","IMMEDIATE","ALL","N","2016-04-01","N","4708"
"6056_6056_R","null","RESTRICTED","6056","6056","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Glioblastoma multiforme</p><br/><p>The condition must be suspected or confirmed at the time of initial surgery.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Glioblastoma multiforme</p><br/><p>The condition must be suspected or confirmed at the time of initial surgery.</p> <p align=""justify"">Carmustine is not PBS-subsidised for use in conjunction with PBS-subsidised temozolomide.</p>","N","N","N","IMMEDIATE","ALL","N","2016-04-01","N","4708"
"6080_6080_R","null","RESTRICTED","6080","6080","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corneal grafts</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corneal grafts</p>","N","N","N","IMMEDIATE","ALL","N","2016-05-01","N","4708"
"6084_6084_R","null","STREAMLINED","6084","6084","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea or gastric stasis</p><br/><p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea or gastric stasis</p><br/><p>Patient must be receiving palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2016-05-01","N","4708"
"6087_6087_R","null","RESTRICTED","6087","6087","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uveitis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uveitis</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-05-01","N","4708"
"6101_6101_R","null","RESTRICTED","6101","6101","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uveitis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Uveitis</p>","N","N","N","IMMEDIATE","ALL","N","2016-05-01","N","4708"
"6106_6106_R","null","STREAMLINED","6106","6106","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic breast cancer</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic breast cancer</p>","N","N","N","IMMEDIATE","ALL","N","2016-05-01","N","4708"
"6118_6118_R","null","RESTRICTED","6118","6118","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eradication of Helicobacter pylori</p><br/><p>The condition must be associated with peptic ulcer disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eradication of Helicobacter pylori</p><br/><p>The condition must be associated with peptic ulcer disease.</p> <p align=""justify"">Pharmaceutical benefits that have the form pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate) and pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate) are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2016-05-01","N","4708"
"6119_6119_R","null","STREAMLINED","6119","6119","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HER2 positive breast cancer</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HER2 positive breast cancer</p>","N","N","N","IMMEDIATE","ALL","N","2016-05-01","N","4708"
"6133_6133_R","null","STREAMLINED","6133","6133","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteomyelitis</p><br/><p>The condition must be methicillin-resistant staphylococcal aureus (MRSA); AND</p> <p>The treatment must be used in combination with other anti-staphylococcal antibiotics.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteomyelitis</p><br/><p>The condition must be methicillin-resistant staphylococcal aureus (MRSA); AND</p> <p>The treatment must be used in combination with other anti-staphylococcal antibiotics.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6138_6138_R","null","STREAMLINED","6138","6138","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe intestinal malabsorption including short bowel syndrome</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe intestinal malabsorption including short bowel syndrome</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6139_6139_R","null","RESTRICTED","6139","6139","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6141_6141_R","null","RESTRICTED","6141","6141","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Peroxisomal biogenesis disorders</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Peroxisomal biogenesis disorders</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6149_6149_R","null","RESTRICTED","6149","6149","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must be receiving palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6150_6150_R","null","RESTRICTED","6150","6150","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must be undergoing palliative care; AND</p> <p>Patient must be unable to take a solid dose form of a non-steroidal anti-inflammatory agent.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must be undergoing palliative care; AND</p> <p>Patient must be unable to take a solid dose form of a non-steroidal anti-inflammatory agent.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6152_6152_R","null","RESTRICTED","6152","6152","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a highly restrictive therapeutic diet</p><br/><p>Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND</p> <p>Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations; AND</p> <p>Patient must be an infant or a child.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a highly restrictive therapeutic diet</p><br/><p>Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND</p> <p>Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations; AND</p> <p>Patient must be an infant or a child.</p> <p align=""justify"">Paediatric Seravit must only be used under strict supervision of a dietitian and a paediatrician.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6157_6157_R","null","STREAMLINED","6157","6157","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic liver failure with fat malabsorption</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic liver failure with fat malabsorption</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6158_6158_R","null","STREAMLINED","6158","6158","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Enterokinase deficiency</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Enterokinase deficiency</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6158_N","null","null","null","null","null","<p>Authorities for increased maximum quantities and/or repeats for the oral forms of diazepam will be granted only for </p><blockquote style=""MARGIN-RIGHT: 0px""><p>(i) the treatment of disabling spasticity; or</p></blockquote><blockquote style=""MARGIN-RIGHT: 0px""><p>(ii) malignant neoplasia (late stage); or</p></blockquote><blockquote style=""MARGIN-RIGHT: 0px""><p>(iii) use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past six months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal; or</p></blockquote><blockquote style=""MARGIN-RIGHT: 0px""><p>(iv) use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past six months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal.</p></blockquote><p> Up to six months&apos; treatment (i.e. one month&apos;s treatment with five repeats) may be requested.</p>","Y","N","N","null","null","N","1991-08-01","N","4708"
"6159_6159_R","null","RESTRICTED","6159","6159","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a highly restrictive therapeutic diet</p><br/><p>Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND</p> <p>Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations; AND</p> <p>Patient must be aged 3 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a highly restrictive therapeutic diet</p><br/><p>Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND</p> <p>Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">FruitiVits must only be used under strict supervision of a dietitian and a paediatrician.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6160_6160_R","null","STREAMLINED","6160","6160","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p><br/><p>The condition must be one in which tetracycline therapy is inappropriate.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe acne</p><br/><p>The condition must be one in which tetracycline therapy is inappropriate.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6163_6163_R","null","RESTRICTED","6163","6163","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prostatitis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prostatitis</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6166_6166_R","null","STREAMLINED","6166","6166","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven fat malabsorption</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven fat malabsorption</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6167_6167_R","null","RESTRICTED","6167","6167","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Analgesia or fever</p><br/><p>Patient must be receiving palliative care; AND</p> <p>Patient must be intolerant to alternative therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Analgesia or fever</p><br/><p>Patient must be receiving palliative care; AND</p> <p>Patient must be intolerant to alternative therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6171_6171_R","null","STREAMLINED","6171","6171","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6172_6172_R","null","STREAMLINED","6172","6172","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe dry eye syndrome</p><br/><p>Patient must be sensitive to preservatives in multi-dose eye drops.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe dry eye syndrome</p><br/><p>Patient must be sensitive to preservatives in multi-dose eye drops.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6175_6175_R","null","AUTHORITY_REQUIRED","6175","6175","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Insomnia</p><br/><p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Insomnia</p><br/><p>Patient must be receiving palliative care.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6176_6176_R","null","AUTHORITY_REQUIRED","6176","6176","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anxiety</p><br/><p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anxiety</p><br/><p>Patient must be receiving palliative care.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6180_6180_R","null","STREAMLINED","6180","6180","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Opioid-induced constipation</p><br/><p>The treatment must be in combination with oral laxatives; AND</p> <p>Patient must be receiving palliative care; AND</p> <p>Patient must have failed to respond to laxatives.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Opioid-induced constipation</p><br/><p>The treatment must be in combination with oral laxatives; AND</p> <p>Patient must be receiving palliative care; AND</p> <p>Patient must have failed to respond to laxatives.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6188_6188_R","null","STREAMLINED","6188","6188","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteomyelitis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteomyelitis</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6190_6190_R","null","STREAMLINED","6190","6190","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic renal failure</p><br/><p>Patient must be an infant or a young child; AND</p> <p>Patient must require treatment with a low protein and a low phosphorus diet; or</p> <p>Patient must require treatment with a low protein, low phosphorus and low potassium diet.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic renal failure</p><br/><p>Patient must be an infant or a young child; AND</p> <p>Patient must require treatment with a low protein and a low phosphorus diet; or</p> <p>Patient must require treatment with a low protein, low phosphorus and low potassium diet.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6194_6194_R","null","STREAMLINED","6194","6194","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biliary atresia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Biliary atresia</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6195_6195_R","null","STREAMLINED","6195","6195","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6196_6196_R","null","RESTRICTED","6196","6196","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must be receiving palliative care.</p> <p align=""justify"">Naproxen sodium 550 mg is approximately equivalent to 500 mg of naproxen acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6197_6197_R","null","STREAMLINED","6197","6197","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Painful mouth</p><br/><p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Painful mouth</p><br/><p>Patient must be receiving palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6205_6205_R","null","STREAMLINED","6205","6205","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylous ascites</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chylous ascites</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6207_6207_R","null","STREAMLINED","6207","6207","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For use in patients receiving palliative care</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For use in patients receiving palliative care</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6208_6208_R","null","RESTRICTED","6208","6208","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia</p><br/><p>Patient must be under the age of 4 years.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia</p><br/><p>Patient must be under the age of 4 years.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2016-06-01","N","4708"
"6209_6209_R","null","RESTRICTED","6209","6209","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Local intra-articular or peri-articular infiltration</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Local intra-articular or peri-articular infiltration</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6213_6213_R","null","RESTRICTED","6213","6213","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Menorrhagia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Menorrhagia</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6214_6214_R","null","RESTRICTED","6214","6214","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies (including osteoarthritis)</p><br/><p>The condition must have an inflammatory component.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies (including osteoarthritis)</p><br/><p>The condition must have an inflammatory component.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6217_6217_R","null","AUTHORITY_REQUIRED","6217","6217","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Malignant neoplasia (late stage)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Malignant neoplasia (late stage)</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6221_6221_R","null","RESTRICTED","6221","6221","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anovulatory infertility</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anovulatory infertility</p> <p align=""justify"">Care must be taken to comply with the provisions of State/Territory law when prescribing this drug.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6222_6222_R","null","STREAMLINED","6222","6222","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic granulomatous disease</p><br/><p>Patient must have frequent and severe infections despite adequate prophylaxis with antimicrobial agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic granulomatous disease</p><br/><p>Patient must have frequent and severe infections despite adequate prophylaxis with antimicrobial agents.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6224_6224_R","null","RESTRICTED","6224","6224","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Lymphoma</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Lymphoma</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6225_6225_R","null","RESTRICTED","6225","6225","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Analgesia or fever</p><br/><p>Patient must be receiving palliative care; AND</p> <p>Patient must be intolerant to alternative therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Analgesia or fever</p><br/><p>Patient must be receiving palliative care; AND</p> <p>Patient must be intolerant to alternative therapy.</p> <p align=""justify"">Pharmaceutical benefits that have the form paracetamol 665 mg modified release tablet, 96 and pharmaceutical benefits that have the form paracetamol 665 mg modified release tablet, 192 are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6229_6229_R","null","RESTRICTED","6229","6229","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dysmenorrhoea</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dysmenorrhoea</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6230_6230_R","null","AUTHORITY_REQUIRED","6230","6230","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anxiety</p><br/><p>Patient must be receiving this drug for the management of anxiety; AND</p> <p>Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; AND</p> <p>Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anxiety</p><br/><p>Patient must be receiving this drug for the management of anxiety; AND</p> <p>Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; AND</p> <p>Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6234_6234_R","null","STREAMLINED","6234","6234","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Kaposi sarcoma</p><br/><p>The condition must be AIDS-related; AND</p> <p>Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND</p> <p>The condition must include extensive mucocutaneous involvement.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Kaposi sarcoma</p><br/><p>The condition must be AIDS-related; AND</p> <p>Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND</p> <p>The condition must include extensive mucocutaneous involvement.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6236_6236_R","null","RESTRICTED","6236","6236","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Depression</p><br/><p>The treatment must be for when all other anti-depressant therapy has failed; or</p> <p>The treatment must be for when all other anti-depressant therapy is inappropriate.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">This drug is an irreversible monoamine oxidase inhibitor.</p> <p>Depression</p><br/><p>The treatment must be for when all other anti-depressant therapy has failed; or</p> <p>The treatment must be for when all other anti-depressant therapy is inappropriate.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6237_6237_R","null","RESTRICTED","6237","6237","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Keloid</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Keloid</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6240_6240_R","null","RESTRICTED","6240","6240","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients undergoing in-vitro fertilisation</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients undergoing in-vitro fertilisation</p> <p align=""justify"">Care must be taken to comply with the provisions of State/Territory law when prescribing this drug.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6241_6241_R","null","RESTRICTED","6241","6241","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Detrusor overactivity</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Detrusor overactivity</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6243_6243_R","null","RESTRICTED","6243","6243","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Detrusor overactivity</p><br/><p>Patient must be unable to tolerate oral oxybutynin; or</p> <p>Patient must be unable to swallow oral oxybutynin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Detrusor overactivity</p><br/><p>Patient must be unable to tolerate oral oxybutynin; or</p> <p>Patient must be unable to swallow oral oxybutynin.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6244_6244_R","null","RESTRICTED","6244","6244","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6247_6247_R","null","RESTRICTED","6247","6247","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute myelogenous leukaemia (AML)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute myelogenous leukaemia (AML)</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6252_6252_R","null","RESTRICTED","6252","6252","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For use in a hospital</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For use in a hospital</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6256_6256_R","null","RESTRICTED","6256","6256","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone pain</p><br/><p>The condition must be due to malignant disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone pain</p><br/><p>The condition must be due to malignant disease.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6257_6257_R","null","RESTRICTED","6257","6257","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anovulatory infertility</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anovulatory infertility</p> <p align=""justify"">Except in cases of hypopituitarism or primary amenorrhoea, the patient should have been adequately treated with clomifene citrate and/or gonadorelin and failed to have conceived.</p> <p align=""justify"">Women who have had apparent ovulation induced by other agents and have failed to conceive should have laparoscopic evidence that there is no other impediment to conception. </p> <p>Oligomenorrhoea should have been present for at least twelve months or amenorrhoea for at least six months prior to treatment.</p> <p align=""justify"">Patients with hyperprolactinaemia should have had appropriate surgical or medical treatment prior to treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6262_6262_R","null","AUTHORITY_REQUIRED","6262","6262","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anxiety</p><br/><p>Patient must be receiving this drug for the management of anxiety; AND</p> <p>Patient must be receiving long-term nursing care; AND</p> <p>Patient must be one in respect of whom a Carer Allowance is payable as a disabled adult; AND</p> <p>Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anxiety</p><br/><p>Patient must be receiving this drug for the management of anxiety; AND</p> <p>Patient must be receiving long-term nursing care; AND</p> <p>Patient must be one in respect of whom a Carer Allowance is payable as a disabled adult; AND</p> <p>Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6265_6265_R","null","STREAMLINED","6265","6265","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hairy cell leukaemia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hairy cell leukaemia</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6266_6266_R","null","RESTRICTED","6266","6266","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients requiring administration of fluorouracil by intravenous infusion</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients requiring administration of fluorouracil by intravenous infusion</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6273_6273_R","null","RESTRICTED","6273","6273","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Local intra-articular or peri-articular infiltration</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Local intra-articular or peri-articular infiltration</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6274_6274_R","null","STREAMLINED","6274","6274","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Kaposi sarcoma</p><br/><p>The condition must be AIDS-related; AND</p> <p>Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND</p> <p>The condition must include extensive visceral involvement.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Kaposi sarcoma</p><br/><p>The condition must be AIDS-related; AND</p> <p>Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND</p> <p>The condition must include extensive visceral involvement.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6275_6275_R","null","RESTRICTED","6275","6275","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Germ cell neoplasms</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Germ cell neoplasms</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6276_6276_R","null","RESTRICTED","6276","6276","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients receiving treatment with a high dose regimen</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients receiving treatment with a high dose regimen</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6277_6277_R","null","RESTRICTED","6277","6277","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Obsessive-compulsive disorder</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Obsessive-compulsive disorder</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6280_6280_R","null","RESTRICTED","6280","6280","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Persistent pain</p><br/><p>The condition must be associated with osteoarthritis; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Persistent pain</p><br/><p>The condition must be associated with osteoarthritis; AND</p> <p>Patient must identify as Aboriginal or Torres Strait Islander.</p> <p align=""justify"">Pharmaceutical benefits that have the form paracetamol 665 mg modified release tablet, 96 and pharmaceutical benefits that have the form paracetamol 665 mg modified release tablet, 192 are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6282_6282_R","null","RESTRICTED","6282","6282","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies (including osteoarthritis)</p><br/><p>The condition must have an inflammatory component.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies (including osteoarthritis)</p><br/><p>The condition must have an inflammatory component.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6283_6283_R","null","RESTRICTED","6283","6283","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone pain</p><br/><p>The condition must be due to malignant disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone pain</p><br/><p>The condition must be due to malignant disease.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6289_6289_R","null","RESTRICTED","6289","6289","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Panic disorder</p><br/><p>The treatment must be for use when other treatments have failed; or</p> <p>The treatment must be for use when other treatments are inappropriate.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Panic disorder</p><br/><p>The treatment must be for use when other treatments have failed; or</p> <p>The treatment must be for use when other treatments are inappropriate.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6291_6291_R","null","RESTRICTED","6291","6291","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Lichen planus hypertrophic</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Lichen planus hypertrophic</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6294_6294_R","null","STREAMLINED","6294","6294","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaemia associated with intrinsic renal disease</p><br/><p>Patient must require transfusion; AND</p> <p>Patient must have a haemoglobin level of less than 100 g per L; AND</p> <p>Patient must have intrinsic renal disease, as assessed by a nephrologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaemia associated with intrinsic renal disease</p><br/><p>Patient must require transfusion; AND</p> <p>Patient must have a haemoglobin level of less than 100 g per L; AND</p> <p>Patient must have intrinsic renal disease, as assessed by a nephrologist.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6297_6297_R","null","RESTRICTED","6297","6297","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients requiring administration of fluorouracil by intravenous injection</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Patients requiring administration of fluorouracil by intravenous injection</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6301_6301_R","null","RESTRICTED","6301","6301","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage 2 and above pressure injury</p><br/><p>The treatment must be for special medical purposes to support healing of pressure injuries.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage 2 and above pressure injury</p><br/><p>The treatment must be for special medical purposes to support healing of pressure injuries.</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6303_6303_R","null","RESTRICTED","6303","6303","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-responsive dermatoses</p>","N","N","N","IMMEDIATE","ALL","N","2016-07-01","N","4708"
"6306_6306_R","null","STREAMLINED","6306","6306","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-08-01","N","4708"
"6307_6307_R","null","STREAMLINED","6307","6307","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p> <p align=""justify"">Fosamax Plus provides a supplemental intake of vitamin D. The amount of colecalciferol present in Fosamax Plus is not sufficient to use as the sole treatment for correction of vitamin D deficiency.</p>","N","N","N","IMMEDIATE","ALL","N","2016-08-01","N","4708"
"6310_6310_R","null","RESTRICTED","6310","6310","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-08-01","N","4708"
"6314_6314_R","null","STREAMLINED","6314","6314","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established post-menopausal osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established post-menopausal osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-08-01","N","4708"
"6315_6315_R","null","STREAMLINED","6315","6315","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p> <p align=""justify"">Fosamax Plus provides a supplemental intake of vitamin D. The amount of colecalciferol present in Fosamax Plus is not sufficient to use as the sole treatment for correction of vitamin D deficiency.</p>","N","N","N","IMMEDIATE","ALL","N","2016-08-01","N","4708"
"6319_6319_R","null","STREAMLINED","6319","6319","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-08-01","N","4708"
"6320_6320_R","null","STREAMLINED","6320","6320","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p> <p align=""justify"">Fosamax Plus provides a supplemental intake of vitamin D. The amount of colecalciferol present in Fosamax Plus is not sufficient to use as the sole treatment for correction of vitamin D deficiency.</p>","N","N","N","IMMEDIATE","ALL","N","2016-08-01","N","4708"
"6321_6321_R","null","RESTRICTED","6321","6321","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infertility</p><br/><p>The condition must be due to hypogonadotrophic hypogonadism; AND</p> <p>The treatment must be following failure of 6 months'' treatment with human chorionic gonadotrophin to achieve adequate spermatogenesis; AND</p> <p>The treatment must be administered with human chorionic gonadotrophin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infertility</p><br/><p>The condition must be due to hypogonadotrophic hypogonadism; AND</p> <p>The treatment must be following failure of 6 months'' treatment with human chorionic gonadotrophin to achieve adequate spermatogenesis; AND</p> <p>The treatment must be administered with human chorionic gonadotrophin.</p> <p align=""justify"">Except in cases of hypopituitarism or primary amenorrhoea, the patient should have been adequately treated with clomifene citrate and/or gonadorelin and failed to have conceived.</p> <p align=""justify"">Patients with hyperprolactinaemia should have had appropriate surgical or medical treatment prior to treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2016-08-01","N","4708"
"6323_6323_R","null","RESTRICTED","6323","6323","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Corticosteroid-induced osteoporosis</p><br/><p>Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-08-01","N","4708"
"6324_6324_R","null","AUTHORITY_REQUIRED","6324","6324","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>Patient must not have an established pituitary or testicular disorder; AND</p> <p>The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs; AND</p> <p>Patient must be aged 40 years or older; AND</p> <p>Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">Androgen deficiency is defined as:</p><p align=""justify"">(i) testosterone level of less than 6 nmol per litre; OR</p><p align=""justify"">(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).</p><p align=""justify"">Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.</p> <p>The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>Patient must not have an established pituitary or testicular disorder; AND</p> <p>The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs; AND</p> <p>Patient must be aged 40 years or older; AND</p> <p>Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">Androgen deficiency is defined as:</p><p align=""justify"">(i) testosterone level of less than 6 nmol per litre; OR</p><p align=""justify"">(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).</p><p align=""justify"">Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.</p> <p>The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2016-08-01","N","4708"
"6325_6325_R","null","STREAMLINED","6325","6325","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-08-01","N","4708"
"6327_6327_R","null","RESTRICTED","6327","6327","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-08-01","N","4708"
"6328_6328_R","null","AUTHORITY_REQUIRED","6328","6328","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Drug interactions expected to occur with all of the base-priced drugs</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Drug interactions expected to occur with all of the base-priced drugs</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6329_6329_R","null","AUTHORITY_REQUIRED","6329","6329","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6331_6331_R","null","RESTRICTED","6331","6331","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6332_6332_R","null","AUTHORITY_REQUIRED","6332","6332","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Drug interactions occurring with all of the base-priced drugs</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Drug interactions occurring with all of the base-priced drugs</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6340_6340_R","null","STREAMLINED","6340","6340","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic asthma</p><br/><p>Patient must require long-term steroid therapy; AND</p> <p>Patient must not be able to use other forms of inhaled steroid therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic asthma</p><br/><p>Patient must require long-term steroid therapy; AND</p> <p>Patient must not be able to use other forms of inhaled steroid therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6342_6342_R","null","RESTRICTED","6342","6342","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondarily infected traumatic skin lesions</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Secondarily infected traumatic skin lesions</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6343_6343_R","null","AUTHORITY_REQUIRED","6343","6343","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diarrhoea</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diarrhoea</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6348_6348_R","null","RESTRICTED","6348","6348","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must be unable to achieve co-ordinated use of other metered dose inhalers containing this drug.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must be unable to achieve co-ordinated use of other metered dose inhalers containing this drug.</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6350_6350_R","null","STREAMLINED","6350","6350","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycobacterium avium complex infection</p><br/><p>Patient must be human immunodeficiency virus (HIV) positive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycobacterium avium complex infection</p><br/><p>Patient must be human immunodeficiency virus (HIV) positive.</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6351_6351_R","null","AUTHORITY_REQUIRED","6351","6351","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adverse effects occurring with all of the base-priced drugs</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Adverse effects occurring with all of the base-priced drugs</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6355_6355_R","null","RESTRICTED","6355","6355","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must experience frequent episodes of the condition; AND</p> <p>Patient must be currently receiving treatment with oral corticosteroids; or</p> <p>Patient must be currently receiving treatment with optimal doses of inhaled corticosteroids.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must experience frequent episodes of the condition; AND</p> <p>Patient must be currently receiving treatment with oral corticosteroids; or</p> <p>Patient must be currently receiving treatment with optimal doses of inhaled corticosteroids.</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6356_6356_R","null","STREAMLINED","6356","6356","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycobacterium avium complex infection</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be human immunodeficiency virus (HIV) positive; AND</p> <p>Patient must have CD4 cell counts of less than 75 per cubic millimetre.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycobacterium avium complex infection</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be human immunodeficiency virus (HIV) positive; AND</p> <p>Patient must have CD4 cell counts of less than 75 per cubic millimetre.</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6359_6359_R","null","RESTRICTED","6359","6359","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic spasticity</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic spasticity</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6364_6364_R","null","STREAMLINED","6364","6364","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diarrhoea</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Diarrhoea</p><br/><p>Patient must identify as Aboriginal or Torres Strait Islander.</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6367_6367_R","null","RESTRICTED","6367","6367","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchospasm</p><br/><p>Patient must be unable to achieve co-ordinated use of other metered dose inhalers containing this drug.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchospasm</p><br/><p>Patient must be unable to achieve co-ordinated use of other metered dose inhalers containing this drug.</p>","N","N","N","IMMEDIATE","ALL","N","2016-09-01","N","4708"
"6368_6368_R","null","RESTRICTED","6368","6368","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies (including osteoarthritis)</p><br/><p>The condition must have an inflammatory component.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies (including osteoarthritis)</p><br/><p>The condition must have an inflammatory component.</p> <p align=""justify"">Naproxen sodium 550 mg is approximately equivalent to 500 mg of naproxen acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6369_6369_R","null","STREAMLINED","6369","6369","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vasoactive intestinal peptide secreting tumour (VIPoma)</p><br/><p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months'' therapy.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vasoactive intestinal peptide secreting tumour (VIPoma)</p><br/><p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months'' therapy.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6370_6370_R","null","STREAMLINED","6370","6370","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p> <p>Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p> <p>Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.</p> <p>Aprepitant is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"6375_6375_R","null","AUTHORITY_REQUIRED","6375","6375","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Onychomycosis</p><br/><p>The condition must be due to dermatophyte infection proven by microscopy and confirmed by an Approved Pathology Provider; or</p> <p>The condition must be due to dermatophyte infection proven by culture and confirmed by an Approved Pathology Provider.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Onychomycosis</p><br/><p>The condition must be due to dermatophyte infection proven by microscopy and confirmed by an Approved Pathology Provider; or</p> <p>The condition must be due to dermatophyte infection proven by culture and confirmed by an Approved Pathology Provider.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6377_6377_R","null","STREAMLINED","6377","6377","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human immunodeficiency virus (HIV) infection</p><br/><p>The treatment must be in addition to optimised background therapy; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>The treatment must not be in combination with ritonavir; AND</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human immunodeficiency virus (HIV) infection</p><br/><p>The treatment must be in addition to optimised background therapy; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>The treatment must not be in combination with ritonavir; AND</p> <p>Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen.</p> <p>Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.</p> <p align=""justify"">The cobicistat component of the darunavir + cobicistat combination product provides the necessary pharmacokinetic enhancement of darunavir to achieve therapeutic levels of darunavir.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6383_6383_R","null","STREAMLINED","6383","6383","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p> <p>Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p> <p>Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.</p> <p>Aprepitant is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"6386_6386_R","null","RESTRICTED","6386","6386","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Onychomycosis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Onychomycosis</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6387_6387_R","null","RESTRICTED","6387","6387","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone pain</p><br/><p>The condition must be due to malignant disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone pain</p><br/><p>The condition must be due to malignant disease.</p> <p align=""justify"">Naproxen sodium 550 mg is approximately equivalent to 500 mg of naproxen acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6390_6390_R","null","STREAMLINED","6390","6390","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months'' therapy.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months'' therapy.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6394_6394_R","null","STREAMLINED","6394","6394","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Disorders of erythropoiesis</p><br/><p>The condition must be associated with treatment-related chronic iron overload.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Disorders of erythropoiesis</p><br/><p>The condition must be associated with treatment-related chronic iron overload.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6403_6403_R","null","STREAMLINED","6403","6403","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron overload</p><br/><p>Patient must have thalassaemia major; AND</p> <p>Patient must be one in whom desferrioxamine therapy has proven ineffective.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron overload</p><br/><p>Patient must have thalassaemia major; AND</p> <p>Patient must be one in whom desferrioxamine therapy has proven ineffective.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6404_6404_R","null","AUTHORITY_REQUIRED","6404","6404","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dermatophyte infection</p><br/><p>Patient must have failed to respond to topical treatment; AND</p> <p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dermatophyte infection</p><br/><p>Patient must have failed to respond to topical treatment; AND</p> <p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6412_6412_R","null","STREAMLINED","6412","6412","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fungal or yeast infection</p><br/><p>The condition must be fungal; or</p> <p>The condition must be due to yeast; AND</p> <p>Patient must be 18 years of age or less.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fungal or yeast infection</p><br/><p>The condition must be fungal; or</p> <p>The condition must be due to yeast; AND</p> <p>Patient must be 18 years of age or less.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6413_6413_R","Initial treatment","STREAMLINED","6413","6413","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human immunodeficiency virus (HIV) infection</p><br/><p>Initial treatment</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>The treatment must not be in combination with ritonavir.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human immunodeficiency virus (HIV) infection</p><br/><p>Initial treatment</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>The treatment must not be in combination with ritonavir.</p> <p align=""justify"">The cobicistat component of the darunavir + cobicistat combination product provides the necessary pharmacokinetic enhancement of darunavir to achieve therapeutic levels of darunavir.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6428_6428_R","Continuing treatment","STREAMLINED","6428","6428","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human immunodeficiency virus (HIV) infection</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>The treatment must not be in combination with ritonavir.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Human immunodeficiency virus (HIV) infection</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must be in combination with other antiretroviral agents; AND</p> <p>The treatment must not be in combination with ritonavir.</p> <p align=""justify"">The cobicistat component of the darunavir + cobicistat combination product provides the necessary pharmacokinetic enhancement of darunavir to achieve therapeutic levels of darunavir.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6434_6434_R","null","STREAMLINED","6434","6434","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fungal or yeast infection</p><br/><p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Fungal or yeast infection</p><br/><p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6444_6444_R","null","STREAMLINED","6444","6444","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND</p> <p>Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p> <p>Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND</p> <p>Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p> <p>Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.</p> <p>Aprepitant is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"6448_6448_R","null","STREAMLINED","6448","6448","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron overload</p><br/><p>Patient must have thalassaemia major; AND</p> <p>Patient must be unable to take desferrioxamine therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron overload</p><br/><p>Patient must have thalassaemia major; AND</p> <p>Patient must be unable to take desferrioxamine therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6453_6453_R","null","AUTHORITY_REQUIRED","6453","6453","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dermatophyte infection</p><br/><p>Patient must have failed to respond to topical treatment; AND</p> <p>Patient must have failed to respond to griseofulvin; AND</p> <p>Patient must be 18 years of age or less.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dermatophyte infection</p><br/><p>Patient must have failed to respond to topical treatment; AND</p> <p>Patient must have failed to respond to griseofulvin; AND</p> <p>Patient must be 18 years of age or less.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6463_6463_R","null","RESTRICTED","6463","6463","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies (including osteoarthritis)</p><br/><p>The condition must have an inflammatory component.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic arthropathies (including osteoarthritis)</p><br/><p>The condition must have an inflammatory component.</p> <p align=""justify"">Naproxen sodium 550 mg is approximately equivalent to 500 mg of naproxen acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6464_6464_R","null","STREAMLINED","6464","6464","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND</p> <p>Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p> <p>Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND</p> <p>Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.</p> <p align=""justify"">No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.</p> <p>Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.</p> <p>Aprepitant is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"6471_6471_R","null","RESTRICTED","6471","6471","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone pain</p><br/><p>The condition must be due to malignant disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone pain</p><br/><p>The condition must be due to malignant disease.</p> <p align=""justify"">Naproxen sodium 550 mg is approximately equivalent to 500 mg of naproxen acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6479_6479_R","null","RESTRICTED","6479","6479","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tinea pedis</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tinea pedis</p>","N","N","N","IMMEDIATE","ALL","N","2016-10-01","N","4708"
"6517_6517_R","Subsequent treatment, for up to 6 months","RESTRICTED","6517","6517","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p><br/><p>Subsequent treatment, for up to 6 months</p><br/><p>The condition must be visually proven; AND</p> <p>The treatment must not be within 2 years of the end of the previous course of treatment with this drug; AND</p> <p>Patient must have had a recent bone density assessment.</p> <p align=""justify"">The date of the bone density assessment must be recorded in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p><br/><p>Subsequent treatment, for up to 6 months</p><br/><p>The condition must be visually proven; AND</p> <p>The treatment must not be within 2 years of the end of the previous course of treatment with this drug; AND</p> <p>Patient must have had a recent bone density assessment.</p> <p align=""justify"">The date of the bone density assessment must be recorded in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2016-11-01","N","4708"
"6523_N","null","null","null","null","null","<p>For immunisation of adults and children aged greater than or equal to 8 years.</p>","Y","N","N","null","null","N","1991-08-01","N","4708"
"6524_6524_R","null","STREAMLINED","6524","6524","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Established osteoporosis</p><br/><p>Patient must have fracture due to minimal trauma; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p/><p>The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient&apos;s medical records when treatment is initiated.</p><p/> <p>A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-11-01","N","4708"
"6548_6548_R","null","STREAMLINED","6548","6548","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Osteoporosis</p><br/><p>Patient must be aged 70 years or older; AND</p> <p>Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND</p> <p>Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.</p> <p align=""justify"">The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient&apos;s medical records when treatment is initiated.</p> <p align=""justify"">Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.</p>","N","N","N","IMMEDIATE","ALL","N","2016-11-01","N","4708"
"6552_6552_R","Initial treatment, for up to 6 months","RESTRICTED","6552","6552","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p><br/><p>Initial treatment, for up to 6 months</p><br/><p>The condition must be visually proven.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Endometriosis</p><br/><p>Initial treatment, for up to 6 months</p><br/><p>The condition must be visually proven.</p>","N","N","N","IMMEDIATE","ALL","N","2016-11-01","N","4708"
"6621_6621_R","null","STREAMLINED","6621","6621","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic neutropenia</p><br/><p>Patient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; or</p> <p>Patient must have neutrophil dysfunction; AND</p> <p>Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; or</p> <p>Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic neutropenia</p><br/><p>Patient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; or</p> <p>Patient must have neutrophil dysfunction; AND</p> <p>Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; or</p> <p>Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6628_6628_R","null","STREAMLINED","6628","6628","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of transplant rejection</p><br/><p>The treatment must be used by organ or tissue transplant recipients.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of transplant rejection</p><br/><p>The treatment must be used by organ or tissue transplant recipients.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6631_6631_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","6631","6631","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nephrotic syndrome</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must have failed prior treatment with steroids and cytostatic drugs; or</p> <p>Patient must be intolerant to treatment with steroids and cytostatic drugs; or</p> <p>The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND</p> <p>Patient must not have renal impairment; AND</p> <p>Must be treated by a nephrologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Nephrotic syndrome</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must have failed prior treatment with steroids and cytostatic drugs; or</p> <p>Patient must be intolerant to treatment with steroids and cytostatic drugs; or</p> <p>The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND</p> <p>Patient must not have renal impairment; AND</p> <p>Must be treated by a nephrologist.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6636_6636_R","null","RESTRICTED","6636","6636","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Panic disorder</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Panic disorder</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6638_6638_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","6638","6638","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); or</p> <p>The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate); AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Severe active rheumatoid arthritis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); or</p> <p>The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate); AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6640_6640_R","null","STREAMLINED","6640","6640","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic cyclical neutropenia</p><br/><p>Patient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles; AND</p> <p>Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; or</p> <p>Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic cyclical neutropenia</p><br/><p>Patient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles; AND</p> <p>Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; or</p> <p>Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6643_6643_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","6643","6643","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of transplant rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must have had an organ or tissue transplantation; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of transplant rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must have had an organ or tissue transplantation; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6647_6647_R","null","STREAMLINED","6647","6647","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Staphylococcus aureus infection</p><br/><p>Patient must have nasal colonisation with the bacteria; AND</p> <p>Patient must be an Aboriginal or a Torres Strait Islander person.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Staphylococcus aureus infection</p><br/><p>Patient must have nasal colonisation with the bacteria; AND</p> <p>Patient must be an Aboriginal or a Torres Strait Islander person.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6653_6653_R","null","STREAMLINED","6653","6653","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mobilisation of peripheral blood progenitor cells</p><br/><p>The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mobilisation of peripheral blood progenitor cells</p><br/><p>The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6654_6654_R","null","STREAMLINED","6654","6654","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mobilisation of peripheral blood progenitor cells</p><br/><p>The treatment must be in a normal volunteer for use in allogeneic transplantation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mobilisation of peripheral blood progenitor cells</p><br/><p>The treatment must be in a normal volunteer for use in allogeneic transplantation.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6655_6655_R","null","STREAMLINED","6655","6655","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisting autologous peripheral blood progenitor cell transplantation</p><br/><p>The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisting autologous peripheral blood progenitor cell transplantation</p><br/><p>The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6658_6658_R","null","RESTRICTED","6658","6658","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency; or</p> <p>Patient must be an infant or young child with glucose-galactose intolerance and multiple monosaccharide intolerance.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency; or</p> <p>Patient must be an infant or young child with glucose-galactose intolerance and multiple monosaccharide intolerance.</p>","N","N","N","IMMEDIATE","ALL","N","2017-02-01","N","4708"
"6660_6660_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","6660","6660","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe atopic dermatitis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>The condition must be ineffective to other systemic therapies; or</p> <p>The condition must be inappropriate for other systemic therapies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Severe atopic dermatitis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>The condition must be ineffective to other systemic therapies; or</p> <p>The condition must be inappropriate for other systemic therapies.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6666_6666_R","First-line prevention","STREAMLINED","6666","6666","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>First-line prevention</p><br/><p>Patient must be aged 2 to 5 years inclusive; AND</p> <p>The condition must be frequent intermittent; or</p> <p>The condition must be mild persistent; AND</p> <p>The treatment must be the single preventer agent; AND</p> <p>The treatment must be an alternative to sodium cromoglycate; or</p> <p>The treatment must be an alternative to nedocromil sodium.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>First-line prevention</p><br/><p>Patient must be aged 2 to 5 years inclusive; AND</p> <p>The condition must be frequent intermittent; or</p> <p>The condition must be mild persistent; AND</p> <p>The treatment must be the single preventer agent; AND</p> <p>The treatment must be an alternative to sodium cromoglycate; or</p> <p>The treatment must be an alternative to nedocromil sodium.</p> <p>This drug is not PBS-subsidised for use in a child aged 2 to 5 years with moderate to severe asthma. It is not intended as an alternative for a child aged 2 to 5 years who requires a corticosteroid as a preventer medication.</p> <p align=""justify"">This drug is not subsidised in a child aged 2 to 5 years for use in combination with other preventer medications. PBS subsidy for this drug will therefore cease for a child aged 2 to 5 years who requires a preventer medication in addition to this drug.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6674_6674_R","First-line prevention","STREAMLINED","6674","6674","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>First-line prevention</p><br/><p>The condition must be frequent intermittent; or</p> <p>The condition must be mild persistent; AND</p> <p>The treatment must be the single preventer agent; AND</p> <p>The treatment must be an alternative to sodium cromoglycate; or</p> <p>The treatment must be an alternative to nedocromil sodium; AND</p> <p>Patient must be aged 6 to 14 years inclusive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>First-line prevention</p><br/><p>The condition must be frequent intermittent; or</p> <p>The condition must be mild persistent; AND</p> <p>The treatment must be the single preventer agent; AND</p> <p>The treatment must be an alternative to sodium cromoglycate; or</p> <p>The treatment must be an alternative to nedocromil sodium; AND</p> <p>Patient must be aged 6 to 14 years inclusive.</p> <p align=""justify"">This drug is not PBS-subsidised for use in a patient aged 15 years or older, or for use in addition to a long-acting beta-agonist in any age group, or for use as a single second line preventer, as an alternative to corticosteroids, in a child aged 6 to 14 years with moderate to severe asthma.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6679_6679_R","null","STREAMLINED","6679","6679","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisting bone marrow transplantation</p><br/><p>Patient must be receiving marrow-ablative chemotherapy prior to the transplantation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisting bone marrow transplantation</p><br/><p>Patient must be receiving marrow-ablative chemotherapy prior to the transplantation.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6680_6680_R","null","STREAMLINED","6680","6680","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe congenital neutropenia</p><br/><p>Patient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; AND</p> <p>Patient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe congenital neutropenia</p><br/><p>Patient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; AND</p> <p>Patient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6683_6683_R","null","RESTRICTED","6683","6683","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p><br/><p>The treatment must be for preventing low plasma arginine levels; or</p> <p>The treatment must be for preventing low citrulline levels.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p><br/><p>The treatment must be for preventing low plasma arginine levels; or</p> <p>The treatment must be for preventing low citrulline levels.</p> <p align=""justify"">Citrulline with carbohydrate is not indicated for the treatment of arginase deficiency and other inborn errors of protein metabolism.</p>","N","N","N","IMMEDIATE","ALL","N","2017-01-01","N","4708"
"6706_6706_R","null","RESTRICTED","6706","6706","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>Patient must have had surgery for this condition with incomplete resolution.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p> <p>Pathological hyperprolactinaemia</p><br/><p>Patient must have had surgery for this condition with incomplete resolution.</p>","N","N","N","IMMEDIATE","ALL","N","2017-02-01","N","4708"
"6707_6707_R","null","RESTRICTED","6707","6707","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>Patient must be one in whom radiotherapy is not indicated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p> <p>Pathological hyperprolactinaemia</p><br/><p>Patient must be one in whom radiotherapy is not indicated.</p>","N","N","N","IMMEDIATE","ALL","N","2017-02-01","N","4708"
"6717_6717_R","null","RESTRICTED","6717","6717","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p> <p>Acromegaly</p>","N","N","N","IMMEDIATE","ALL","N","2017-02-01","N","4708"
"6718_6718_R","null","RESTRICTED","6718","6718","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p> <p>Parkinson disease</p>","N","N","N","IMMEDIATE","ALL","N","2017-02-01","N","4708"
"6719_6719_R","null","RESTRICTED","6719","6719","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>Patient must have had radiotherapy for this condition with incomplete resolution.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p> <p>Pathological hyperprolactinaemia</p><br/><p>Patient must have had radiotherapy for this condition with incomplete resolution.</p>","N","N","N","IMMEDIATE","ALL","N","2017-02-01","N","4708"
"6773_6773_R","null","AUTHORITY_REQUIRED","6773","6773","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Panic disorder</p><br/><p>The treatment must be for use when other treatments have failed; or</p> <p>The treatment must be for use when other treatments are inappropriate.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Panic disorder</p><br/><p>The treatment must be for use when other treatments have failed; or</p> <p>The treatment must be for use when other treatments are inappropriate.</p> <p align=""justify"">The panic disorder must not be attributable to some known organic factor.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2017-02-01","N","4708"
"6786_6786_R","null","AUTHORITY_REQUIRED","6786","6786","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Rehydration in intestinal failure</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Rehydration in intestinal failure</p>","N","N","N","IMMEDIATE","ALL","N","2023-01-01","N","4708"
"6787_6787_R","null","RESTRICTED","6787","6787","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hyperprolactinaemia</p><br/><p>Patient must be one in whom surgery is not indicated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.</p> <p>Pathological hyperprolactinaemia</p><br/><p>Patient must be one in whom surgery is not indicated.</p>","N","N","N","IMMEDIATE","ALL","N","2017-02-01","N","4708"
"6812_6812_R","null","RESTRICTED","6812","6812","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","N","N","N","IMMEDIATE","ALL","N","2017-04-01","N","4708"
"6815_6815_R","null","RESTRICTED","6815","6815","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.</p> <p align=""justify"">Pharmaceutical benefits that have a 30 x 2 pack size and a 20 x 3 pack size are equivalent for the purposes of substitution<b><i>.</i></b></p>","N","N","N","IMMEDIATE","ALL","N","2017-04-01","N","4708"
"6847_6847_R","Continuing treatment","STREAMLINED","6847","6847","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must not receive more than one PBS-subsidised treatment per year; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a neurologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must not receive more than one PBS-subsidised treatment per year; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a neurologist.</p> <p align=""left"">Neurologists prescribing PBS-subsidised alemtuzumab must be registered with the Lemtrada monitoring program.</p> <p align=""justify"">Special Pricing Arrangements apply.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2017-05-01","N","4708"
"6852_6852_R","null","STREAMLINED","6852","6852","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.</p> <p align=""justify"">No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.</p> <p align=""justify"">Concomitant use of a 5HT3 antagonist should not occur with fosaprepitant on days 2 and 3 of any chemotherapy cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.</p> <p align=""justify"">No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.</p> <p align=""justify"">Concomitant use of a 5HT3 antagonist should not occur with fosaprepitant on days 2 and 3 of any chemotherapy cycle.</p> <p align=""justify"">This medicine is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2017-05-01","N","4708"
"6871_6871_R","Commencement of a short-term (12 weeks or 24 weeks) course of treatment","STREAMLINED","6871","6871","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>Commencement of a short-term (12 weeks or 24 weeks) course of treatment</p><br/><p>The treatment must be as an aid to achieving abstinence from smoking; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have indicated they are ready to cease smoking; AND</p> <p>Patient must not receive more than 24 weeks of PBS-subsidised treatment with this drug per 12-month period; AND</p> <p>Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program or is about to enter such a program at the time PBS-subsidised treatment is initiated.</p> <p align=""justify"">Details of the support and counselling program must be documented in the patient&apos;s medical records at the time treatment is initiated.</p> <p align=""justify"">Clinical review is recommended within 2 to 3 weeks of the initial prescription being requested.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>Commencement of a short-term (12 weeks or 24 weeks) course of treatment</p><br/><p>The treatment must be as an aid to achieving abstinence from smoking; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have indicated they are ready to cease smoking; AND</p> <p>Patient must not receive more than 24 weeks of PBS-subsidised treatment with this drug per 12-month period; AND</p> <p>Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program or is about to enter such a program at the time PBS-subsidised treatment is initiated.</p> <p align=""justify"">Details of the support and counselling program must be documented in the patient&apos;s medical records at the time treatment is initiated.</p> <p align=""justify"">Clinical review is recommended within 2 to 3 weeks of the initial prescription being requested.</p> <p align=""justify"">A course of treatment with this drug is 12 weeks or up to 24 weeks, if initial treatment of 12 weeks has been successful.</p> <p align=""justify"">The period between commencing varenicline and bupropion or a new course of varenicline must be at least 6 months. </p> <p align=""justify"">A patient may only qualify for PBS-subsidised treatment under this treatment phase restriction once during a short-term course of treatment.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2017-05-01","N","4708"
"6881_6881_R","Completion of a short-term (9 weeks) course of treatment","STREAMLINED","6881","6881","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>Completion of a short-term (9 weeks) course of treatment</p><br/><p>The treatment must be as an aid to achieving abstinence from smoking; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug during this current course of treatment; AND</p> <p>Patient must not receive more than 9 weeks of PBS-subsidised treatment with this drug per 12-month period; AND</p> <p>Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>Completion of a short-term (9 weeks) course of treatment</p><br/><p>The treatment must be as an aid to achieving abstinence from smoking; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug during this current course of treatment; AND</p> <p>Patient must not receive more than 9 weeks of PBS-subsidised treatment with this drug per 12-month period; AND</p> <p>Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program.</p> <p align=""justify"">Clinical review is recommended within 2 to 3 weeks of the original prescription being requested.</p> <p align=""justify"">The period between commencing a course of bupropion hydrochloride and varenicline tartrate must be at least 6 months. </p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2017-05-01","N","4708"
"6882_6882_R","Commencement of a short-term (9 weeks) course of treatment","STREAMLINED","6882","6882","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>Commencement of a short-term (9 weeks) course of treatment</p><br/><p>The treatment must be as an aid to achieving abstinence from smoking; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have indicated they are ready to cease smoking; AND</p> <p>Patient must not receive more than 9 weeks of PBS-subsidised treatment with this drug per 12-month period; AND</p> <p>Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program or is about to enter such a program at the time PBS-subsidised treatment is initiated.</p> <p align=""justify"">Details of the support and counselling program must be documented in the patient&apos;s medical records at the time treatment is initiated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>Commencement of a short-term (9 weeks) course of treatment</p><br/><p>The treatment must be as an aid to achieving abstinence from smoking; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have indicated they are ready to cease smoking; AND</p> <p>Patient must not receive more than 9 weeks of PBS-subsidised treatment with this drug per 12-month period; AND</p> <p>Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program or is about to enter such a program at the time PBS-subsidised treatment is initiated.</p> <p align=""justify"">Details of the support and counselling program must be documented in the patient&apos;s medical records at the time treatment is initiated.</p> <p align=""justify"">Clinical review is recommended within 2 to 3 weeks of the original prescription being requested.</p> <p align=""justify"">The period between commencing a course of bupropion hydrochloride and varenicline tartrate must be at least 6 months. </p> <p align=""justify"">A patient may only qualify for PBS-subsidised treatment under this treatment phase restriction once during a short-term course of treatment.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2017-05-01","N","4708"
"6885_6885_R","Completion of a short-term (24 weeks) course of treatment","STREAMLINED","6885","6885","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>Completion of a short-term (24 weeks) course of treatment</p><br/><p>The treatment must be as an aid to achieving abstinence from smoking; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug during this current course of treatment; AND</p> <p>Patient must have ceased smoking in the process of completing an initial 12-weeks or ceased smoking following an initial 12-weeks of PBS-subsidised treatment with this drug in the current course of treatment; AND</p> <p>Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>Completion of a short-term (24 weeks) course of treatment</p><br/><p>The treatment must be as an aid to achieving abstinence from smoking; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug during this current course of treatment; AND</p> <p>Patient must have ceased smoking in the process of completing an initial 12-weeks or ceased smoking following an initial 12-weeks of PBS-subsidised treatment with this drug in the current course of treatment; AND</p> <p>Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program.</p> <p align=""justify"">A course of treatment with this drug is 12 weeks or up to 24 weeks, if initial treatment of 12 weeks has been successful.</p> <p align=""justify"">A patient may only qualify for PBS-subsidised treatment under this treatment phase restriction once during a short-term course of treatment.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2017-05-01","N","4708"
"6886_6886_R","null","STREAMLINED","6886","6886","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin.</p> <p align=""justify"">No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin.</p> <p align=""justify"">No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.</p> <p align=""justify"">This medicine is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2017-05-01","N","4708"
"6887_6887_R","null","STREAMLINED","6887","6887","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND</p> <p>Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.</p> <p align=""justify"">No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.</p> <p align=""justify"">Concomitant use of a 5HT3 antagonist should not occur with fosaprepitant on days 2 and 3 of any chemotherapy cycle.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND</p> <p>Patient must have had a prior episode of chemotherapy induced nausea or vomiting; AND</p> <p>Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents: arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.</p> <p align=""justify"">No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.</p> <p align=""justify"">Concomitant use of a 5HT3 antagonist should not occur with fosaprepitant on days 2 and 3 of any chemotherapy cycle.</p> <p align=""justify"">This medicine is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2017-05-01","N","4708"
"6891_6891_R","null","STREAMLINED","6891","6891","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND</p> <p>Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.</p> <p align=""justify"">No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nausea and vomiting</p><br/><p>The condition must be associated with cytotoxic chemotherapy being used to treat breast cancer; AND</p> <p>The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND</p> <p>Patient must be scheduled to be co-administered cyclophosphamide and an anthracycline.</p> <p align=""justify"">No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.</p> <p align=""justify"">This medicine is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2017-05-01","N","4708"
"6910_6910_R","null","AUTHORITY_REQUIRED","6910","6910","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>Patient must have an established pituitary or testicular disorder; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Androgen deficiency</p><br/><p>Patient must have an established pituitary or testicular disorder; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2017-06-01","N","4708"
"6918_C","null","null","null","null","null","<p>There are reports of fatal hepatotoxicity, particularly in children.</p><p> There is increasing evidence of dose-related teratogenesis from this drug.</p>","N","Y","N","null","null","N","2006-12-01","N","4708"
"6919_6919_R","null","AUTHORITY_REQUIRED","6919","6919","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pubertal induction</p><br/><p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pubertal induction</p><br/><p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2017-06-01","N","4708"
"6933_6933_R","null","AUTHORITY_REQUIRED","6933","6933","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Micropenis</p><br/><p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Micropenis</p><br/><p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2017-06-01","N","4708"
"6934_6934_R","null","AUTHORITY_REQUIRED","6934","6934","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constitutional delay of growth or puberty</p><br/><p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constitutional delay of growth or puberty</p><br/><p>Patient must be under 18 years of age; AND</p> <p>Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.</p> <p align=""justify"">The name of the specialist must be included in the authority application.</p>","N","N","N","IMMEDIATE","ALL","N","2017-06-01","N","4708"
"6945_C","null","null","null","null","null","<p>Prochlorperazine may be associated with parkinsonism and tardive dyskinesia and should be used for short-term treatment only.</p>","N","Y","N","null","null","N","1995-04-01","N","4708"
"6953_6953_R","null","STREAMLINED","6953","6953","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urinary incontinence</p><br/><p>Must be treated by a urologist; or</p> <p>Must be treated by a gynaecologist; AND</p> <p>The condition must be due to idiopathic overactive bladder; AND</p> <p>The condition must have been inadequately controlled by therapy involving at least two alternative anti-cholinergic agents; AND</p> <p>Patient must experience at least 14 episodes of urinary incontinence per week prior to commencement of treatment with botulinum toxin type A neurotoxin complex; AND</p> <p>Patient must be willing and able to self-catheterise; AND</p> <p>The treatment must not continue if the patient does not achieve a 50% or greater reduction from baseline in urinary incontinence episodes 6-12 weeks after the first treatment; AND</p> <p>Patient must be aged 18 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Contraindications to treatment include known sensitivity to botulinum toxin.</p> <p>Urinary incontinence</p><br/><p>Must be treated by a urologist; or</p> <p>Must be treated by a gynaecologist; AND</p> <p>The condition must be due to idiopathic overactive bladder; AND</p> <p>The condition must have been inadequately controlled by therapy involving at least two alternative anti-cholinergic agents; AND</p> <p>Patient must experience at least 14 episodes of urinary incontinence per week prior to commencement of treatment with botulinum toxin type A neurotoxin complex; AND</p> <p>Patient must be willing and able to self-catheterise; AND</p> <p>The treatment must not continue if the patient does not achieve a 50% or greater reduction from baseline in urinary incontinence episodes 6-12 weeks after the first treatment; AND</p> <p>Patient must be aged 18 years or older.</p> <p>The units used to express the potency of botulinum toxin preparations currently available for PBS subsidy are not equivalent.</p> <p align=""justify"">Special Pricing Arrangements apply.</p>","N","N","N","IMMEDIATE","ALL","N","2017-07-01","N","4708"
"6980_6980_R","null","STREAMLINED","6980","6980","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must have cirrhosis; AND</p> <p>Patient must be nucleoside analogue naive; AND</p> <p>Patient must have detectable HBV DNA; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Patients with Child&apos;s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must have cirrhosis; AND</p> <p>Patient must be nucleoside analogue naive; AND</p> <p>Patient must have detectable HBV DNA; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Patients with Child&apos;s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.</p> <p>Patients may receive treatment in combination with lamivudine but not with other PBS-subsidised antihepadnaviral therapy.</p> <p align=""justify"">Pharmaceutical benefits that have the forms tenofovir disoproxil phosphate 291 mg tablet, tenofovir disoproxil maleate 300 mg tablet, and tenofovir disoproxil fumarate 300 mg tablet are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2017-08-01","N","4708"
"6982_6982_R","Continuing","STREAMLINED","6982","6982","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p> <p align=""justify"">Pharmaceutical benefits that have the forms tenofovir disoproxil phosphate 291 mg tablet, tenofovir disoproxil maleate 300 mg tablet, and tenofovir disoproxil fumarate 300 mg tablet are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2017-08-01","N","4708"
"6983_6983_R","null","STREAMLINED","6983","6983","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must have cirrhosis; AND</p> <p>Patient must have failed antihepadnaviral therapy; AND</p> <p>Patient must have detectable HBV DNA.</p> <p align=""justify"">Patients with Child&apos;s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must have cirrhosis; AND</p> <p>Patient must have failed antihepadnaviral therapy; AND</p> <p>Patient must have detectable HBV DNA.</p> <p align=""justify"">Patients with Child&apos;s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.</p> <p>Patients may receive treatment in combination with lamivudine but not with other PBS-subsidised antihepadnaviral therapy.</p> <p align=""justify"">Pharmaceutical benefits that have the forms tenofovir disoproxil phosphate 291 mg tablet, tenofovir disoproxil maleate 300 mg tablet, and tenofovir disoproxil fumarate 300 mg tablet are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2017-08-01","N","4708"
"6984_6984_R","null","STREAMLINED","6984","6984","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must not have cirrhosis; AND</p> <p>Patient must have failed antihepadnaviral therapy; AND</p> <p>Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; or</p> <p>Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must not have cirrhosis; AND</p> <p>Patient must have failed antihepadnaviral therapy; AND</p> <p>Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; or</p> <p>Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance.</p> <p>Patients may receive treatment in combination with lamivudine but not with other PBS-subsidised antihepadnaviral therapy.</p> <p align=""justify"">Pharmaceutical benefits that have the forms tenofovir disoproxil phosphate 291 mg tablet, tenofovir disoproxil maleate 300 mg tablet, and tenofovir disoproxil fumarate 300 mg tablet are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2017-08-01","N","4708"
"6992_6992_R","null","STREAMLINED","6992","6992","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must not have cirrhosis; AND</p> <p>Patient must be nucleoside analogue naive; AND</p> <p>Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; or</p> <p>Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND</p> <p>Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis B infection</p><br/><p>Patient must not have cirrhosis; AND</p> <p>Patient must be nucleoside analogue naive; AND</p> <p>Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; or</p> <p>Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND</p> <p>Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p>Patients may receive treatment in combination with lamivudine but not with other PBS-subsidised antihepadnaviral therapy.</p> <p align=""justify"">Pharmaceutical benefits that have the forms tenofovir disoproxil phosphate 291 mg tablet, tenofovir disoproxil maleate 300 mg tablet, and tenofovir disoproxil fumarate 300 mg tablet are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2017-08-01","N","4708"
"6998_6998_R","Initial","STREAMLINED","6998","6998","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p> <p align=""justify"">Pharmaceutical benefits that have the forms tenofovir disoproxil phosphate 291 mg tablet, tenofovir disoproxil maleate 300 mg tablet, and tenofovir disoproxil fumarate 300 mg tablet are equivalent for the purposes of substitution.</p>","N","N","N","IMMEDIATE","ALL","N","2017-08-01","N","4708"
"7025_7025_R","null","STREAMLINED","7025","7025","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>The condition must be active; AND</p> <p>Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND</p> <p>The treatment must be after failure of other therapy including dopamine agonists; or</p> <p>The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or</p> <p>The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised pegvisomant.</p> <p align=""justify"">In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>The condition must be active; AND</p> <p>Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND</p> <p>The treatment must be after failure of other therapy including dopamine agonists; or</p> <p>The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or</p> <p>The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised pegvisomant.</p> <p align=""justify"">In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. </p>","N","N","N","IMMEDIATE","ALL","N","2017-09-01","N","4708"
"7092_6989_R","null","RESTRICTED","6989","7092","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anovulatory infertility</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anovulatory infertility</p> <p align=""justify"">Except in cases of hypopituitarism or primary amenorrhoea, the patient should have been adequately treated with clomifene citrate and/or gonadorelin and failed to have conceived.</p> <p align=""justify"">Women who have had apparent ovulation induced by other agents and have failed to conceive should have laparoscopic evidence that there is no other impediment to conception. </p> <p>Oligomenorrhoea should have been present for at least twelve months or amenorrhoea for at least six months prior to treatment.</p> <p align=""justify"">Patients with hyperprolactinaemia should have had appropriate surgical or medical treatment prior to treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2017-10-01","N","4708"
"7105_6990_R","null","RESTRICTED","6990","7105","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infertility</p><br/><p>Patient must be male; AND</p> <p>The condition must be associated with isolated luteinising hormone deficiency.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infertility</p><br/><p>Patient must be male; AND</p> <p>The condition must be associated with isolated luteinising hormone deficiency.</p> <p align=""justify"">Patients with hyperprolactinaemia should have had appropriate surgical or medical treatment prior to treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2017-10-01","N","4708"
"7108_6991_R","null","STREAMLINED","6991","7108","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisted Reproductive Technology</p><br/><p>Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule.</p>","N","N","N","IMMEDIATE","ALL","N","2017-10-01","N","4708"
"7110_6987_R","null","RESTRICTED","6987","7110","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infertility</p><br/><p>Patient must be male; AND</p> <p>The condition must be due to hypogonadotrophic hypogonadism.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Infertility</p><br/><p>Patient must be male; AND</p> <p>The condition must be due to hypogonadotrophic hypogonadism.</p> <p align=""justify"">Patients with hyperprolactinaemia should have had appropriate surgical or medical treatment prior to treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2017-10-01","N","4708"
"7111_6979_R","null","RESTRICTED","6979","7111","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined deficiency of human growth hormone and gonadotrophins</p><br/><p>Patient must be male; AND</p> <p>Patient must be one in whom the absence of secondary sexual characteristics indicates a lag in maturation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Combined deficiency of human growth hormone and gonadotrophins</p><br/><p>Patient must be male; AND</p> <p>Patient must be one in whom the absence of secondary sexual characteristics indicates a lag in maturation.</p> <p align=""justify"">Patients with hyperprolactinaemia should have had appropriate surgical or medical treatment prior to treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2017-10-01","N","4708"
"7112_6995_R","null","RESTRICTED","6995","7112","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypogonadism or delayed puberty</p><br/><p>Patient must be male; AND</p> <p>Patient must be aged 16 years or older; AND</p> <p>Patient must show clinical evidence of the condition; AND</p> <p>The treatment must not extend beyond 6 months.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypogonadism or delayed puberty</p><br/><p>Patient must be male; AND</p> <p>Patient must be aged 16 years or older; AND</p> <p>Patient must show clinical evidence of the condition; AND</p> <p>The treatment must not extend beyond 6 months.</p> <p align=""justify"">Patients with hyperprolactinaemia should have had appropriate surgical or medical treatment prior to treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2017-10-01","N","4708"
"7134_7134_R","null","STREAMLINED","7134","7134","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to multiple sclerosis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to multiple sclerosis.</p>","N","N","N","IMMEDIATE","ALL","N","2017-11-01","N","4708"
"7148_7148_R","null","STREAMLINED","7148","7148","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord disease.</p>","N","N","N","IMMEDIATE","ALL","N","2017-11-01","N","4708"
"7152_7152_R","null","STREAMLINED","7152","7152","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity of cerebral origin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity of cerebral origin.</p>","N","N","N","IMMEDIATE","ALL","N","2017-11-01","N","4708"
"7153_7153_R","null","STREAMLINED","7153","7153","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord injury.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord injury.</p>","N","N","N","IMMEDIATE","ALL","N","2017-11-01","N","4708"
"7163_7274_R","Continuing","AUTHORITY_REQUIRED","7274","7163","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anticipated emergency treatment of an acute attack of hereditary angioedema</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to 12 injections per authority prescription.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anticipated emergency treatment of an acute attack of hereditary angioedema</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <p align=""justify"">Icatibant should be provided in the framework of a comprehensive hereditary angioedema prophylaxis program and an emergency Action Plan including training in recognition of the symptoms of hereditary angioedema and the self-administration of icatibant. (For further information see the Australasian Society of Clinical Immunology and Allergy website at www.allergy.org.au)</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to 12 injections per authority prescription.</p>","N","N","N","IMMEDIATE","ALL","Y","2017-12-01","N","4708"
"7192_5838_R","null","RESTRICTED","5838","7192","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pernicious anaemia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pernicious anaemia</p>","N","N","N","IMMEDIATE","ALL","N","2017-12-01","N","4708"
"7193_5839_R","null","RESTRICTED","5839","7193","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaemias associated with vitamin B12 deficiency</p><br/><p>Patient must have had a gastrectomy; AND</p> <p>The treatment must be for prophylaxis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaemias associated with vitamin B12 deficiency</p><br/><p>Patient must have had a gastrectomy; AND</p> <p>The treatment must be for prophylaxis.</p>","N","N","N","IMMEDIATE","ALL","N","2017-12-01","N","4708"
"7241_5880_R","null","RESTRICTED","5880","7241","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven vitamin B12 deficiencies other than pernicious anaemia</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Proven vitamin B12 deficiencies other than pernicious anaemia</p>","N","N","N","IMMEDIATE","ALL","N","2017-12-01","N","4708"
"7246_7273_R","Initial","AUTHORITY_REQUIRED","7273","7246","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anticipated emergency treatment of an acute attack of hereditary angioedema</p><br/><p>Initial</p><br/><p>Patient must have confirmed diagnosis of C1-esterase inhibitor deficiency; AND</p> <p>Patient must have been assessed to be at significant risk of an acute attack of hereditary angioedema; AND</p> <p>The condition must be assessed by a clinical immunologist; or</p> <p>The condition must be assessed by a respiratory physician; or</p> <p>The condition must be assessed by a specialist allergist; or</p> <p>The condition must be assessed by a general physician experienced in the management of patients with hereditary angioedema.</p> <p align=""justify"">The name of the specialist consulted must be provided at the time of application for initial supply.</p> <p align=""justify"">The date of the pathology report and name of the Approved Pathology Authority must be provided at the time of application.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to 12 injections per authority prescription.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anticipated emergency treatment of an acute attack of hereditary angioedema</p><br/><p>Initial</p><br/><p>Patient must have confirmed diagnosis of C1-esterase inhibitor deficiency; AND</p> <p>Patient must have been assessed to be at significant risk of an acute attack of hereditary angioedema; AND</p> <p>The condition must be assessed by a clinical immunologist; or</p> <p>The condition must be assessed by a respiratory physician; or</p> <p>The condition must be assessed by a specialist allergist; or</p> <p>The condition must be assessed by a general physician experienced in the management of patients with hereditary angioedema.</p> <p align=""justify"">The name of the specialist consulted must be provided at the time of application for initial supply.</p> <p align=""justify"">The date of the pathology report and name of the Approved Pathology Authority must be provided at the time of application.</p> <p align=""justify"">Icatibant should be provided in the framework of a comprehensive hereditary angioedema prophylaxis program and an emergency Action Plan including training in recognition of the symptoms of hereditary angioedema and the self-administration of icatibant. (For further information see the Australasian Society of Clinical Immunology and Allergy website at www.allergy.org.au)</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Increased maximum quantities will be limited to 12 injections per authority prescription.</p>","N","N","N","IMMEDIATE","ALL","Y","2017-12-01","N","4708"
"7281_7275_R","null","RESTRICTED","7275","7281","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a highly restrictive therapeutic diet</p><br/><p>Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND</p> <p>Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations; AND</p> <p>Patient must be aged 3 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dietary management of conditions requiring a highly restrictive therapeutic diet</p><br/><p>Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND</p> <p>Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations; AND</p> <p>Patient must be aged 3 years or older.</p> <p align=""justify"">Phlexy-Vits must only be used under strict supervision of a dietician and a paediatrician.</p>","N","N","N","IMMEDIATE","ALL","N","2017-12-01","N","4708"
"7354_5634_R","null","STREAMLINED","5634","7354","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; or</p> <p>Patient must have significant bronchiectasis on chest high resolution computed tomography scan; or</p> <p>Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; or</p> <p>Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy; AND</p> <p>Patient must be less than 5 years of age.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; or</p> <p>Patient must have significant bronchiectasis on chest high resolution computed tomography scan; or</p> <p>Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; or</p> <p>Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy; AND</p> <p>Patient must be less than 5 years of age.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals.</p> <p>It is highly desirable that all patients be included in the national cystic fibrosis patient database.</p>","N","N","N","IMMEDIATE","ALL","N","2018-01-01","N","4708"
"7361_7362_R","null","STREAMLINED","7362","7361","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must be intolerant or inadequately responsive to dornase alfa; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.</p> <p align=""justify"">Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.</p> <p align=""justify"">To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:</p><p align=""justify"">(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND</p><p align=""justify"">(2) the patient or the patient&apos;s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must be intolerant or inadequately responsive to dornase alfa; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.</p> <p align=""justify"">Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.</p> <p align=""justify"">To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:</p><p align=""justify"">(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND</p><p align=""justify"">(2) the patient or the patient&apos;s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. </p> <p>It is highly desirable that all patients be included in the national cystic fibrosis patient database.</p>","N","N","N","IMMEDIATE","ALL","N","2018-01-01","N","4708"
"7365_5740_R","null","STREAMLINED","5740","7365","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Patient must be 5 years of age or older.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.</p> <p align=""justify"">Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily.</p> <p align=""justify"">To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:</p><p align=""justify"">(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND</p><p align=""justify"">(2) the patient or the patient&apos;s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Patient must be 5 years of age or older.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.</p> <p align=""justify"">Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily.</p> <p align=""justify"">To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:</p><p align=""justify"">(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND</p><p align=""justify"">(2) the patient or the patient&apos;s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. </p> <p>It is highly desirable that all patients be included in the national cystic fibrosis patient database.</p>","N","N","N","IMMEDIATE","ALL","N","2018-01-01","N","4708"
"7366_7367_R","null","STREAMLINED","7367","7366","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>The treatment must be in combination with dornase alfa; AND</p> <p>Patient must be inadequately responsive to dornase alfa; AND</p> <p>Patient must have trialled hypertonic saline for this condition; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.</p> <p align=""justify"">Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.</p> <p align=""justify"">To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:</p><p align=""justify"">(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND</p><p align=""justify"">(2) the patient or the patient&apos;s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>The treatment must be in combination with dornase alfa; AND</p> <p>Patient must be inadequately responsive to dornase alfa; AND</p> <p>Patient must have trialled hypertonic saline for this condition; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.</p> <p align=""justify"">Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.</p> <p align=""justify"">To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:</p><p align=""justify"">(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND</p><p align=""justify"">(2) the patient or the patient&apos;s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. </p> <p>It is highly desirable that all patients be included in the national cystic fibrosis patient database.</p>","N","N","N","IMMEDIATE","ALL","N","2018-01-01","N","4708"
"7370_5635_R","Continuing treatment","STREAMLINED","5635","7370","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have initiated treatment with dornase alfa at an age of less than 5 years; AND</p> <p>Patient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit; AND</p> <p>Patient must be 5 years of age or older.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have initiated treatment with dornase alfa at an age of less than 5 years; AND</p> <p>Patient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit; AND</p> <p>Patient must be 5 years of age or older.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.</p> <p>It is highly desirable that all patients be included in the national cystic fibrosis patient database.</p>","N","N","N","IMMEDIATE","ALL","N","2018-01-01","N","4708"
"7371_4909_R","Initial sole PBS-subsidised supply for anticipated emergency treatment","AUTHORITY_REQUIRED","4909","7371","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute allergic reaction with anaphylaxis</p><br/><p>Initial sole PBS-subsidised supply for anticipated emergency treatment</p><br/><p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a clinical immunologist; or</p> <p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with an allergist; or</p> <p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a paediatrician; or</p> <p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a respiratory physician.</p> <p align=""justify"">The name of the specialist consulted must be provided at the time of application for initial supply.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute allergic reaction with anaphylaxis</p><br/><p>Initial sole PBS-subsidised supply for anticipated emergency treatment</p><br/><p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a clinical immunologist; or</p> <p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with an allergist; or</p> <p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a paediatrician; or</p> <p>Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a respiratory physician.</p> <p align=""justify"">The name of the specialist consulted must be provided at the time of application for initial supply.</p>","N","N","N","IMMEDIATE","ALL","N","2018-01-01","N","4708"
"7396_7386_R","Continuing treatment","STREAMLINED","7386","7396","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a neurologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a neurologist.</p>","N","N","N","IMMEDIATE","ALL","N","2018-02-01","N","4708"
"7470_7483_R","Continuation of a short-term (12 weeks or 24 weeks) course of treatment","STREAMLINED","7483","7470","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>Continuation of a short-term (12 weeks or 24 weeks) course of treatment</p><br/><p>The treatment must be as an aid to achieving abstinence from smoking; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received treatment with this drug during this current course of treatment; AND</p> <p>Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nicotine dependence</p><br/><p>Continuation of a short-term (12 weeks or 24 weeks) course of treatment</p><br/><p>The treatment must be as an aid to achieving abstinence from smoking; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have previously received treatment with this drug during this current course of treatment; AND</p> <p>Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program.</p> <p align=""justify"">A course of treatment with this drug is 12 weeks or up to 24 weeks, if initial treatment of 12 weeks has been successful.</p> <p align=""justify"">A patient may only qualify for PBS-subsidised treatment under this treatment phase restriction once during a short-term course of treatment.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2018-03-01","N","4708"
"7473_7447_R","Continuing treatment","STREAMLINED","7447","7473","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must not have progressive disease.</p>","N","N","N","IMMEDIATE","ALL","N","2018-03-01","N","4708"
"7474_7446_R","Continuing treatment","STREAMLINED","7446","7474","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must not have progressive disease; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must not have progressive disease; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material.</p>","N","N","N","IMMEDIATE","ALL","N","2018-03-01","N","4708"
"7475_7487_R","Continuing treatment beyond 3 months","STREAMLINED","7487","7475","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p align=""justify"">Special Pricing Arrangements apply.</p>","N","N","N","IMMEDIATE","ALL","N","2018-03-01","N","4708"
"7476_7433_R","Continuing treatment beyond 3 months","STREAMLINED","7433","7476","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Prescribers may request an increased maximum quantity sufficient to provide up to one month&apos;s supply for patients who require dose adjustment. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p align=""justify"">Special Pricing Arrangements apply.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Prescribers may request an increased maximum quantity sufficient to provide up to one month&apos;s supply for patients who require dose adjustment. </p>","N","N","N","IMMEDIATE","ALL","Y","2018-03-01","N","4708"
"7484_7484_R","null","RESTRICTED","7484","7484","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypsarrhythmia and/or infantile spasms</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypsarrhythmia and/or infantile spasms</p>","N","N","N","IMMEDIATE","ALL","N","2018-03-01","N","4708"
"7488_7488_R","null","STREAMLINED","7488","7488","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Patient must be unsuitable for administration of an oral form of methotrexate for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Patient must be unsuitable for administration of an oral form of methotrexate for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2018-04-01","N","4708"
"7518_7518_R","null","STREAMLINED","7518","7518","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriasis</p><br/><p>The condition must not have adequately responded to topical treatment; AND</p> <p>Patient must be unsuitable for administration of an oral form of methotrexate for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriasis</p><br/><p>The condition must not have adequately responded to topical treatment; AND</p> <p>Patient must be unsuitable for administration of an oral form of methotrexate for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2018-04-01","N","4708"
"7566_7566_R","null","AUTHORITY_REQUIRED","7566","7566","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-infectious posterior segment uveitis</p><br/><p>Must be treated by an ophthalmologist or in consultation with an ophthalmologist; AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score of approximate Snellen equivalent 6/12 or worse in the eye proposed for treatment, secondary to vitreous haze or macular oedema; AND</p> <p>Patient must have unilateral, asymmetric or bilateral flare-up where systemic treatment or further intensification of systemic treatment is not clinically indicated.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-infectious posterior segment uveitis</p><br/><p>Must be treated by an ophthalmologist or in consultation with an ophthalmologist; AND</p> <p>Patient must have documented visual impairment defined as a best corrected visual acuity score of approximate Snellen equivalent 6/12 or worse in the eye proposed for treatment, secondary to vitreous haze or macular oedema; AND</p> <p>Patient must have unilateral, asymmetric or bilateral flare-up where systemic treatment or further intensification of systemic treatment is not clinically indicated.</p>","N","N","N","IMMEDIATE","ALL","N","2018-04-01","N","4708"
"7600_7613_R","Continuing treatment","STREAMLINED","7613","7600","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing treatment</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material.</p> <p align=""justify"">Special Pricing Arrangements apply.</p>","N","N","N","IMMEDIATE","ALL","N","2018-05-01","N","4708"
"7601_7593_R","null","AUTHORITY_REQUIRED","7593","7601","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 8 weeks.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 8 weeks.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p align=""justify"">Special Pricing Arrangements apply.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7606_N","null","null","null","null","null","<p>No increase in the maximum quantity or number of units may be authorised.</p>","Y","N","N","null","null","N","2012-10-01","N","4708"
"7607_N","null","null","null","null","null","<p>No increase in the maximum number of repeats may be authorised.</p>","Y","N","N","null","null","N","2012-10-01","N","4708"
"7608_N","null","null","null","null","null","<p align=""justify"">Special Pricing Arrangements apply.</p>","Y","N","N","null","null","N","2012-10-01","N","4708"
"7614_7615_R","null","AUTHORITY_REQUIRED","7615","7614","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 12 weeks.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic hepatitis C infection</p><br/><p>Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND</p> <p>Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND</p> <p>The treatment must be limited to a maximum duration of 12 weeks.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p> <p align=""justify"">Special Pricing Arrangements apply.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7614_N","null","null","null","null","null","<p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p>","Y","N","N","null","null","N","2012-10-01","N","4708"
"7617_4415_R","null","AUTHORITY_REQUIRED","4415","7617","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe intestinal malabsorption including short bowel syndrome</p><br/><p>Patient must have failed to respond to protein hydrolysate formulae; or</p> <p>Patient must have been receiving parenteral nutrition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe intestinal malabsorption including short bowel syndrome</p><br/><p>Patient must have failed to respond to protein hydrolysate formulae; or</p> <p>Patient must have been receiving parenteral nutrition.</p> <p align=""justify"">A risk/benefit analysis prior to treatment, and continuous patient monitoring from a health care professional is required for the use of this product, for this indication.</p> <p/><p align=""justify"">Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. </p><p/>","N","N","N","IMMEDIATE","ALL","N","2018-05-01","N","4708"
"7630_4351_R","Initial treatment","AUTHORITY_REQUIRED","4351","7630","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tuberous sclerosis complex (TSC)</p><br/><p>Initial treatment</p><br/><p>The condition must be subependymal giant cell astrocytomas (SEGAs) associated with TSC; or</p> <p>The condition must be visceral tumours associated with TSC; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not be a candidate for curative surgical resection.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tuberous sclerosis complex (TSC)</p><br/><p>Initial treatment</p><br/><p>The condition must be subependymal giant cell astrocytomas (SEGAs) associated with TSC; or</p> <p>The condition must be visceral tumours associated with TSC; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must not be a candidate for curative surgical resection.</p>","N","N","N","IMMEDIATE","ALL","N","2018-06-01","N","4708"
"7641_7431_R","Continuing treatment","STREAMLINED","7431","7641","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tuberous sclerosis complex (TSC)</p><br/><p>Continuing treatment</p><br/><p>The condition must be subependymal giant cell astrocytomas (SEGAs) associated with TSC; or</p> <p>The condition must be visceral tumours associated with TSC; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have demonstrated a response to prior treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Tuberous sclerosis complex (TSC)</p><br/><p>Continuing treatment</p><br/><p>The condition must be subependymal giant cell astrocytomas (SEGAs) associated with TSC; or</p> <p>The condition must be visceral tumours associated with TSC; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have demonstrated a response to prior treatment.</p>","N","N","N","IMMEDIATE","ALL","N","2018-06-01","N","4708"
"7646_4812_R","null","AUTHORITY_REQUIRED","4812","7646","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) breast cancer</p><br/><p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must have acquired endocrine resistance as demonstrated by initial response and then recurrence or progression of disease after treatment with letrozole or anastrozole; AND</p> <p>The treatment must be in combination with exemestane; AND</p> <p>Patient must not be pre-menopausal.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) breast cancer</p><br/><p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must have acquired endocrine resistance as demonstrated by initial response and then recurrence or progression of disease after treatment with letrozole or anastrozole; AND</p> <p>The treatment must be in combination with exemestane; AND</p> <p>Patient must not be pre-menopausal.</p> <p/><p align=""justify"">Patients who have progressive disease with everolimus are no longer eligible for PBS-subsidised everolimus.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2018-06-01","N","4708"
"7647_7432_R","Continuing treatment beyond 3 months","STREAMLINED","7432","7647","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2018-06-01","N","4708"
"7708_N","null","null","null","null","null","<p>One injection of hydroxocobalamin 1 mg every three months provides appropriate maintenance therapy in vitamin B<sub>12</sub> deficiencies.</p>","Y","N","N","null","null","N","2012-10-01","N","4708"
"7709_N","null","null","null","null","null","<p>Pharmaceutical benefits that have the form hydroxocobalamin injection 1 mg (as acetate) in 1 mL and pharmaceutical benefits that have the form hydroxocobalamin injection 1 mg (as chloride) in 1 mL are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2012-10-01","N","4708"
"7713_7699_R","Initial treatment","STREAMLINED","7699","7713","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a neurologist.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a neurologist.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2018-07-01","N","4708"
"7758_7714_R","Initial treatment","STREAMLINED","7714","7758","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a neurologist.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a neurologist.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p> <p align=""left"">Neurologists prescribing PBS-subsidised alemtuzumab must be registered with the Lemtrada monitoring program.</p> <p align=""justify"">Special Pricing Arrangements apply.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2018-07-01","N","4708"
"7767_N","null","null","null","null","null","<p align=""justify"">Authority applications for continuing treatment may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","Y","N","Y","null","null","N","2012-10-01","N","4708"
"7772_7798_R","null","STREAMLINED","7798","7772","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA); or</p> <p>Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting beta 2 agonist (LABA); or</p> <p>Patient must have been stabilised on a combination of a LAMA and a LABA.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA); or</p> <p>Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting beta 2 agonist (LABA); or</p> <p>Patient must have been stabilised on a combination of a LAMA and a LABA.</p> <p/><p align=""justify"">This product is not PBS-subsidised for the treatment of asthma.</p><p/> <p/><p align=""justify"">This product is not indicated for the initiation of bronchodilator therapy in COPD. </p><p/> <p align=""justify"">The treatment must not be used in combination with an ICS/LABA, LAMA, LABA, or SAMA</p> <p/><p align=""justify"">A LAMA includes tiotropium, glycopyrronium, aclidinium or umeclidinium.</p><p/> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">A SAMA includes ipratropium</p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7776_6940_R","null","STREAMLINED","6940","7776","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord injury.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord injury.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7776_C","null","null","null","null","null","<p>Careful monitoring of patients is mandatory.</p>","N","Y","N","null","null","N","2012-10-01","N","4708"
"7777_7777_R","Balance of supply","AUTHORITY_REQUIRED","7777","7777","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment) or 2 repeats (first Continuing or Subsequent Continuing treatment).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment) or 2 repeats (first Continuing or Subsequent Continuing treatment).</p> <p align=""justify"">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7782_5889_R","null","RESTRICTED","5889","7782","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For treatment of a patient identifying as Aboriginal or Torres Strait Islander</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7783_4397_R","null","STREAMLINED","4397","7783","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7784_4711_R","null","STREAMLINED","4711","7784","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">This drug is not recommended nor PBS-subsidised for use as &apos;maintenance and reliever&apos; therapy.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7785_4395_R","null","STREAMLINED","4395","7785","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">Flutiform is not recommended nor PBS-subsidised for use as &apos;maintenance and reliever&apos; therapy.</p> <p align=""justify"">Flutiform is not indicated or PBS-subsidised for bronchodilator therapy in COPD. </p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7793_6366_R","null","RESTRICTED","6366","7793","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p> <p>This drug is not PBS-subsidised for the treatment of asthma.</p> <p align=""justify"">The treatment must not be used in combination with an ICS/LABA, or LAMA/LABA</p> <p align=""justify"">A LAMA/LABA includes aclidinium/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, or umeclidinium/vilanterol.</p> <p align=""justify"">An ICS/LABA includes budesonide/formoterol, fluticasone/salmeterol, or fluticasone/vilanterol</p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7794_5509_R","Long-term maintenance treatment","RESTRICTED","5509","7794","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease</p><br/><p>Long-term maintenance treatment</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease</p><br/><p>Long-term maintenance treatment</p> <p align=""justify"">The treatment must not be used in combination with a LAMA/LABA or SAMA</p> <p align=""justify"">A LAMA/LABA includes aclidinium/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, or umeclidinium/vilanterol.</p> <p align=""justify"">A SAMA includes ipratropium</p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7800_7822_R","null","STREAMLINED","7822","7800","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must be at greater than 20% risk of developing febrile neutropenia; or</p> <p>Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must be at greater than 20% risk of developing febrile neutropenia; or</p> <p>Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7801_6925_R","null","STREAMLINED","6925","7801","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity of cerebral origin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity of cerebral origin.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7804_4516_R","null","RESTRICTED","4516","7804","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p> <p align=""justify"">The treatment must not be used in combination with a LAMA/LABA or SAMA</p> <p align=""justify"">A LAMA/LABA includes aclidinium/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, or umeclidinium/vilanterol.</p> <p align=""justify"">A SAMA includes ipratropium</p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7805_6825_R","null","RESTRICTED","6825","7805","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.</p> <p align=""justify"">Pharmaceutical benefits that have a 30 x 2 pack size and a 20 x 3 pack size are equivalent for the purposes of substitution<b><i>.</i></b></p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7809_4998_R","Continuing treatment","STREAMLINED","4998","7809","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a psychiatrist; or</p> <p>Must be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; AND</p> <p>Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND</p> <p>Patient must have completed at least 18 weeks therapy; AND</p> <p>Patient must be on a clozapine dosage considered stable by a treating psychiatrist; AND</p> <p>The treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.</p> <p align=""justify"">A medical practitioner should request a quantity sufficient for up to one month&apos;s supply. Up to 5 repeats will be authorised. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a psychiatrist; or</p> <p>Must be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; AND</p> <p>Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND</p> <p>Patient must have completed at least 18 weeks therapy; AND</p> <p>Patient must be on a clozapine dosage considered stable by a treating psychiatrist; AND</p> <p>The treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.</p> <p align=""justify"">A medical practitioner should request a quantity sufficient for up to one month&apos;s supply. Up to 5 repeats will be authorised. </p> <p align=""justify"">Patients receiving clozapine under the PBS listing must be registered in the clozapine patient monitoring program relevant for the brand of clozapine being prescribed and dispensed: Pfizer ClopineCentral.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7812_6939_R","null","STREAMLINED","6939","7812","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to multiple sclerosis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to multiple sclerosis.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7813_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms omeprazole tablet 20 mg, omeprazole capsule 20 mg and omeprazole tablet 20 mg (as magnesium) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2012-10-01","N","4708"
"7828_5015_R","Initial treatment","STREAMLINED","5015","7828","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Initial treatment</p><br/><p>Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient; AND</p> <p>Patient must be non-responsive to other neuroleptic agents; or</p> <p>Patient must be intolerant of other neuroleptic agents.</p> <p align=""justify"">Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.</p> <p>The name of the consulting psychiatrist should be included in the patient&apos;s medical records.</p> <p align=""justify"">A medical practitioner should request a quantity sufficient for up to one month&apos;s supply. Up to 5 repeats will be authorised. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Initial treatment</p><br/><p>Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient; AND</p> <p>Patient must be non-responsive to other neuroleptic agents; or</p> <p>Patient must be intolerant of other neuroleptic agents.</p> <p align=""justify"">Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.</p> <p>The name of the consulting psychiatrist should be included in the patient&apos;s medical records.</p> <p align=""justify"">A medical practitioner should request a quantity sufficient for up to one month&apos;s supply. Up to 5 repeats will be authorised. </p> <p align=""justify"">Patients receiving clozapine under the PBS listing must be registered in the clozapine patient monitoring program relevant for the brand of clozapine being prescribed and dispensed: Pfizer ClopineCentral.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7830_6911_R","null","STREAMLINED","6911","7830","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord disease.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7833_4930_R","null","STREAMLINED","4930","7833","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 4 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 4 years or older.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7839_6352_R","null","RESTRICTED","6352","7839","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p> <p align=""justify"">The treatment must not be used in combination with a LAMA/LABA or SAMA</p> <p align=""justify"">A LAMA/LABA includes aclidinium/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, or umeclidinium/vilanterol.</p> <p align=""justify"">A SAMA includes ipratropium</p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7840_6341_R","null","RESTRICTED","6341","7840","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic obstructive pulmonary disease (COPD)</p><br/><p>Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer.</p> <p align=""justify"">Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7843_7843_R","null","STREAMLINED","7843","7843","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must have had a prior episode of febrile neutropenia; or</p> <p>Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must have had a prior episode of febrile neutropenia; or</p> <p>Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7850_4930_R","null","STREAMLINED","4930","7850","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 4 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 4 years or older.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7850_N","null","null","null","null","null","<p align=""justify"">Molnlycke Health Care products are distributed through leading pharmacy distributors. To best ensure product availability at the RPBS agreed prices, special arrangements have been made with API and Independence Australia Health Solutions (IAHS). IAHS orders can be placed on: Tel: 1300 788 855; or Email: <u>customerservice@independenceaustralia.com</u>. Molnlycke Health Care is not able to ensure product availability or pricing on listed products beyond these two suppliers.</p>","Y","N","N","null","null","N","2012-12-01","N","4708"
"7855_7781_R","Prevention of condition","STREAMLINED","7781","7855","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Prevention of condition</p><br/><p>The condition must be exercise-induced; AND</p> <p>The treatment must be as an alternative to adding salmeterol xinafoate; or</p> <p>The treatment must be an alternative to adding formoterol fumarate; AND</p> <p>The condition must be otherwise well controlled while receiving optimal dose inhaled corticosteroid; AND</p> <p>Patient must require short-acting beta-2 agonist 3 or more times per week for prevention or relief of residual exercise-related symptoms; AND</p> <p>Patient must be aged 6 to 14 years inclusive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Prevention of condition</p><br/><p>The condition must be exercise-induced; AND</p> <p>The treatment must be as an alternative to adding salmeterol xinafoate; or</p> <p>The treatment must be an alternative to adding formoterol fumarate; AND</p> <p>The condition must be otherwise well controlled while receiving optimal dose inhaled corticosteroid; AND</p> <p>Patient must require short-acting beta-2 agonist 3 or more times per week for prevention or relief of residual exercise-related symptoms; AND</p> <p>Patient must be aged 6 to 14 years inclusive.</p> <p align=""justify"">This drug is not PBS-subsidised for use in a patient aged 15 years or older, or for use in addition to a long-acting beta-agonist in any age group, or for use as a single second line preventer, as an alternative to corticosteroids, in a child aged 6 to 14 years with moderate to severe asthma.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7856_4404_R","null","STREAMLINED","4404","7856","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">Unlike Symbicort Turbuhaler 200/6, Symbicort Rapihaler 200/6 is not recommended nor PBS-subsidised for use as &apos;maintenance and reliever&apos; therapy as the approved Product Information does not specify such use.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7857_4380_R","null","STREAMLINED","4380","7857","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7863_4731_R","null","STREAMLINED","4731","7863","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p> <p align=""justify"">This drug is not recommended nor PBS-subsidised for use as &apos;maintenance and reliever&apos; therapy.</p> <p align=""justify"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-08-01","N","4708"
"7909_6172_R","null","STREAMLINED","6172","7909","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe dry eye syndrome</p><br/><p>Patient must be sensitive to preservatives in multi-dose eye drops.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe dry eye syndrome</p><br/><p>Patient must be sensitive to preservatives in multi-dose eye drops.</p> <p align=""justify"">The in-use shelf life of Novatears is 6 months from the date of opening.</p>","N","N","N","IMMEDIATE","ALL","N","2018-09-01","N","4708"
"7971_7943_R","Induction treatment","STREAMLINED","7943","7971","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Previously untreated stage II bulky or stage III or IV indolent non-Hodgkin''s lymphoma</p><br/><p>Induction treatment</p><br/><p>The condition must be CD20 positive; AND</p> <p>The condition must be previously untreated; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for induction treatment purposes only; AND</p> <p>The treatment must be in combination with rituximab or obinutuzumab; AND</p> <p>The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Previously untreated stage II bulky or stage III or IV indolent non-Hodgkin''s lymphoma</p><br/><p>Induction treatment</p><br/><p>The condition must be CD20 positive; AND</p> <p>The condition must be previously untreated; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for induction treatment purposes only; AND</p> <p>The treatment must be in combination with rituximab or obinutuzumab; AND</p> <p>The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2018-10-01","N","4708"
"7973_7944_R","Re-induction treatment","STREAMLINED","7944","7973","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Follicular lymphoma</p><br/><p>Re-induction treatment</p><br/><p>The condition must be CD20 positive; AND</p> <p>The condition must be refractory to treatment with rituximab for this condition; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for re-induction treatment purposes only; AND</p> <p>The treatment must be in combination with obinutuzumab; AND</p> <p>The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction.</p> <p align=""justify"">The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Follicular lymphoma</p><br/><p>Re-induction treatment</p><br/><p>The condition must be CD20 positive; AND</p> <p>The condition must be refractory to treatment with rituximab for this condition; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for re-induction treatment purposes only; AND</p> <p>The treatment must be in combination with obinutuzumab; AND</p> <p>The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction.</p> <p align=""justify"">The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2018-10-01","N","4708"
"7980_7972_R","Induction treatment","STREAMLINED","7972","7980","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Previously untreated stage III or IV mantle cell lymphoma</p><br/><p>Induction treatment</p><br/><p>The condition must be CD20 positive; AND</p> <p>The treatment must be in combination with rituximab; AND</p> <p>The condition must be previously untreated; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for induction treatment purposes only; AND</p> <p>Patient must not receive more than 6 cycles (12 doses) of treatment under this restriction; AND</p> <p>Patient must not be eligible for stem cell transplantation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Previously untreated stage III or IV mantle cell lymphoma</p><br/><p>Induction treatment</p><br/><p>The condition must be CD20 positive; AND</p> <p>The treatment must be in combination with rituximab; AND</p> <p>The condition must be previously untreated; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for induction treatment purposes only; AND</p> <p>Patient must not receive more than 6 cycles (12 doses) of treatment under this restriction; AND</p> <p>Patient must not be eligible for stem cell transplantation.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2018-10-01","N","4708"
"7988_7970_R","null","STREAMLINED","7970","7988","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; or</p> <p>Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.</p> <p align=""justify"">This product is not indicated for the initiation of treatment in asthma</p> <p align=""justify"">This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align=""justify"">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align=""justify"">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2018-10-01","N","4708"
"8149_8165_R","null","STREAMLINED","8165","8149","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>The condition must be active; AND</p> <p>Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND</p> <p>The treatment must be after failure of other therapy including dopamine agonists; or</p> <p>The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or</p> <p>The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.</p> <p align=""justify"">In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>The condition must be active; AND</p> <p>Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND</p> <p>The treatment must be after failure of other therapy including dopamine agonists; or</p> <p>The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or</p> <p>The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.</p> <p align=""justify"">In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission </p>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8159_8161_R","null","STREAMLINED","8161","8159","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>The condition must be controlled with octreotide immediate release injections; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.</p> <p align=""justify"">In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>The condition must be controlled with octreotide immediate release injections; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.</p> <p align=""justify"">In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission </p>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8162_8208_R","null","STREAMLINED","8208","8162","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved symptom control on octreotide immediate release injections; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved symptom control on octreotide immediate release injections; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8163_8198_R","null","STREAMLINED","8198","8163","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vasoactive intestinal peptide secreting tumour (VIPoma)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved symptom control on octreotide immediate release injections; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vasoactive intestinal peptide secreting tumour (VIPoma)</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have achieved symptom control on octreotide immediate release injections; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8164_8197_R","null","STREAMLINED","8197","8164","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be controlled with octreotide immediate release injections; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.</p> <p align=""justify"">In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The condition must be controlled with octreotide immediate release injections; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.</p> <p align=""justify"">In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission </p>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8194_8183_R","Continuing treatment","STREAMLINED","8183","8194","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic colorectal cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8211_C","null","null","null","null","null","<p align=""justify"">The risk of drug dependence is high.</p>","N","Y","N","null","null","N","2013-02-03","N","4708"
"8214_8214_R","Initial treatment","STREAMLINED","8214","8214","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Patient must be virologically suppressed on a stable antiretroviral regimen for at least 6 months; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Patient must be virologically suppressed on a stable antiretroviral regimen for at least 6 months; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8221_N","null","null","null","null","null","<p align=""justify"">For immunisation of adults and children aged greater than or equal to 8 years.</p>","Y","N","N","null","null","N","2015-04-01","N","4708"
"8226_8226_R","Continuing treatment","STREAMLINED","8226","8226","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8235_7375_R","Initial treatment","AUTHORITY_REQUIRED","7375","8235","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Initial treatment</p><br/><p>Patient must be transfusion dependent; AND</p> <p>Patient must not have a malignant disorder of erythropoiesis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Initial treatment</p><br/><p>Patient must be transfusion dependent; AND</p> <p>Patient must not have a malignant disorder of erythropoiesis.</p>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8236_7374_R","Initial treatment","AUTHORITY_REQUIRED","7374","8236","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Initial treatment</p><br/><p>Patient must not be transfusion dependent; AND</p> <p>The condition must be thalassaemia.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Initial treatment</p><br/><p>Patient must not be transfusion dependent; AND</p> <p>The condition must be thalassaemia.</p>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8239_7385_R","Initial treatment","AUTHORITY_REQUIRED","7385","8239","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Initial treatment</p><br/><p>Patient must be red blood cell transfusion dependent; AND</p> <p>Patient must have a serum ferritin level of greater than 1000 microgram/L; AND</p> <p>Patient must have a malignant disorder of haemopoiesis; AND</p> <p>Patient must have a median life expectancy exceeding five years.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Initial treatment</p><br/><p>Patient must be red blood cell transfusion dependent; AND</p> <p>Patient must have a serum ferritin level of greater than 1000 microgram/L; AND</p> <p>Patient must have a malignant disorder of haemopoiesis; AND</p> <p>Patient must have a median life expectancy exceeding five years.</p> <p/><p align=""justify"">A patient&apos;s median life expectancy is determined by the severity of their underlying disease. </p><p/> <p/><p align=""justify""> Patients with underlying myelodysplastic syndrome are considered to have a median life expectancy exceeding five years if they are classified as:</p><p/><p align=""justify"">- low risk according to the International Prognostic Scoring System (IPSS); or</p><p/><p align=""justify"">- very low and low risk according to the Revised International Prognostic Scoring System (IPSS-R); or</p><p/><p align=""justify""> - very low and low risk according to the WHO classification based Prognostic Scoring System (WPSS). </p><p/> <p/><p align=""justify"">Patients with underlying myelofibrosis have a median life expectancy exceeding five years if they are classified as: </p><p/><p align=""justify""> - low or intermediate risk according to the International Prognostic Scoring System (IPSS); or</p><p/><p align=""justify""> - low or intermediate-1 risk according to Dynamic International Prognostic Scoring System (DIPSS). </p><p/>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8241_4649_R","null","STREAMLINED","4649","8241","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Patient must have progressive disease; AND</p> <p>Patient must have failed at least two prior chemotherapeutic regimens for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>Patient must have progressive disease; AND</p> <p>Patient must have failed at least two prior chemotherapeutic regimens for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">A patient who has progressive disease with eribulin is no longer eligible for PBS-subsidised eribulin.</p>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8253_7258_R","Initial treatment","STREAMLINED","7258","8253","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) liposarcoma</p><br/><p>Initial treatment</p><br/><p>Patient must have an ECOG performance status of 2 or less; AND</p> <p>The condition must be dedifferentiated, myxoid, round-cell or pleomorphic subtype; AND</p> <p>Patient must have received prior chemotherapy treatment including an anthracycline and ifosfamide (unless contraindicated) for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be aged 18 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) liposarcoma</p><br/><p>Initial treatment</p><br/><p>Patient must have an ECOG performance status of 2 or less; AND</p> <p>The condition must be dedifferentiated, myxoid, round-cell or pleomorphic subtype; AND</p> <p>Patient must have received prior chemotherapy treatment including an anthracycline and ifosfamide (unless contraindicated) for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be aged 18 years or older.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8258_7280_R","Continuing treatment","STREAMLINED","7280","8258","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) liposarcoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop progressive disease while being treated with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be aged 18 years or older.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) liposarcoma</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not develop progressive disease while being treated with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>Patient must be aged 18 years or older.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2018-12-01","N","4708"
"8286_C","null","null","null","null","null","<p>Use of ACE inhibitors during pregnancy is contraindicated since these drugs have been associated with foetal death in utero.</p>","N","Y","N","null","null","N","2013-04-01","N","4708"
"8295_N","null","null","null","null","null","<p>Pharmaceutical benefits that have the form perindopril with indapamide hemihydrate tablet (containing 4 mg perindopril erbumine-1.25 mg indapamide hemihydrate) and pharmaceutical benefits that have the form perindopril with indapamide hemihydrate tablet (containing 5 mg perindopril arginine-1.25 mg indapamide hemihydrate) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2013-04-01","N","4708"
"8298_8288_R","Continuing treatment","STREAMLINED","8288","8298","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Autosomal dominant polycystic kidney disease (ADPKD)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a nephrologist or in consultation with a nephrologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have end-stage renal disease defined as an estimated glomerular filtration rate (eGFR) of less than 15 mL/min/1.73m2; AND</p> <p>Patient must not have had a kidney transplant.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Autosomal dominant polycystic kidney disease (ADPKD)</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a nephrologist or in consultation with a nephrologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have end-stage renal disease defined as an estimated glomerular filtration rate (eGFR) of less than 15 mL/min/1.73m2; AND</p> <p>Patient must not have had a kidney transplant.</p>","N","N","N","IMMEDIATE","ALL","N","2019-01-01","N","4708"
"8299_C","null","null","null","null","null","<p>The myocardial depressant effects of verapamil hydrochloride and of beta-blocking drugs are additive.</p>","N","Y","N","null","null","N","2013-04-01","N","4708"
"8327_8326_R","Continuing treatment","STREAMLINED","8326","8327","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Continuing treatment</p><br/><p>Patient must be red blood cell transfusion dependent; AND</p> <p>Patient must have a malignant disorder of haemopoieisis; AND</p> <p>Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Continuing treatment</p><br/><p>Patient must be red blood cell transfusion dependent; AND</p> <p>Patient must have a malignant disorder of haemopoieisis; AND</p> <p>Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.</p> <p align=""justify"">Interruption of treatment should be considered if serum ferritin levels fall consistently below 500 microgram/mL.</p>","N","N","N","IMMEDIATE","ALL","N","2019-02-01","N","4708"
"8332_8328_R","Continuing treatment","STREAMLINED","8328","8332","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Continuing treatment</p><br/><p>Patient must be transfusion dependent; AND</p> <p>Patient must not have a malignant disorder of erythropoiesis; AND</p> <p>Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Continuing treatment</p><br/><p>Patient must be transfusion dependent; AND</p> <p>Patient must not have a malignant disorder of erythropoiesis; AND</p> <p>Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2019-02-01","N","4708"
"8478_8329_R","Continuing treatment","STREAMLINED","8329","8478","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Continuing treatment</p><br/><p>Patient must not be transfusion dependent; AND</p> <p>The condition must be thalassaemia; AND</p> <p>Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Continuing treatment</p><br/><p>Patient must not be transfusion dependent; AND</p> <p>The condition must be thalassaemia; AND</p> <p>Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2019-02-01","N","4708"
"8541_N","null","null","null","null","null","<p align=""left"">Smith &amp; Nephew products are distributed via the three major wholesalers, API, Sigma and Symbion. To best ensure product availability at RPBS agreed prices, please order from one of these suppliers. In the event that your preferred wholesaler cannot supply, please contact Smith &amp; Nephew Customer Service on 13 13 60. Smith &amp; Nephew cannot ensure RPBS agreed pricing from distributors other than those aforementioned.</p>","Y","N","N","null","null","N","2013-04-03","N","4708"
"8544_8544_R","Initial treatment","STREAMLINED","8544","8544","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Initial treatment</p><br/><p>Must be treated by a paediatrician or psychiatrist; AND</p> <p>The condition must be or have been diagnosed according to the DSM-5 criteria; AND</p> <p>Patient must be receiving a maximum tolerated dose (MTD) of stimulant (dexamfetamine, methylphenidate or lisdexamfetamine) which has been stable for at least four weeks; AND</p> <p>The treatment must be adjunctive to ongoing maximum tolerated dose (MTD) of stimulant (dexamfetamine, methylphenidate or lisdexamfetamine); AND</p> <p>Patient must be experiencing residual moderate to severe ADHD symptoms resulting in impaired functioning (social, academic or occupational), present in at least one setting (home, nursery/school/college/work, friends or family homes or other environment); AND</p> <p>Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Initial treatment</p><br/><p>Must be treated by a paediatrician or psychiatrist; AND</p> <p>The condition must be or have been diagnosed according to the DSM-5 criteria; AND</p> <p>Patient must be receiving a maximum tolerated dose (MTD) of stimulant (dexamfetamine, methylphenidate or lisdexamfetamine) which has been stable for at least four weeks; AND</p> <p>The treatment must be adjunctive to ongoing maximum tolerated dose (MTD) of stimulant (dexamfetamine, methylphenidate or lisdexamfetamine); AND</p> <p>Patient must be experiencing residual moderate to severe ADHD symptoms resulting in impaired functioning (social, academic or occupational), present in at least one setting (home, nursery/school/college/work, friends or family homes or other environment); AND</p> <p>Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive.</p>","N","N","N","IMMEDIATE","ALL","N","2019-03-01","N","4708"
"8554_8621_R","Initial treatment","AUTHORITY_REQUIRED","8621","8554","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised treatment with this drug.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised treatment with this drug.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2019-03-01","N","4708"
"8559_N","null","null","null","null","null","<p align=""justify""><i>Helicobacter pylori</i> eradication therapy should be considered prior to commencing initial treatment of peptic ulcer with this drug.</p>","Y","N","N","null","null","N","2013-06-01","N","4708"
"8579_N","null","null","null","null","null","<p align=""justify"">Used as an adjunct in the management of leg ulceration and associated eczema and skin conditions.</p>","Y","N","N","null","null","N","2013-07-01","N","4708"
"8580_N","null","null","null","null","null","<p align=""justify"">Treatment of varices and oedema associated with venous disease and lymphoedema; contraindicated in arterial disease.</p>","Y","N","N","null","null","N","2013-07-01","N","4708"
"8582_8622_R","Initial treatment","AUTHORITY_REQUIRED","8622","8582","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised everolimus.</p> <p align=""justify"">Patients who have progressive disease with everolimus are no longer eligible for PBS-subsidised everolimus.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised everolimus.</p> <p align=""justify"">Patients who have progressive disease with everolimus are no longer eligible for PBS-subsidised everolimus.</p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p>","N","N","N","IMMEDIATE","ALL","N","2019-03-01","N","4708"
"8582_N","null","null","null","null","null","<p align=""justify"">Sorafenib is not PBS-subsidised for adjunctive treatment after resection, ablation or chemoembolization.</p><p align=""justify"">Sorafenib is not PBS-subsidised for maintenance therapy after disease progression.</p>","Y","N","N","null","null","N","2013-07-01","N","4708"
"8585_8585_R","Continuing treatment","STREAMLINED","8585","8585","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be adjunctive to ongoing maximum tolerated dose (MTD) of stimulant (dexamfetamine, methylphenidate or lisdexamfetamine).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be adjunctive to ongoing maximum tolerated dose (MTD) of stimulant (dexamfetamine, methylphenidate or lisdexamfetamine).</p>","N","N","N","IMMEDIATE","ALL","N","2019-03-01","N","4708"
"8590_N","null","null","null","null","null","<p align=""justify"">The patient or carer must be able to understand and administer the imiquimod dosing regimen.</p>","Y","N","N","null","null","N","2013-07-01","N","4708"
"8591_N","null","null","null","null","null","<p align=""justify"">Treatment of recurrent (previously treated) lesions will not be authorised.</p>","Y","N","N","null","null","N","2013-07-01","N","4708"
"8592_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form imiquimod single use sachets and pharmaceutical benefits that have the form imiquimod multi-use pump are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2013-07-01","N","4708"
"8598_8588_R","Initial treatment","AUTHORITY_REQUIRED","8588","8598","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised treatment with this drug.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Prescribers may request an increased maximum quantity sufficient to provide up to one month&apos;s supply for patients who require dose adjustment. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised treatment with this drug.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align=""justify"">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align=""justify"">Complete response (CR) is disappearance of all target lesions.</p><p align=""justify"">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align=""justify"">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align=""justify"">Stable disease (SD) is small changes that do not meet above criteria.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">Prescribers may request an increased maximum quantity sufficient to provide up to one month&apos;s supply for patients who require dose adjustment. </p>","N","N","N","IMMEDIATE","ALL","Y","2019-03-01","N","4708"
"8606_8606_R","null","STREAMLINED","8606","8606","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>Must be treated by a respiratory physician, paediatric respiratory physician, clinical immunologist, allergist, paediatrician or general physician experienced in the management of patients with severe asthma; or in consultation with one of these specialists; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND</p> <p>Patient must have experienced at least one severe exacerbation prior to receiving PBS-subsidised treatment with this drug for this condition, which has required documented use of systemic corticosteroids in the previous 12 months while receiving optimised asthma therapy; or</p> <p>Patient must have experienced frequent episodes of moderate asthma exacerbations prior to receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of a medium to high dose ICS and a LABA. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe asthma</p><br/><p>Must be treated by a respiratory physician, paediatric respiratory physician, clinical immunologist, allergist, paediatrician or general physician experienced in the management of patients with severe asthma; or in consultation with one of these specialists; AND</p> <p>Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND</p> <p>Patient must have experienced at least one severe exacerbation prior to receiving PBS-subsidised treatment with this drug for this condition, which has required documented use of systemic corticosteroids in the previous 12 months while receiving optimised asthma therapy; or</p> <p>Patient must have experienced frequent episodes of moderate asthma exacerbations prior to receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta-2 agonist (LABA) unless a LABA is contraindicated; AND</p> <p>Patient must be aged 6 to 17 years inclusive.</p> <p align=""justify"">Optimised asthma therapy includes adherence to the maintenance combination of a medium to high dose ICS and a LABA. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative</p> <p align=""justify"">Formal assessment and correction of inhaler technique should be performed in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique (available at www.humanservices.gov.au or www.nationalasthma.org.au); the assessment and adherence to correct technique should be documented in the patient&apos;s medical records. Patients can obtain support with inhaler technique through their local Asthma Foundation (1800 645 130).</p> <p align=""justify"">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before &quot;stepping up&quot; a patient&apos;s medication regimen.</p>","N","N","N","IMMEDIATE","ALL","N","2019-03-01","N","4708"
"8624_8624_R","null","RESTRICTED","8624","8624","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.</p>","N","N","N","IMMEDIATE","ALL","N","2019-04-01","N","4708"
"8667_8667_R","null","STREAMLINED","8667","8667","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must have had a prior episode of febrile neutropenia; or</p> <p>Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must have had a prior episode of febrile neutropenia; or</p> <p>Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.</p>","N","N","N","IMMEDIATE","ALL","N","2019-04-01","N","4708"
"8668_8668_R","null","STREAMLINED","8668","8668","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mobilisation of peripheral blood progenitor cells</p><br/><p>The treatment must be in a normal volunteer for use in allogeneic transplantation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mobilisation of peripheral blood progenitor cells</p><br/><p>The treatment must be in a normal volunteer for use in allogeneic transplantation.</p>","N","N","N","IMMEDIATE","ALL","N","2019-04-01","N","4708"
"8669_8669_R","null","STREAMLINED","8669","8669","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe congenital neutropenia</p><br/><p>Patient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; AND</p> <p>Patient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe congenital neutropenia</p><br/><p>Patient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; AND</p> <p>Patient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.</p>","N","N","N","IMMEDIATE","ALL","N","2019-04-01","N","4708"
"8670_8670_R","null","STREAMLINED","8670","8670","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic neutropenia</p><br/><p>Patient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; or</p> <p>Patient must have neutrophil dysfunction; AND</p> <p>Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; or</p> <p>Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic neutropenia</p><br/><p>Patient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; or</p> <p>Patient must have neutrophil dysfunction; AND</p> <p>Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; or</p> <p>Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.</p>","N","N","N","IMMEDIATE","ALL","N","2019-04-01","N","4708"
"8671_8671_R","null","STREAMLINED","8671","8671","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisting bone marrow transplantation</p><br/><p>Patient must be receiving marrow-ablative chemotherapy prior to the transplantation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisting bone marrow transplantation</p><br/><p>Patient must be receiving marrow-ablative chemotherapy prior to the transplantation.</p>","N","N","N","IMMEDIATE","ALL","N","2019-04-01","N","4708"
"8672_8672_R","null","STREAMLINED","8672","8672","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mobilisation of peripheral blood progenitor cells</p><br/><p>The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mobilisation of peripheral blood progenitor cells</p><br/><p>The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2019-04-01","N","4708"
"8673_8673_R","null","STREAMLINED","8673","8673","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic cyclical neutropenia</p><br/><p>Patient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles; AND</p> <p>Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; or</p> <p>Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic cyclical neutropenia</p><br/><p>Patient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles; AND</p> <p>Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; or</p> <p>Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.</p>","N","N","N","IMMEDIATE","ALL","N","2019-04-01","N","4708"
"8674_8674_R","null","STREAMLINED","8674","8674","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must be at greater than 20% risk of developing febrile neutropenia; or</p> <p>Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must be at greater than 20% risk of developing febrile neutropenia; or</p> <p>Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.</p>","N","N","N","IMMEDIATE","ALL","N","2019-04-01","N","4708"
"8695_8734_R","Initial sole PBS-subsidised supply for anticipated emergency treatment","AUTHORITY_REQUIRED","8734","8695","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute allergic reaction with anaphylaxis</p><br/><p>Initial sole PBS-subsidised supply for anticipated emergency treatment</p><br/><p>Patient must have been discharged from hospital or an emergency department after treatment with adrenaline (epinephrine) for acute allergic reaction with anaphylaxis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute allergic reaction with anaphylaxis</p><br/><p>Initial sole PBS-subsidised supply for anticipated emergency treatment</p><br/><p>Patient must have been discharged from hospital or an emergency department after treatment with adrenaline (epinephrine) for acute allergic reaction with anaphylaxis.</p>","N","N","N","IMMEDIATE","ALL","N","2019-04-01","N","4708"
"8696_8696_R","null","STREAMLINED","8696","8696","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisting autologous peripheral blood progenitor cell transplantation</p><br/><p>The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Assisting autologous peripheral blood progenitor cell transplantation</p><br/><p>The treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.</p>","N","N","N","IMMEDIATE","ALL","N","2019-04-01","N","4708"
"8757_N","null","null","null","null","null","<p align=""justify"">For first continuing supply, applications for increased repeats for up to 3 months&apos; supply may be authorised.</p>","Y","N","N","null","null","N","2013-08-01","N","4708"
"8758_N","null","null","null","null","null","<p align=""justify"">Where consultation with a palliative care specialist or service has occurred, applications for increased repeats for up to 3 months&apos; supply may be authorised.</p>","Y","N","N","null","null","N","2013-08-01","N","4708"
"8759_N","null","null","null","null","null","<p align=""justify"">Telephone approvals are limited to 1 months&apos; therapy.</p>","Y","N","N","null","null","N","2013-08-01","N","4708"
"8773_8774_R","null","STREAMLINED","8774","8773","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastro-oesophageal reflux disease</p><br/><p>The treatment must be for initial treatment of symptomatic gastro-oesophageal reflux disease; or</p> <p>The treatment must be for the short-term maintenance treatment of gastro-oesophageal reflux disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastro-oesophageal reflux disease</p><br/><p>The treatment must be for initial treatment of symptomatic gastro-oesophageal reflux disease; or</p> <p>The treatment must be for the short-term maintenance treatment of gastro-oesophageal reflux disease.</p>","N","N","N","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"8781_8780_R","null","STREAMLINED","8780","8781","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Scleroderma oesophagus</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Scleroderma oesophagus</p>","N","N","N","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"8788_8831_R","Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","8831","8788","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">Authority approval for sufficient therapy to complete a maximum of 16 weeks of treatment may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"8821_5178_R","null","STREAMLINED","5178","8821","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe spasticity of the upper limb</p><br/><p>Patient must have cerebral palsy; AND</p> <p>Patient must be aged from 2 to 17 years inclusive; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a plastic surgeon.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe spasticity of the upper limb</p><br/><p>Patient must have cerebral palsy; AND</p> <p>Patient must be aged from 2 to 17 years inclusive; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a plastic surgeon.</p>","N","N","N","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"8823_8775_R","Initial treatment","STREAMLINED","8775","8823","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Peptic ulcer</p><br/><p>Initial treatment</p><br/><p>Patient must have tested negative for helicobacter pylori infection; or</p> <p>Patient must have failed treatment with helicobacter pylori eradication therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Peptic ulcer</p><br/><p>Initial treatment</p><br/><p>Patient must have tested negative for helicobacter pylori infection; or</p> <p>Patient must have failed treatment with helicobacter pylori eradication therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"8824_8776_R","null","STREAMLINED","8776","8824","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastro-oesophageal reflux disease</p><br/><p>The treatment must be for long-term maintenance of gastro-oesophageal reflux disease in a patient with symptoms inadequately controlled using a low dose proton pump inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastro-oesophageal reflux disease</p><br/><p>The treatment must be for long-term maintenance of gastro-oesophageal reflux disease in a patient with symptoms inadequately controlled using a low dose proton pump inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"8826_8902_R","null","AUTHORITY_REQUIRED","8902","8826","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastro-oesophageal reflux disease</p><br/><p>Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastro-oesophageal reflux disease</p><br/><p>Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor.</p>","N","N","N","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"8843_8940_R","Subsequent continuing treatment, Face, hand, foot","STREAMLINED","8940","8843","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"8865_8866_R","null","STREAMLINED","8866","8865","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Zollinger-Ellison syndrome</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Zollinger-Ellison syndrome</p>","N","N","N","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"8901_5359_R","null","STREAMLINED","5359","8901","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dynamic equinus foot deformity</p><br/><p>The condition must be due to spasticity; AND</p> <p>Patient must have cerebral palsy; AND</p> <p>Patient must be ambulant; AND</p> <p>Patient must be aged from 2 to 17 years inclusive; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a rehabilitation specialist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dynamic equinus foot deformity</p><br/><p>The condition must be due to spasticity; AND</p> <p>Patient must have cerebral palsy; AND</p> <p>Patient must be ambulant; AND</p> <p>Patient must be aged from 2 to 17 years inclusive; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a rehabilitation specialist.</p>","N","N","N","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"8928_8929_R","null","STREAMLINED","8929","8928","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe spasticity of the upper limb</p><br/><p>Patient must have cerebral palsy; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a plastic surgeon.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe spasticity of the upper limb</p><br/><p>Patient must have cerebral palsy; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a plastic surgeon.</p>","N","N","N","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"8930_8822_R","null","STREAMLINED","8822","8930","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dynamic equinus foot deformity</p><br/><p>The condition must be due to spasticity; AND</p> <p>Patient must have cerebral palsy; AND</p> <p>Patient must be ambulant; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a rehabilitation specialist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Dynamic equinus foot deformity</p><br/><p>The condition must be due to spasticity; AND</p> <p>Patient must have cerebral palsy; AND</p> <p>Patient must be ambulant; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a rehabilitation specialist.</p>","N","N","N","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"8950_8827_R","null","STREAMLINED","8827","8950","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion</p>","N","N","N","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"9001_8844_R","Subsequent continuing treatment, Whole body","STREAMLINED","8844","9001","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2019-05-01","N","4708"
"9031_9031_R","Continuing treatment","STREAMLINED","9031","9031","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; or</p> <p>Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; or</p> <p>Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; or</p> <p>Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously).</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; or</p> <p>Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; or</p> <p>Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; or</p> <p>Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously).</p>","N","N","N","IMMEDIATE","ALL","N","2019-06-01","N","4708"
"9036_9034_R","Initial treatment","STREAMLINED","9034","9036","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Initial treatment</p><br/><p>Must be treated by a paediatrician or psychiatrist; AND</p> <p>The condition must be or have been diagnosed according to the DSM-5 criteria; AND</p> <p>Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; or</p> <p>Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; or</p> <p>Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; or</p> <p>Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously); AND</p> <p>Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Attention deficit hyperactivity disorder</p><br/><p>Initial treatment</p><br/><p>Must be treated by a paediatrician or psychiatrist; AND</p> <p>The condition must be or have been diagnosed according to the DSM-5 criteria; AND</p> <p>Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; or</p> <p>Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; or</p> <p>Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; or</p> <p>Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously); AND</p> <p>Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive.</p>","N","N","N","IMMEDIATE","ALL","N","2019-06-01","N","4708"
"9038_7087_R","Continuing treatment","AUTHORITY_REQUIRED","7087","9038","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be given concomitantly with a PBS-subsidised somatostatin analogue; AND</p> <p>The treatment must cease if IGF-1 is not lower after 3 months of pegvisomant treatment at the maximum tolerated dose.</p> <p align=""justify"">Somatostatin analogues include octreotide, lanreotide and pasireotide</p> <p align=""justify"">In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission.</p> <p align=""justify"">Biochemical evidence of remission is defined as normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1).</p> <p align=""justify"">In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; and a copy of IGF-1 level taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of application.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be given concomitantly with a PBS-subsidised somatostatin analogue; AND</p> <p>The treatment must cease if IGF-1 is not lower after 3 months of pegvisomant treatment at the maximum tolerated dose.</p> <p align=""justify"">Somatostatin analogues include octreotide, lanreotide and pasireotide</p> <p align=""justify"">In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission.</p> <p align=""justify"">Biochemical evidence of remission is defined as normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1).</p> <p align=""justify"">In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; and a copy of IGF-1 level taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of application.</p> <p align=""justify"">Applications for authorisation under this criterion may be made by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2019-07-01","N","4708"
"9040_9041_R","Initial treatment","AUTHORITY_REQUIRED","9041","9040","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>Initial treatment</p><br/><p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have an age- and sex-adjusted insulin-like growth factor 1 (IGF-1) concentration greater than the upper limit of normal (ULN); AND</p> <p>The treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information; AND</p> <p>The treatment must not be given concomitantly with a PBS-subsidised somatostatin analogue.</p> <p align=""justify"">Somatostatin analogues include octreotide, lanreotide and pasireotide</p> <p align=""justify"">Failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide is defined as:</p><p align=""justify"">1) Growth hormone level greater than 1 mcg/L or 3 mIU/L; OR</p><p align=""justify"">2) IGF-1 level is greater than the age- and sex-adjusted ULN.</p> <p align=""justify"">If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of contraindication.</p> <p align=""justify"">If intolerance to either octreotide or lanreotide treatment developed during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission.</p> <p align=""justify"">Biochemical evidence of remission is defined as normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1).</p> <p align=""justify"">Two completed authority prescriptions should be submitted with the initial application for this drug. One prescription should be for the loading dose of 80 mg for a quantity of 4 vials of 20 mg with no repeats. The second prescription should be for subsequent doses, starting from 10 mg daily, and allowing dose adjustments in increments of 5 mg based on serum IGF-1 levels measured every 4 to 6 weeks in order to maintain the serum IGF-1 level within the age-adjusted normal range based on the dosage recommendations in the TGA-approved Product Information.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">a) two completed authority prescription forms ; and</p><p align=""justify"">b) a completed Acromegaly Pegvisomant initial PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">c) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy, the date and result of IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy; and</p><p align=""justify"">d) a recent result of the IGF-1 level and the date of assessment ; and</p><p align=""justify"">e) demonstration of failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">No increase in the maximum quantity or number of units may be authorised for the loading dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>Initial treatment</p><br/><p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have an age- and sex-adjusted insulin-like growth factor 1 (IGF-1) concentration greater than the upper limit of normal (ULN); AND</p> <p>The treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information; AND</p> <p>The treatment must not be given concomitantly with a PBS-subsidised somatostatin analogue.</p> <p align=""justify"">Somatostatin analogues include octreotide, lanreotide and pasireotide</p> <p align=""justify"">Failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide is defined as:</p><p align=""justify"">1) Growth hormone level greater than 1 mcg/L or 3 mIU/L; OR</p><p align=""justify"">2) IGF-1 level is greater than the age- and sex-adjusted ULN.</p> <p align=""justify"">If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of contraindication.</p> <p align=""justify"">If intolerance to either octreotide or lanreotide treatment developed during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission.</p> <p align=""justify"">Biochemical evidence of remission is defined as normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1).</p> <p align=""justify"">Two completed authority prescriptions should be submitted with the initial application for this drug. One prescription should be for the loading dose of 80 mg for a quantity of 4 vials of 20 mg with no repeats. The second prescription should be for subsequent doses, starting from 10 mg daily, and allowing dose adjustments in increments of 5 mg based on serum IGF-1 levels measured every 4 to 6 weeks in order to maintain the serum IGF-1 level within the age-adjusted normal range based on the dosage recommendations in the TGA-approved Product Information.</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">a) two completed authority prescription forms ; and</p><p align=""justify"">b) a completed Acromegaly Pegvisomant initial PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">c) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy, the date and result of IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy; and</p><p align=""justify"">d) a recent result of the IGF-1 level and the date of assessment ; and</p><p align=""justify"">e) demonstration of failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Department of Human Services website at www.humanservices.gov.au</p><p align=""justify"">Applications for authority to prescribe should be forwarded to:</p><p align=""justify"">Department of Human Services</p><p align=""justify"">Complex Drugs Programs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">No increase in the maximum quantity or number of units may be authorised for the loading dose.</p>","N","N","Y","FULL","ALL","Y","2019-07-01","Y","4708"
"9061_9069_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","9069","9061","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2019-08-01","Y","4708"
"9072_9074_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","9074","9072","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align=""justify"">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align=""justify"">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">(1) a completed authority prescription form(s); and</p><p align=""justify"">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2019-08-01","Y","4708"
"9086_N","null","null","null","null","null","<p>The units used to express the potency of botulinum toxin preparations currently available for PBS subsidy are not equivalent.</p>","Y","N","N","null","null","N","2013-10-01","N","4708"
"9087_9088_R","Initial treatment","AUTHORITY_REQUIRED","9088","9087","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>Initial treatment</p><br/><p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have a mean growth hormone (GH) level greater than 1 microgram per litre or 3 mlU/L; or</p> <p>Patient must have an age- and sex-adjusted insulin-like growth factor 1 (IGF-1) concentration greater than the upper limit of normal (ULN); AND</p> <p>The treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised pegvisomant; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of contraindication.</p> <p align=""justify"">If intolerance to either octreotide or lanreotide treatment developed during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">Failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide is defined as:</p><p align=""justify"">1) Growth hormone level greater than 1 mcg/L or 3 mIU/L; OR</p><p align=""justify"">2) IGF-1 level is greater than the age- and sex-adjusted ULN.</p> <p align=""justify"">In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.</p> <p align=""justify"">Biochemical evidence of remission is defined as:</p><p align=""justify"">1) Growth hormone (GH) levels of less than 1 mcg/L or 3 mlU/L; OR</p><p align=""justify"">2) normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1)</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">a) a completed authority prescription form; and</p><p align=""justify"">b) a completed Acromegaly PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">c) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; the date and result of GH or IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided; and</p><p align=""justify"">d) a recent result of GH or IGF-1 levels must be provided.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory due to high risk of developing hyperglycaemia</p> <p>Acromegaly</p><br/><p>Initial treatment</p><br/><p>Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have a mean growth hormone (GH) level greater than 1 microgram per litre or 3 mlU/L; or</p> <p>Patient must have an age- and sex-adjusted insulin-like growth factor 1 (IGF-1) concentration greater than the upper limit of normal (ULN); AND</p> <p>The treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised pegvisomant; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of contraindication.</p> <p align=""justify"">If intolerance to either octreotide or lanreotide treatment developed during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.</p> <p align=""justify"">Failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide is defined as:</p><p align=""justify"">1) Growth hormone level greater than 1 mcg/L or 3 mIU/L; OR</p><p align=""justify"">2) IGF-1 level is greater than the age- and sex-adjusted ULN.</p> <p align=""justify"">In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.</p> <p align=""justify"">Biochemical evidence of remission is defined as:</p><p align=""justify"">1) Growth hormone (GH) levels of less than 1 mcg/L or 3 mlU/L; OR</p><p align=""justify"">2) normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1)</p> <p align=""justify"">The authority application must be made in writing and must include:</p><p align=""justify"">a) a completed authority prescription form; and</p><p align=""justify"">b) a completed Acromegaly PBS Authority Application - Supporting Information Form; and</p><p align=""justify"">c) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; the date and result of GH or IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided; and</p><p align=""justify"">d) a recent result of GH or IGF-1 levels must be provided.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2019-08-01","Y","4708"
"9106_9064_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","9064","9106","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2019-08-01","N","4708"
"9121_9063_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","9063","9121","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2019-08-01","N","4708"
"9139_9111_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","9111","9139","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 22 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions.</p> <p align=""justify"">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2019-08-01","N","4708"
"9144_9089_R","Continuing treatment","AUTHORITY_REQUIRED","9089","9144","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised pegvisomant; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.</p> <p align=""justify"">Biochemical evidence of remission is defined as:</p><p align=""justify"">1) Growth hormone (GH) levels of less than 1 mcg/L or 3 mlU/L; OR</p><p align=""justify"">2) normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1)</p> <p align=""justify"">In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy and the GH and IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of approval.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory due to high risk of developing hyperglycaemia</p> <p>Acromegaly</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised pegvisomant; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.</p> <p align=""justify"">Biochemical evidence of remission is defined as:</p><p align=""justify"">1) Growth hormone (GH) levels of less than 1 mcg/L or 3 mlU/L; OR</p><p align=""justify"">2) normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1)</p> <p align=""justify"">In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy and the GH and IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of approval.</p> <p align=""justify"">Applications for authorisation under this criterion may be made by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Written applications for authorisation under this criterion should be forwarded to:</p><p align=""justify"">Department of Human Services</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","IMMEDIATE","ALL","N","2019-08-01","N","4708"
"9168_9185_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","9185","9168","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 18 to 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 18 to 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 18 to 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 18 to 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align=""justify"">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2019-08-01","N","4708"
"9182_9188_R","Subsequent continuing treatment","STREAMLINED","9188","9182","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2019-08-01","N","4708"
"9190_9068_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","9068","9190","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.</p> <p align=""justify"">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2019-08-01","N","4708"
"9198_9204_R","Initial treatment","AUTHORITY_REQUIRED","9204","9198","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Aggressive systemic mastocytosis with eosinophilia</p><br/><p>Initial treatment</p><br/><p>Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND</p> <p>Patient must have previously failed an adequate trial of conventional therapy with corticosteroids; or</p> <p>Patient must have previously failed an adequate trial of conventional therapy with hydroxycarbamide (hydroxyurea); AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day.</p> <p align=""justify"">A pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene, a bone marrow biopsy report and/or other tissue biopsy report confirming the diagnosis of aggressive systemic mastocytosis and a full blood examination report demonstrating eosinophilia must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The details of symptomatic organ involvement requiring treatment, including radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Aggressive systemic mastocytosis with eosinophilia</p><br/><p>Initial treatment</p><br/><p>Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND</p> <p>Patient must have previously failed an adequate trial of conventional therapy with corticosteroids; or</p> <p>Patient must have previously failed an adequate trial of conventional therapy with hydroxycarbamide (hydroxyurea); AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day.</p> <p align=""justify"">A pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene, a bone marrow biopsy report and/or other tissue biopsy report confirming the diagnosis of aggressive systemic mastocytosis and a full blood examination report demonstrating eosinophilia must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The details of symptomatic organ involvement requiring treatment, including radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9199_9238_R","Initial treatment","AUTHORITY_REQUIRED","9238","9199","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastrointestinal stromal tumour</p><br/><p>Initial treatment</p><br/><p>The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND</p> <p>Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND</p> <p>The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND</p> <p>The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy).</p> <p align=""justify"">High risk of recurrence is defined as:</p><p align=""justify"">Primary GIST greater than 5 cm with a mitotic count of greater than 5/50 high power fields (HPF); or</p><p align=""justify"">Primary GIST greater than 10 cm with any mitotic rate; or</p><p align=""justify"">Primary GIST with a mitotic count of greater than 10/50 HPF.</p> <p align=""justify"">A pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection, which must not be more than 3 months prior to treatment initiation must be recorded in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Gastrointestinal stromal tumour</p><br/><p>Initial treatment</p><br/><p>The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND</p> <p>Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND</p> <p>The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND</p> <p>The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy).</p> <p align=""justify"">High risk of recurrence is defined as:</p><p align=""justify"">Primary GIST greater than 5 cm with a mitotic count of greater than 5/50 high power fields (HPF); or</p><p align=""justify"">Primary GIST greater than 10 cm with any mitotic rate; or</p><p align=""justify"">Primary GIST with a mitotic count of greater than 10/50 HPF.</p> <p align=""justify"">A pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining must be documented in the patient&apos;s medical records.</p> <p align=""justify"">The pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection, which must not be more than 3 months prior to treatment initiation must be recorded in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9201_9319_R","Initial Treatment","AUTHORITY_REQUIRED","9319","9201","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Malignant gastrointestinal stromal tumour</p><br/><p>Initial Treatment</p><br/><p>The condition must be metastatic; or</p> <p>The condition must be unresectable; AND</p> <p>The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND</p> <p>The treatment must be commenced at a dose not exceeding 400 mg per day; AND</p> <p>The treatment must not exceed 3 months under this restriction.</p> <p>Authority prescriptions for a higher dose will not be approved during this initial 3 month treatment period.</p> <p align=""justify"">Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.</p><p align=""justify"">A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.)</p> <p align=""justify"">A pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Details of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour(s), including whether or not there is evidence of metastatic disease must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Malignant gastrointestinal stromal tumour</p><br/><p>Initial Treatment</p><br/><p>The condition must be metastatic; or</p> <p>The condition must be unresectable; AND</p> <p>The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND</p> <p>The treatment must be commenced at a dose not exceeding 400 mg per day; AND</p> <p>The treatment must not exceed 3 months under this restriction.</p> <p>Authority prescriptions for a higher dose will not be approved during this initial 3 month treatment period.</p> <p align=""justify"">Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.</p><p align=""justify"">A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.)</p> <p align=""justify"">A pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Details of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour(s), including whether or not there is evidence of metastatic disease must be documented in the patient&apos;s medical records.</p> <p align=""justify"">Where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9211_9247_R","Initial treatment","STREAMLINED","9247","9211","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) soft tissue sarcoma</p><br/><p>Initial treatment</p><br/><p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have received prior chemotherapy treatment including an anthracycline; AND</p> <p>Patient must not have received prior treatment with an angiogenesis inhibitor; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Patient must not have any of the following conditions:</p><p align=""justify"">adipocytic soft tissue sarcoma;</p><p align=""justify"">gastrointestinal stromal tumour (GIST);</p><p align=""justify"">rhabdomyosarcoma other than alveolar or pleomorphic;</p><p align=""justify"">chondrosarcoma;</p><p align=""justify"">osteosarcoma;</p><p align=""justify"">Ewings tumour/primitive neuroectodermal tumour;</p><p align=""justify"">dermofibromatosis sarcoma protuberans;</p><p align=""justify"">inflammatory myofibroblastic sarcoma;</p><p align=""justify"">malignant mesothelioma;</p><p align=""justify"">mixed mesodermal tumour of the uterus.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Advanced (unresectable and/or metastatic) soft tissue sarcoma</p><br/><p>Initial treatment</p><br/><p>Patient must have a WHO performance status of 2 or less; AND</p> <p>Patient must have received prior chemotherapy treatment including an anthracycline; AND</p> <p>Patient must not have received prior treatment with an angiogenesis inhibitor; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition.</p> <p align=""justify"">Patient must not have any of the following conditions:</p><p align=""justify"">adipocytic soft tissue sarcoma;</p><p align=""justify"">gastrointestinal stromal tumour (GIST);</p><p align=""justify"">rhabdomyosarcoma other than alveolar or pleomorphic;</p><p align=""justify"">chondrosarcoma;</p><p align=""justify"">osteosarcoma;</p><p align=""justify"">Ewings tumour/primitive neuroectodermal tumour;</p><p align=""justify"">dermofibromatosis sarcoma protuberans;</p><p align=""justify"">inflammatory myofibroblastic sarcoma;</p><p align=""justify"">malignant mesothelioma;</p><p align=""justify"">mixed mesodermal tumour of the uterus.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9216_C","null","null","null","null","null","<p align=""justify"">Monitor for post-injection syndrome for at least two hours after each injection.</p>","N","Y","N","null","null","N","2013-11-01","N","4708"
"9221_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form olanzapine tablet 5 mg (orally disintegrating) and pharmaceutical benefits that have the form olanzapine wafer 5 mg are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-04-01","N","4708"
"9222_9222_R","Continuing treatment","STREAMLINED","9222","9222","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Continuing treatment</p><br/><p>Patient must not be transfusion dependent; AND</p> <p>The condition must be thalassaemia; AND</p> <p>Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Continuing treatment</p><br/><p>Patient must not be transfusion dependent; AND</p> <p>The condition must be thalassaemia; AND</p> <p>Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9222_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form olanzapine tablet 10 mg (orally disintegrating) and pharmaceutical benefits that have the form olanzapine wafer 10 mg are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-04-01","N","4708"
"9223_9223_R","null","STREAMLINED","9223","9223","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Kaposi sarcoma</p><br/><p>The condition must be AIDS-related; AND</p> <p>Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND</p> <p>The condition must include extensive visceral involvement.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Kaposi sarcoma</p><br/><p>The condition must be AIDS-related; AND</p> <p>Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND</p> <p>The condition must include extensive visceral involvement.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9223_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form olanzapine tablet 15 mg (orally disintegrating) and pharmaceutical benefits that have the form olanzapine wafer 15 mg are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-04-01","N","4708"
"9224_9224_R","null","STREAMLINED","9224","9224","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must be at greater than 20% risk of developing febrile neutropenia; or</p> <p>Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must be at greater than 20% risk of developing febrile neutropenia; or</p> <p>Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9224_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form olanzapine tablet 20 mg (orally disintegrating) and pharmaceutical benefits that have the form olanzapine wafer 20 mg are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-04-01","N","4708"
"9228_9228_R","null","STREAMLINED","9228","9228","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron overload</p><br/><p>Patient must have thalassaemia major; AND</p> <p>Patient must be one in whom desferrioxamine therapy has proven ineffective.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron overload</p><br/><p>Patient must have thalassaemia major; AND</p> <p>Patient must be one in whom desferrioxamine therapy has proven ineffective.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9232_9232_R","null","STREAMLINED","9232","9232","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vasoactive intestinal peptide secreting tumour (VIPoma)</p><br/><p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months'' therapy.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vasoactive intestinal peptide secreting tumour (VIPoma)</p><br/><p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months'' therapy.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9233_9233_R","null","STREAMLINED","9233","9233","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>The condition must be active; AND</p> <p>Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND</p> <p>The treatment must be after failure of other therapy including dopamine agonists; or</p> <p>The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or</p> <p>The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.</p> <p align=""justify"">In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>The condition must be active; AND</p> <p>Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND</p> <p>The treatment must be after failure of other therapy including dopamine agonists; or</p> <p>The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or</p> <p>The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.</p> <p align=""justify"">In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission </p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9234_9234_R","null","STREAMLINED","9234","9234","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia of malignancy</p><br/><p>Patient must have a malignancy refractory to anti-neoplastic therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hypercalcaemia of malignancy</p><br/><p>Patient must have a malignancy refractory to anti-neoplastic therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9235_9235_R","null","STREAMLINED","9235","9235","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must be at greater than 20% risk of developing febrile neutropenia; or</p> <p>Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must be at greater than 20% risk of developing febrile neutropenia; or</p> <p>Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9237_4179_R","null","RESTRICTED","4179","9237","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9244_9274_R","Initial treatment","AUTHORITY_REQUIRED","9274","9244","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic eosinophilic leukaemia or Hypereosinophilic syndrome</p><br/><p>Initial treatment</p><br/><p>Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day.</p> <p align=""justify"">A pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene, a full blood examination report and details of organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate must be documented in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic eosinophilic leukaemia or Hypereosinophilic syndrome</p><br/><p>Initial treatment</p><br/><p>Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND</p> <p>The treatment must not exceed a maximum dose of 400 mg per day.</p> <p align=""justify"">A pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene, a full blood examination report and details of organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate must be documented in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9251_N","null","null","null","null","null","<p/><p align=""justify"">A patient who has had progressive disease when treated with another BRAF inhibitor is not eligible to receive PBS-subsidised treatment with this drug.</p><p/>","Y","N","N","null","null","N","2013-12-01","N","4708"
"9258_9258_R","Continuing treatment","STREAMLINED","9258","9258","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Continuing treatment</p><br/><p>Patient must be red blood cell transfusion dependent; AND</p> <p>Patient must have a malignant disorder of haemopoieisis; AND</p> <p>Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Continuing treatment</p><br/><p>Patient must be red blood cell transfusion dependent; AND</p> <p>Patient must have a malignant disorder of haemopoieisis; AND</p> <p>Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.</p> <p align=""justify"">Interruption of treatment should be considered if serum ferritin levels fall consistently below 500 microgram/mL.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9258_N","null","null","null","null","null","<p/><p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.</p><p/>","Y","N","N","null","null","N","2013-12-01","N","4708"
"9260_9260_R","null","STREAMLINED","9260","9260","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months'' therapy at a dose of 120 mg every 28 days.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months'' therapy at a dose of 120 mg every 28 days.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9261_9261_R","null","STREAMLINED","9261","9261","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>The condition must be active; AND</p> <p>Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND</p> <p>The treatment must be after failure of other therapy including dopamine agonists; or</p> <p>The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or</p> <p>The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised pegvisomant.</p> <p align=""justify"">In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>The condition must be active; AND</p> <p>Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND</p> <p>The treatment must be after failure of other therapy including dopamine agonists; or</p> <p>The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or</p> <p>The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised pegvisomant.</p> <p align=""justify"">In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. </p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9262_9262_R","null","STREAMLINED","9262","9262","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>The condition must be controlled with octreotide immediate release injections; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.</p> <p align=""justify"">In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acromegaly</p><br/><p>The condition must be controlled with octreotide immediate release injections; AND</p> <p>The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND</p> <p>The treatment must cease if IGF1 is not lower after 3 months of treatment; AND</p> <p>The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.</p> <p align=""justify"">In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission </p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9267_9267_R","Prophylaxis","STREAMLINED","9267","9267","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Prophylaxis</p><br/><p>Patient must have undergone a renal transplant; AND</p> <p>Patient must be at risk of cytomegalovirus disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cytomegalovirus infection and disease</p><br/><p>Prophylaxis</p><br/><p>Patient must have undergone a renal transplant; AND</p> <p>Patient must be at risk of cytomegalovirus disease.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9286_9286_R","null","STREAMLINED","9286","9286","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron overload</p><br/><p>Patient must have thalassaemia major; AND</p> <p>Patient must be unable to take desferrioxamine therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron overload</p><br/><p>Patient must have thalassaemia major; AND</p> <p>Patient must be unable to take desferrioxamine therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9287_9287_R","null","STREAMLINED","9287","9287","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Kaposi sarcoma</p><br/><p>The condition must be AIDS-related; AND</p> <p>Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND</p> <p>The condition must include extensive mucocutaneous involvement.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Kaposi sarcoma</p><br/><p>The condition must be AIDS-related; AND</p> <p>Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND</p> <p>The condition must include extensive mucocutaneous involvement.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9288_9288_R","null","STREAMLINED","9288","9288","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vasoactive intestinal peptide secreting tumour (VIPoma)</p><br/><p>Patient must have achieved symptom control on octreotide immediate release injections; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Vasoactive intestinal peptide secreting tumour (VIPoma)</p><br/><p>Patient must have achieved symptom control on octreotide immediate release injections; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9289_9289_R","null","STREAMLINED","9289","9289","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months'' therapy.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>The condition must be causing intractable symptoms; AND</p> <p>Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND</p> <p>Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months'' therapy.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9290_9290_R","null","STREAMLINED","9290","9290","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align=""justify"">Thalidomide is a category X drug and must not be given to pregnant women. Pregnancy in female patients or in the partners of male patients must be avoided during treatment and for 1 month after cessation of treatment.</p> <p>Multiple myeloma</p> <p>Patients receiving thalidomide under the PBS listing must be registered in the i-access risk management program.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9292_4171_R","null","RESTRICTED","4171","9292","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must have malignant neoplasia.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must have malignant neoplasia.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9302_9302_R","Continuing treatment","STREAMLINED","9302","9302","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Continuing treatment</p><br/><p>Patient must be transfusion dependent; AND</p> <p>Patient must not have a malignant disorder of erythropoiesis; AND</p> <p>Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic iron overload</p><br/><p>Continuing treatment</p><br/><p>Patient must be transfusion dependent; AND</p> <p>Patient must not have a malignant disorder of erythropoiesis; AND</p> <p>Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9303_9303_R","null","STREAMLINED","9303","9303","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must have had a prior episode of febrile neutropenia; or</p> <p>Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must have had a prior episode of febrile neutropenia; or</p> <p>Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9305_4180_R","null","RESTRICTED","4180","9305","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; AND</p> <p>The condition must be unresponsive to other oral therapies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; AND</p> <p>The condition must be unresponsive to other oral therapies.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9306_6170_R","null","STREAMLINED","6170","9306","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving palliative care.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Constipation</p><br/><p>Patient must be receiving palliative care.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9313_9313_R","null","STREAMLINED","9313","9313","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>Patient must have achieved symptom control on octreotide immediate release injections; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Functional carcinoid tumour</p><br/><p>Patient must have achieved symptom control on octreotide immediate release injections; AND</p> <p>The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.</p> <p align=""justify"">Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9315_9315_R","null","STREAMLINED","9315","9315","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to breast cancer.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bone metastases</p><br/><p>The condition must be due to breast cancer.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9318_4173_R","null","RESTRICTED","4173","9318","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic constipation</p><br/><p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic constipation</p><br/><p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9322_9322_R","null","STREAMLINED","9322","9322","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must have had a prior episode of febrile neutropenia; or</p> <p>Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chemotherapy-induced neutropenia</p><br/><p>Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND</p> <p>Patient must have had a prior episode of febrile neutropenia; or</p> <p>Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9329_9329_R","null","STREAMLINED","9329","9329","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mobilisation of haematopoietic stem cells</p><br/><p>The treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); AND</p> <p>Patient must have lymphoma; or</p> <p>Patient must have multiple myeloma; AND</p> <p>Patient must require autologous stem cell transplantation; AND</p> <p>Patient must have failed previous stem cell collection; or</p> <p>Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; or</p> <p>Patient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.</p> <p/><p align=""justify"">Evidence that the patient meets the PBS restriction criteria must be recorded in the patient&apos;s medical records.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mobilisation of haematopoietic stem cells</p><br/><p>The treatment must be in combination with granulocyte-colony stimulating factor (G-CSF); AND</p> <p>Patient must have lymphoma; or</p> <p>Patient must have multiple myeloma; AND</p> <p>Patient must require autologous stem cell transplantation; AND</p> <p>Patient must have failed previous stem cell collection; or</p> <p>Patient must be undergoing chemotherapy plus G-CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; or</p> <p>Patient must be undergoing chemotherapy plus G-CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.</p> <p/><p align=""justify"">Evidence that the patient meets the PBS restriction criteria must be recorded in the patient&apos;s medical records.</p><p/> <p align=""justify"">Applications for increased maximum quantities will only be authorised for patients with body weight greater than 100 kg. </p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9330_4177_R","null","RESTRICTED","4177","9330","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Faecal impaction</p><br/><p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Faecal impaction</p><br/><p>The condition must be inadequately controlled with first line interventions such as bulk-forming agents.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9334_9334_R","null","STREAMLINED","9334","9334","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe spasticity of the lower limb following an acute event</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a plastic surgeon; or</p> <p>Must be treated by a geriatrician; AND</p> <p>The condition must be moderate to severe spasticity of the lower limb/s following stroke or other acute neurological event, defined as a Modified Ashworth Scale rating of 3 or more; AND</p> <p>The treatment must only be used as second line therapy when standard management has failed; or</p> <p>The treatment must only be used as an adjunct to physical therapy; AND</p> <p>The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND</p> <p>Patient must not have established severe contracture in the limb to be treated; AND</p> <p>The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Standard management includes physiotherapy and/or oral spasticity agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe spasticity of the lower limb following an acute event</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a plastic surgeon; or</p> <p>Must be treated by a geriatrician; AND</p> <p>The condition must be moderate to severe spasticity of the lower limb/s following stroke or other acute neurological event, defined as a Modified Ashworth Scale rating of 3 or more; AND</p> <p>The treatment must only be used as second line therapy when standard management has failed; or</p> <p>The treatment must only be used as an adjunct to physical therapy; AND</p> <p>The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND</p> <p>Patient must not have established severe contracture in the limb to be treated; AND</p> <p>The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Standard management includes physiotherapy and/or oral spasticity agents.</p> <p align=""justify"">An acute event may be a clinical or external event that leads to upper motor neuron lesions resulting in spasticity for example stroke, traumatic brain injury, spinal cord injury, infection or hypoxia.</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9335_9335_R","null","STREAMLINED","9335","9335","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple myeloma</p>","N","N","N","IMMEDIATE","ALL","N","2019-09-01","N","4708"
"9357_9462_R","Continuing treatment","STREAMLINED","9462","9357","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9374_9472_R","Subsequent continuing treatment","STREAMLINED","9472","9374","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""justify"">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align=""justify"">either of the following:</p><p align=""justify"">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align=""justify"">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align=""justify"">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align=""justify"">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align=""justify"">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align=""justify"">The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient&apos;s medical records.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9379_9380_R","Continuing Treatment - balance of supply","AUTHORITY_REQUIRED","9380","9379","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing Treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Continuing Treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p> <p align=""justify"">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9389_9386_R","Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply","AUTHORITY_REQUIRED","9386","9389","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p> <p align=""justify"">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9409_C","null","null","null","null","null","<p/><p align=""justify"">Teriflunomide is a category X drug and must not be given to pregnant women or women of childbearing potential who are not currently using reliable contraception.</p><p/><p align=""justify""> Pregnancy should be avoided for two years after cessation of therapy, unless special wash-out procedures are carried out. </p><p/>","N","Y","N","null","null","N","2013-12-01","N","4708"
"9460_9349_R","Continuing treatment","STREAMLINED","9349","9460","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">Where a patient has a break in trastuzumab therapy of more than 1 week from when the last dose was due, a new loading dose may be required.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">Where a patient has a break in trastuzumab therapy of more than 1 week from when the last dose was due, a new loading dose may be required.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9471_9584_R","Subsequent continuing treatment, Face, hand, foot","STREAMLINED","9584","9471","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align=""justify"">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align=""justify"">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9488_9488_R","null","STREAMLINED","9488","9488","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity of cerebral origin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity of cerebral origin.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9489_9489_R","null","STREAMLINED","9489","9489","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord injury.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord injury.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9523_9523_R","Initial treatment","STREAMLINED","9523","9523","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a neurologist.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a neurologist.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9524_9524_R","null","STREAMLINED","9524","9524","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord disease.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9525_9525_R","null","STREAMLINED","9525","9525","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to multiple sclerosis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to multiple sclerosis.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9527_9527_R","null","STREAMLINED","9527","9527","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must be intolerant or inadequately responsive to dornase alfa; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.</p> <p align=""justify"">Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.</p> <p align=""justify"">To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:</p><p align=""justify"">(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND</p><p align=""justify"">(2) the patient or the patient&apos;s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>The treatment must be as monotherapy; AND</p> <p>Patient must be intolerant or inadequately responsive to dornase alfa; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.</p> <p align=""justify"">Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.</p> <p align=""justify"">To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:</p><p align=""justify"">(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND</p><p align=""justify"">(2) the patient or the patient&apos;s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. </p> <p>It is highly desirable that all patients be included in the national cystic fibrosis patient database.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9545_9360_R","Continuing treatment","STREAMLINED","9360","9545","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>The treatment must be in combination with capecitabine; AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised anti-HER2 therapy for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.</p><p align=""justify"">The treatment must not exceed a lifetime total of one continuous course.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Continuing treatment</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>The treatment must be in combination with capecitabine; AND</p> <p>Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised anti-HER2 therapy for this condition; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.</p><p align=""justify"">The treatment must not exceed a lifetime total of one continuous course.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9552_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form esomeprazole tablet 20 mg and pharmaceutical benefits that have the form esomeprazole capsule 20 mg are equivalent for the purposes of substitution. </p>","Y","N","N","null","null","N","2014-01-01","N","4708"
"9560_9560_R","null","STREAMLINED","9560","9560","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycobacterium avium complex infection</p><br/><p>Patient must be human immunodeficiency virus (HIV) positive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycobacterium avium complex infection</p><br/><p>Patient must be human immunodeficiency virus (HIV) positive.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9562_9562_R","null","STREAMLINED","9562","9562","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity of cerebral origin.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity of cerebral origin.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9570_9571_R","Continuing treatment","STREAMLINED","9571","9570","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have progressive disease; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9574_9353_R","Initial treatment","STREAMLINED","9353","9574","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND</p> <p>The treatment must not be in combination with nab-paclitaxel; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive breast cancer</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND</p> <p>The treatment must not be in combination with nab-paclitaxel; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9586_9632_R","null","STREAMLINED","9632","9586","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute severe ulcerative colitis</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology]; AND</p> <p>Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND</p> <p>Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; or</p> <p>Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND</p> <p>Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital; AND</p> <p>Patient must be 6 years of age or older.</p> <p/><p align=""justify"">For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where:</p><p/><p align=""justify"">(i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L</p><p/><p align=""justify"">(ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood.</p><p/><p align=""justify"">For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours.</p><p/> <p/><p align=""justify"">At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.</p><p/><p align=""justify"">Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient&apos;s medical records.</p><p/> <p/><p align=""justify"">Evidence that the patient meets the PBS restriction criteria must be recorded in the patient&apos;s medical records.</p><p/>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute severe ulcerative colitis</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology]; AND</p> <p>Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND</p> <p>Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; or</p> <p>Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND</p> <p>Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital; AND</p> <p>Patient must be 6 years of age or older.</p> <p/><p align=""justify"">For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where:</p><p/><p align=""justify"">(i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L</p><p/><p align=""justify"">(ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood.</p><p/><p align=""justify"">For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours.</p><p/> <p/><p align=""justify"">At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.</p><p/><p align=""justify"">Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient&apos;s medical records.</p><p/> <p/><p align=""justify"">Evidence that the patient meets the PBS restriction criteria must be recorded in the patient&apos;s medical records.</p><p/>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9589_9589_R","Continuing treatment","STREAMLINED","9589","9589","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must not receive more than one PBS-subsidised treatment per year; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a neurologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>Patient must not receive more than one PBS-subsidised treatment per year; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a neurologist.</p> <p align=""left"">Neurologists prescribing PBS-subsidised alemtuzumab must be registered with the Lemtrada monitoring program.</p> <p align=""justify"">Special Pricing Arrangements apply.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9590_9590_R","null","STREAMLINED","9590","9590","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron overload</p><br/><p>Patient must have thalassaemia major; AND</p> <p>Patient must be one in whom desferrioxamine therapy has proven ineffective.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron overload</p><br/><p>Patient must have thalassaemia major; AND</p> <p>Patient must be one in whom desferrioxamine therapy has proven ineffective.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9591_9591_R","null","STREAMLINED","9591","9591","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; or</p> <p>Patient must have significant bronchiectasis on chest high resolution computed tomography scan; or</p> <p>Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; or</p> <p>Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy; AND</p> <p>Patient must be less than 5 years of age.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; or</p> <p>Patient must have significant bronchiectasis on chest high resolution computed tomography scan; or</p> <p>Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; or</p> <p>Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy; AND</p> <p>Patient must be less than 5 years of age.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals.</p> <p>It is highly desirable that all patients be included in the national cystic fibrosis patient database.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9592_9592_R","Continuing treatment","STREAMLINED","9592","9592","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have initiated treatment with dornase alfa at an age of less than 5 years; AND</p> <p>Patient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit; AND</p> <p>Patient must be 5 years of age or older.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have initiated treatment with dornase alfa at an age of less than 5 years; AND</p> <p>Patient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit; AND</p> <p>Patient must be 5 years of age or older.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.</p> <p>It is highly desirable that all patients be included in the national cystic fibrosis patient database.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9593_9593_R","null","STREAMLINED","9593","9593","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>The treatment must be in combination with dornase alfa; AND</p> <p>Patient must be inadequately responsive to dornase alfa; AND</p> <p>Patient must have trialled hypertonic saline for this condition; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.</p> <p align=""justify"">Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.</p> <p align=""justify"">To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:</p><p align=""justify"">(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND</p><p align=""justify"">(2) the patient or the patient&apos;s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>The treatment must be in combination with dornase alfa; AND</p> <p>Patient must be inadequately responsive to dornase alfa; AND</p> <p>Patient must have trialled hypertonic saline for this condition; AND</p> <p>Patient must be 6 years of age or older.</p> <p align=""justify"">Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.</p> <p align=""justify"">Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.</p> <p align=""justify"">To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:</p><p align=""justify"">(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND</p><p align=""justify"">(2) the patient or the patient&apos;s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. </p> <p>It is highly desirable that all patients be included in the national cystic fibrosis patient database.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9598_9573_R","Initial treatment","STREAMLINED","9573","9598","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; AND</p> <p>Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in the same tumour tissue sample; AND</p> <p>Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on the ratio of HER2 to chromosome 17 being more than 2 in the same tumour tissue sample; AND</p> <p>Patient must commence treatment in combination with platinum based chemotherapy and capecitabine; or</p> <p>Patient must commence treatment in combination with platinum based chemotherapy and 5 fluorouracil; AND</p> <p>Patient must not have previously received this drug for this condition; AND</p> <p>Patient must not have received prior chemotherapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction</p><br/><p>Initial treatment</p><br/><p>Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; AND</p> <p>Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in the same tumour tissue sample; AND</p> <p>Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on the ratio of HER2 to chromosome 17 being more than 2 in the same tumour tissue sample; AND</p> <p>Patient must commence treatment in combination with platinum based chemotherapy and capecitabine; or</p> <p>Patient must commence treatment in combination with platinum based chemotherapy and 5 fluorouracil; AND</p> <p>Patient must not have previously received this drug for this condition; AND</p> <p>Patient must not have received prior chemotherapy for this condition; AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.</p> <p align=""justify"">Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9604_9604_R","null","STREAMLINED","9604","9604","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycobacterium avium complex infection</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be human immunodeficiency virus (HIV) positive; AND</p> <p>Patient must have CD4 cell counts of less than 75 per cubic millimetre.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycobacterium avium complex infection</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be human immunodeficiency virus (HIV) positive; AND</p> <p>Patient must have CD4 cell counts of less than 75 per cubic millimetre.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9605_9490_R","Initial treatment","STREAMLINED","9490","9605","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Initial treatment</p><br/><p>Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient; AND</p> <p>Patient must be non-responsive to other neuroleptic agents; or</p> <p>Patient must be intolerant of other neuroleptic agents.</p> <p align=""justify"">Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.</p> <p>The name of the consulting psychiatrist should be included in the patient&apos;s medical records.</p> <p align=""justify"">A medical practitioner should request a quantity sufficient for up to one month&apos;s supply. Up to 5 repeats will be authorised. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Schizophrenia</p><br/><p>Initial treatment</p><br/><p>Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient; AND</p> <p>Patient must be non-responsive to other neuroleptic agents; or</p> <p>Patient must be intolerant of other neuroleptic agents.</p> <p align=""justify"">Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.</p> <p>The name of the consulting psychiatrist should be included in the patient&apos;s medical records.</p> <p align=""justify"">A medical practitioner should request a quantity sufficient for up to one month&apos;s supply. Up to 5 repeats will be authorised. </p> <p align=""justify"">Patients receiving clozapine under the PBS listing must be registered in the clozapine patient monitoring program relevant for the brand of clozapine being prescribed and dispensed: Pfizer ClopineCentral.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9606_9606_R","null","STREAMLINED","9606","9606","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord disease.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9616_9602_R","Subsequent continuing treatment, Whole body","STREAMLINED","9602","9616","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align=""justify"">An adequate response to treatment is defined as:</p><p align=""left"">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""left"">Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9622_9622_R","null","STREAMLINED","9622","9622","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycobacterium avium complex infection</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be human immunodeficiency virus (HIV) positive; AND</p> <p>Patient must have CD4 cell counts of less than 75 per cubic millimetre.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Mycobacterium avium complex infection</p><br/><p>The treatment must be for prophylaxis; AND</p> <p>Patient must be human immunodeficiency virus (HIV) positive; AND</p> <p>Patient must have CD4 cell counts of less than 75 per cubic millimetre.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9623_9623_R","null","STREAMLINED","9623","9623","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron overload</p><br/><p>Patient must have thalassaemia major; AND</p> <p>Patient must be unable to take desferrioxamine therapy.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Iron overload</p><br/><p>Patient must have thalassaemia major; AND</p> <p>Patient must be unable to take desferrioxamine therapy.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9624_9624_R","null","STREAMLINED","9624","9624","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Patient must be 5 years of age or older.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.</p> <p align=""justify"">Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily.</p> <p align=""justify"">To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:</p><p align=""justify"">(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND</p><p align=""justify"">(2) the patient or the patient&apos;s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. </p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Cystic fibrosis</p><br/><p>Patient must be 5 years of age or older.</p> <p align=""justify"">Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.</p> <p align=""justify"">Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.</p> <p align=""justify"">Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily.</p> <p align=""justify"">To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:</p><p align=""justify"">(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND</p><p align=""justify"">(2) the patient or the patient&apos;s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.</p> <p align=""justify"">Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. </p> <p>It is highly desirable that all patients be included in the national cystic fibrosis patient database.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9635_9635_R","Continuing treatment","STREAMLINED","9635","9635","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a neurologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not show continuing progression of disability while on treatment with this drug; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND</p> <p>Must be treated by a neurologist.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9636_9636_R","Initial treatment","STREAMLINED","9636","9636","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a neurologist.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Multiple sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or</p> <p>The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND</p> <p>The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND</p> <p>Patient must be ambulatory (without assistance or support); AND</p> <p>Must be treated by a neurologist.</p> <p align=""justify"">Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient&apos;s medical records.</p> <p align=""left"">Neurologists prescribing PBS-subsidised alemtuzumab must be registered with the Lemtrada monitoring program.</p> <p align=""justify"">Special Pricing Arrangements apply.</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9637_9637_R","null","STREAMLINED","9637","9637","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to multiple sclerosis.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to multiple sclerosis.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9638_9638_R","null","STREAMLINED","9638","9638","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord injury.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic spasticity</p><br/><p>Patient must have failed to respond to treatment with oral antispastic agents; or</p> <p>Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND</p> <p>Patient must have chronic spasticity due to spinal cord injury.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9639_9639_R","null","STREAMLINED","9639","9639","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic granulomatous disease</p><br/><p>Patient must have frequent and severe infections despite adequate prophylaxis with antimicrobial agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic granulomatous disease</p><br/><p>Patient must have frequent and severe infections despite adequate prophylaxis with antimicrobial agents.</p>","N","N","N","IMMEDIATE","ALL","N","2019-10-01","N","4708"
"9642_4295_R","null","RESTRICTED","4295","9642","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Phenylketonuria</p> <p align=""justify"">This formulation is suitable for patients aged 3 and older.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9652_9705_R","Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)","AUTHORITY_REQUIRED","9705","9652","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A partial Mayo clinic assessment of the patient&apos;s response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Department of Human Services website.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A partial Mayo clinic assessment of the patient&apos;s response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Department of Human Services website.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2019-11-01","Y","4708"
"9653_9745_R","Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply","AUTHORITY_REQUIRED","9745","9653","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 14 weeks of treatment (weeks 0, 2, 6 and 10); AND</p> <p>The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment.</p> <p align=""justify"">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9688_9688_R","null","STREAMLINED","9688","9688","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaemia associated with intrinsic renal disease</p><br/><p>Patient must require transfusion; AND</p> <p>Patient must have a haemoglobin level of less than 100 g per L; AND</p> <p>Patient must have intrinsic renal disease, as assessed by a nephrologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Anaemia associated with intrinsic renal disease</p><br/><p>Patient must require transfusion; AND</p> <p>Patient must have a haemoglobin level of less than 100 g per L; AND</p> <p>Patient must have intrinsic renal disease, as assessed by a nephrologist.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9691_9691_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","9691","9691","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9692_9692_R","Management","STREAMLINED","9692","9692","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prophylaxis of renal allograft rejection</p><br/><p>Management</p><br/><p>The treatment must be under the supervision and direction of a transplant unit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Prophylaxis of renal allograft rejection</p><br/><p>Management</p><br/><p>The treatment must be under the supervision and direction of a transplant unit.</p> <p>Management includes initiation, stabilisation and review of therapy as required.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9693_9693_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","9693","9693","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of cardiac allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of cardiac allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9694_9694_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","9694","9694","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Nephrotic syndrome</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must have failed prior treatment with steroids and cytostatic drugs; or</p> <p>Patient must be intolerant to treatment with steroids and cytostatic drugs; or</p> <p>The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND</p> <p>Patient must not have renal impairment; AND</p> <p>Must be treated by a nephrologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Nephrotic syndrome</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must have failed prior treatment with steroids and cytostatic drugs; or</p> <p>Patient must be intolerant to treatment with steroids and cytostatic drugs; or</p> <p>The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND</p> <p>Patient must not have renal impairment; AND</p> <p>Must be treated by a nephrologist.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9695_9695_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","9695","9695","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe atopic dermatitis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>The condition must be ineffective to other systemic therapies; or</p> <p>The condition must be inappropriate for other systemic therapies.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Severe atopic dermatitis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist; AND</p> <p>The condition must be ineffective to other systemic therapies; or</p> <p>The condition must be inappropriate for other systemic therapies.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9696_9696_R","null","STREAMLINED","9696","9696","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Disorders of erythropoiesis</p><br/><p>The condition must be associated with treatment-related chronic iron overload.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Disorders of erythropoiesis</p><br/><p>The condition must be associated with treatment-related chronic iron overload.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9697_9697_R","null","STREAMLINED","9697","9697","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of rejection in patients following organ or tissue transplantation</p><br/><p>The treatment must be under the supervision and direction of a transplant unit; AND</p> <p>The treatment must include initiation, stabilisation, and review of therapy as required.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of rejection in patients following organ or tissue transplantation</p><br/><p>The treatment must be under the supervision and direction of a transplant unit; AND</p> <p>The treatment must include initiation, stabilisation, and review of therapy as required.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9725_9754_R","Balance of supply","AUTHORITY_REQUIRED","9754","9725","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 3 doses therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 3 doses therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.</p> <p align=""justify"">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9732_9732_R","Subsequent continuing treatment","STREAMLINED","9732","9732","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9742_9742_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","9742","9742","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active rheumatoid arthritis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); or</p> <p>The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate); AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Severe active rheumatoid arthritis</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); or</p> <p>The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate); AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9762_9762_R","Initiation and stabilisation","STREAMLINED","9762","9762","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>Initiation and stabilisation</p><br/><p>The condition must not be adequately controlled by calcium; AND</p> <p>Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or</p> <p>The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND</p> <p>The treatment must not be used in combination with any other non-calcium phosphate binding agents; AND</p> <p>Patient must be undergoing dialysis for chronic kidney disease.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Hyperphosphataemia</p><br/><p>Initiation and stabilisation</p><br/><p>The condition must not be adequately controlled by calcium; AND</p> <p>Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or</p> <p>The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND</p> <p>The treatment must not be used in combination with any other non-calcium phosphate binding agents; AND</p> <p>Patient must be undergoing dialysis for chronic kidney disease.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9764_9764_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","9764","9764","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of transplant rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must have had an organ or tissue transplantation; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of transplant rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must have had an organ or tissue transplantation; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9769_9770_R","Continuing treatment","AUTHORITY_REQUIRED","9770","9769","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align=""justify"">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align=""justify"">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align=""justify"">Authority applications for continuing treatment may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9785_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the form esomeprazole tablet 40 mg and pharmaceutical benefits that have the form esomeprazole capsule 40 mg are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2015-07-01","N","4708"
"9789_N","null","null","null","null","null","<p align=""justify"">No applications for increased maximum quantities and/or repeats will be authorised for the tablets containing 320 mg valsartan.</p>","Y","N","N","null","null","N","2014-01-01","N","4708"
"9804_9787_R","Subsequent continuing treatment","STREAMLINED","9787","9804","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug.</p> <p align=""justify"">An adequate response is defined as:</p><p align=""justify"">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align=""justify"">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align=""justify"">The measurement of response to the prior course of therapy must be documented in the patient&apos;s medical notes.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9809_9809_R","Management","STREAMLINED","9809","9809","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>WHO Class III, IV or V lupus nephritis</p><br/><p>Management</p><br/><p>The condition must be proven by biopsy; AND</p> <p>Must be treated by a nephrologist or in consultation with a nephrologist.</p> <p align=""justify"">The name of the consulting nephrologist must be included in the patient medical records.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>WHO Class III, IV or V lupus nephritis</p><br/><p>Management</p><br/><p>The condition must be proven by biopsy; AND</p> <p>Must be treated by a nephrologist or in consultation with a nephrologist.</p> <p align=""justify"">The name of the consulting nephrologist must be included in the patient medical records.</p> <p>Management includes initiation, stabilisation and review of therapy as required.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9813_9822_R","Initial treatment - Initial 1 (new patient)","AUTHORITY_REQUIRED","9822","9813","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A partial Mayo clinic assessment of the patient&apos;s response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Department of Human Services website.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND</p> <p>Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or</p> <p>Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Application for authorisation of initial treatment must be in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition; and</p><p align=""justify"">(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].</p> <p align=""justify"">All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.</p> <p align=""left"">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align=""justify"">A partial Mayo clinic assessment of the patient&apos;s response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.</p> <p align=""justify"">A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.</p> <p align=""justify"">If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">Details of the accepted toxicities including severity can be found on the Department of Human Services website.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2019-11-01","Y","4708"
"9820_9651_R","Continuing treatment - balance of supply","AUTHORITY_REQUIRED","9651","9820","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under this restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under this restriction.</p> <p align=""justify"">Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>","N","N","Y","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9821_9823_R","Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)","AUTHORITY_REQUIRED","9823","9821","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition if relevant; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Application for authorisation must be made in writing and must include:</p><p align=""justify"">(a) a completed authority prescription form; and</p><p align=""justify"">(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:</p><p align=""justify"">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient&apos;s condition if relevant; and</p><p align=""justify"">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align=""justify"">A maximum of 14 weeks of treatment with this drug will be approved under this criterion. A loading dose of 200 mg at week 0 and a dose of 100 mg at weeks 2, 6 and 10.</p> <p align=""justify"">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient&apos;s most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align=""justify"">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient&apos;s response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align=""justify"">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align=""justify"">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align=""justify"">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align=""justify"">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align=""justify"">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align=""justify"">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align=""justify"">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align=""justify"">Or mailed to:</p><p align=""justify"">Services Australia</p><p align=""justify"">Complex Drugs</p><p align=""justify"">Reply Paid 9826</p><p align=""justify"">HOBART TAS 7001</p>","N","N","Y","FULL","ALL","N","2019-11-01","Y","4708"
"9828_9828_R","null","STREAMLINED","9828","9828","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchospasm</p><br/><p>Patient must be unable to achieve co-ordinated use of a metered dose inhaler containing a short-acting beta-2 agonist; or</p> <p>Patient must have developed a clinically important product-related adverse event during treatment with another short-acting beta-2 agonist.</p> <p align=""justify"">Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Bronchospasm</p><br/><p>Patient must be unable to achieve co-ordinated use of a metered dose inhaler containing a short-acting beta-2 agonist; or</p> <p>Patient must have developed a clinically important product-related adverse event during treatment with another short-acting beta-2 agonist.</p> <p align=""justify"">Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9831_9831_R","null","STREAMLINED","9831","9831","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of transplant rejection</p><br/><p>The treatment must be used by organ or tissue transplant recipients.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of transplant rejection</p><br/><p>The treatment must be used by organ or tissue transplant recipients.</p>","N","N","N","IMMEDIATE","ALL","N","2019-11-01","N","4708"
"9908_9987_R","Initial treatment","STREAMLINED","9987","9908","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>Patient must not have suspected resistance to either antiretroviral component.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>Patient must not have suspected resistance to either antiretroviral component.</p>","N","N","N","IMMEDIATE","ALL","N","2019-12-01","N","4708"
"9914_9914_R","Management (initiation, stabilisation and review of therapy)","STREAMLINED","9914","9914","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Careful monitoring of patients is mandatory.</p> <p>Management of renal allograft rejection</p><br/><p>Management (initiation, stabilisation and review of therapy)</p><br/><p>Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND</p> <p>The treatment must be under the supervision and direction of a transplant unit.</p>","N","N","N","IMMEDIATE","ALL","N","2019-12-01","N","4708"
"9915_N","null","null","null","null","null","<p align=""justify"">Unlike Symbicort Turbuhaler 200/6, Symbicort Rapihaler 200/6 is not recommended nor PBS-subsidised for use as &apos;maintenance and reliever&apos; therapy as the approved Product Information does not specify such use.</p>","Y","N","N","null","null","N","2014-01-01","N","4708"
"9927_9334_R","null","STREAMLINED","9334","9927","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe spasticity of the lower limb following an acute event</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a plastic surgeon; or</p> <p>Must be treated by a geriatrician; AND</p> <p>The condition must be moderate to severe spasticity of the lower limb/s following stroke or other acute neurological event, defined as a Modified Ashworth Scale rating of 3 or more; AND</p> <p>The treatment must only be used as second line therapy when standard management has failed; or</p> <p>The treatment must only be used as an adjunct to physical therapy; AND</p> <p>The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND</p> <p>Patient must not have established severe contracture in the limb to be treated; AND</p> <p>The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Standard management includes physiotherapy and/or oral spasticity agents.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe spasticity of the lower limb following an acute event</p><br/><p>Must be treated by a neurologist; or</p> <p>Must be treated by an orthopaedic surgeon; or</p> <p>Must be treated by a rehabilitation specialist; or</p> <p>Must be treated by a plastic surgeon; or</p> <p>Must be treated by a geriatrician; AND</p> <p>The condition must be moderate to severe spasticity of the lower limb/s following stroke or other acute neurological event, defined as a Modified Ashworth Scale rating of 3 or more; AND</p> <p>The treatment must only be used as second line therapy when standard management has failed; or</p> <p>The treatment must only be used as an adjunct to physical therapy; AND</p> <p>The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND</p> <p>Patient must not have established severe contracture in the limb to be treated; AND</p> <p>The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter; AND</p> <p>Patient must be aged 18 years or older.</p> <p align=""justify"">Standard management includes physiotherapy and/or oral spasticity agents.</p>","N","N","N","IMMEDIATE","ALL","N","2019-12-01","N","4708"
"9950_C","null","null","null","null","null","<p align=""justify"">Selective serotonin (5HT1) agonists are contraindicated in patients with known or suspected coronary artery disease. The drug should not be used within 24 hours of ergotamine or dihydroergotamine use.</p>","N","Y","N","null","null","N","2014-07-01","N","4708"
"9956_9981_R","Initial treatment","STREAMLINED","9981","9956","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Patient must be antiretroviral treatment naive.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial treatment</p><br/><p>Patient must be antiretroviral treatment naive.</p>","N","N","N","IMMEDIATE","ALL","N","2019-12-01","N","4708"
"9977_N","null","null","null","null","null","<p align=""justify"">Pharmaceutical benefits that have the forms doxycycline tablet 100 mg (as hyclate (hydrochloride)), doxycycline tablet 100 mg (as monohydrate) and doxycycline modified release capsule 100 mg (as hyclate (hydrochloride)) are equivalent for the purposes of substitution.</p>","Y","N","N","null","null","N","2014-04-01","N","4708"
"9991_9993_R","Initial treatment","STREAMLINED","9993","9991","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p><br/><p>Initial treatment</p><br/><p>Patient must have elevated ammonia levels that are not controlled with diet alone and other adjunct care alone.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">An increase in the maximum quantity will be authorised to provide for up to one month&apos;s supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m<sup>2</sup>/day in patients weighing more than 20 kg.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p><br/><p>Initial treatment</p><br/><p>Patient must have elevated ammonia levels that are not controlled with diet alone and other adjunct care alone.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">An increase in the maximum quantity will be authorised to provide for up to one month&apos;s supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m<sup>2</sup>/day in patients weighing more than 20 kg.</p>","N","N","N","IMMEDIATE","ALL","Y","2019-12-01","N","4708"
"9992_9919_R","Continuing treatment","STREAMLINED","9919","9992","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">An increase in the maximum quantity will be authorised to provide for up to one month&apos;s supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m<sup>2</sup>/day in patients weighing more than 20 kg.</p>","<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Urea cycle disorders</p><br/><p>Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align=""justify"">An increase in the maximum quantity will be authorised to provide for up to one month&apos;s supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m<sup>2</sup>/day in patients weighing more than 20 kg.</p>","N","N","N","IMMEDIATE","ALL","Y","2019-12-01","N","4708"